Upload
lekhue
View
214
Download
1
Embed Size (px)
Citation preview
Table 7.1: Interventions and outcomes for the trials
[Explanation of the symbols used in the table:NS = statistically no significant resultsS/+ = statistically significant results (positive results for the intervention group that supported by technology)S/- = statistically significant results (negative results for the intervention group that supported by technology)NC = No Clear results are described in the article or the measures do not give a clear result because of the qualitative and quantitative characteristics of the measurement and the applied methodology.
⊞ = the trial uses standardized instruments (e.g. scales and guidelines)].
Trial(Articl
e)/Result
s
InterventionsOutcomes
Results Comments
StandardizedInstruments
&scales
(OPAs & CPGs)
Comments about results Impacts
NCT00385034 (Ahmad, et al., 2009) OPAs: Computer-assisted screening: Customization of validated scales on partner’s controlling behavior, physical and sexual violence, and threat of violence and scale on depression
The intervention significantly helped to effectively detect intimate partner violence and control in a busy family medicine practice, and it was acceptable to patients
Effectiveness;Acceptability
⊞S/+
Interactive computer based health-risk survey before doctor's visit (Intervention)Detection of partner abuse during physician-patient medical encounter (audio taped data)
S/+
Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data)
S/+
Patient acceptance of the computer-assisted screening(paper-pencil exit survey)
S/+
DRKS00004685 (Albrecht, et al., 2013) OPAs: A 10-item single-choice test; A Profile of Mood States questionnaire; AttrakDiff2 survey
The intervention revealed significant performance improvement regarding learning efficiency.
Usability; Involvement; Effectiveness (usability and higher level of
⊞S/+
Arm 1: Healthy subjects learn with the "Augmented Reality blended learning environment" (mARble) and answer a 10-item single choice knowledge test and a Profile of Mood States (POMS) questionnaire before and after the learning phase .
Emotional affection compared before and after the S/+1
learning phase with POMS. After the learning phase they fill out the AttrakDiff2 survey.
emotional involvement) as well as learning outcomes (increased learning efficiency).
Learning efficiency before and after the learning phase measured with a 10-item SC-test
NS Pragmatic quality
Learning experience measured with AtrakDiff2 after the learning phase
S/+
NCT01223170 (Antypas, et al., 2014) OPAs: Questions about the intensity of the activity, actual duration of the activity, and free text comment field.The intensity of the activity according to Borg’s scale
Efficacy of theory-based interventions ;Perceived usefulness
Tailored content (Intervention), Generic Internet-based information (Intervention), Discussion forum (Intervention), Behavioral monitoring (Intervention)
Duration and Intensity of Physical Activity (1 months after discharge)
NC
Duration and Intensity of Physical Activity (3 month after discharge)
NC
Duration and Intensity of Physical Activity (12 months after discharge)
NC
Use of online intervention (1 month after discharge) NCUse of online intervention (3 months after discharge) NCUse of online intervention (12 months after discharge) NC
NCT01403831 (Arora, et al., 2012) OPAs: Self-Report Measures (Demographics , Accessibility to/Use of Media/Technology , Smoking , Alcohol , Daily Meal Patterns, Sleep , Depression, Perceived Stress , etc.), Physical Measurements (Height , Weight, Blood Pressure, Heart Rate etc.), Labs (Blood Collection: Lipids, Insulin, Glucose, etc.), Staff (Administered Measures Medication Use and Medication Tracking , Medical Events, etc.)
Effectiveness
S/+
Daily text messages (Intervention)Diabetes knowledge NSDiabetes self-efficacy/empowerment NSDIet/ Weight Loss NCHemoglobin A1C at 6 months NS
2
NCT01092364 (Batch, et al., 2014) CPGs: NCI ASA 24 The behavioral weight loss intervention resulted in body weight reduction.
Effectiveness
S/+ Behavioral weight loss intervention (Intervention) Change in body weight S/+
NCT01958398 (Berman, et al., 2013) OPAs: AUDIT-C(hange); Change in estimated Blood Alcohol Concentration (eBAC)
Effectiveness
(not effective)
⊞
Promillekoll (mobile Intervention); PartyPlanner (web Intervention)
Mobile intervention: -A weekly consumption over the recommended level remained more than 25 percent.
S/-Mobile intervention: -Male participants reported app use increased their drinking frequency from baseline to
S/-Mobile intervention: -Number of app- use occasions S/+Mobile intervention:: -Speaking to someone about use S/+Mobile intervention: -Prior use of Promillekoll NSMobile intervention: -An intention-to-treat analysis NSeBAC-AUDIT - AUDIT-C(hange) (web intervension)(All the measures)-eBAC-AUDIT - AUDIT-C(hange)-app usability-speaking to someone about use-prior use of Promillekoll-Intention-to-treat
NS No significant time-by-group interactions for any outcome measures occurred.
PACTR201304000528276a (Bigna, et al., 2014) Typical measurements Efficacy; Effectiveness
⊞
SMS and Calls vs SMS vs Calls vs ControlEfficacy of interventions S/+ The most
effective method is the combined use of text messages and phone calls (with no synergistic effect between the two).
3
Efficiency of intervention S/+ (a)NS (b)
(a) call versus text message plus call (b) call versus text message
Successful of interventions S/+
ISRCTN10515845 (Crombie, et al., 2013) Adjusted questionnaires The intervention resulted in high level of engagement and satisfaction
A high level of engagement with key components of the behavior change strategy(Perceptions of harms; The benefits of moderated drinking; Intentions for future drinking; The change in frequency of heavy drinking);Satisfaction; Feasibility; Acceptability; Impact
⊞
A series of 28 interactive text messages and images to be delivered.Computer-based tools for assessing cognitive function S/+
NCT00688155 (Espeland, et al., 2013) (examines 2 trials) OPAs: Development of computer-based tools for assessing cognitive function;executive function (five tests);immediate memory (two tests);delayed memory (two tests)
PerformanceUsefulness⊞ Cognitive Training (CT) (Intervention); Physical Activity Training (PAT) (Intervention);
Healthy Aging Education (HAE) (Intervention)Composite of five executive functioning and four episodic memory measures that have been previously validated
NC Not clear but the results support the use of computer-based tools for assessing cognitive function in multicenter clinical trials of
Domain scores [executive function (five tests); immediate memory (two tests); delayed memory (two tests)]
NC
Perceived cognitive functioning problems and quality of life
NC
4
older individuals.Speed of processing, visuospatial skills and verbal fluency
NC
NCT01072500 (Espeland, et al., 2013) (examines 2 trials) OPAs: Development of computer-based tools for assessing cognitive function
Performance; Usefulness
⊞S/+
Lifestyle modification (Intervention) Computer-administered test scores had significant relationships with known risk factors for cognitive deficits and extended the domains being assessed
Cognitive Function S/+Combined outcome of major mobility disability or death
NC
Cost effectiveness NCDisability in activities of daily living (ADLs) NCMajor mobility disability, defined as incapacity to walk 400 m
S/+
Persistent major mobility disability NCSerious fall injuries NC
ACTRN12611000481976 (Fjeldsoe, et al., 2012) Semi-automated collection of data (using call, SMS and online databases)
Physical activity self-efficacy; Social support; Outcome expectancy; Goal setting skills;Perceived environmental opportunity for physical activity.Cost-effectiveness; viability and fidelity
Lifestyle; Behaviour; PreventionBecause the intervention targets constructs of Social Cognitive Theory, the following constructs will be measured: physical activity self-efficacy; social support; outcome expectancy; goal setting skills; and perceived environmental opportunity for physical activity.
NC
Cost-effectiveness: Costs incurred through program delivery, text messages, and staff costs will be monitored. Participants will also answer questions relating to use of health care services and any other costs associated with taking up physical activity.
NC
Program viability and fidelity: All participants recall, use and satisfaction with the program will be assessed using self-report items developed and used previously by the investigators. Responses to program SMS will also be monitored.
NC Not clear report but the e development assessed as a flexible and adaptive to individual participant’s
5
physical activity goals, expectations and environment.
Weekly duration of moderate to vigorous physical activity as measured by the Actigraph GT1M activity monitor and walking for exercise (minutes per week) as measured by the Australian Women's Activity Survey
NC
NCT01598220 (Garrido, et al., 2013) OPAs: A comprehensive battery of neuropsycho- logical tests ((WAIS-III; CPT II; SDMT; CVLT; (WCST-CV3)Heinrichs-Carpenter Quality of Life Scale (QLS)Rosenberg Self-esteem Scale (RSES)
People with schizophrenia improved their neuropsychological performance, QoL and self-esteem measurements through a computer-assisted cognitive remediation therapy;Improved in speed of processing, working memory and reasoning and problem- solving cognitive domains;Clear improvement in quality of life and self-esteem measurements.
Effectiveness (Improvement in Cognition, self-esteem and quality of life)
⊞S/+
Computer-assisted cognitive remediation therapy (Intervention), attentional task (Intervention)
Change in functional outcomes
S/+ and NS
Change in neurocognitive outcomes NC Not clear via the results
IRCT201112158416N1 (Goodarzi, et al., 2012) Typical measurements;Reports
The training via mobile phones led to the had positive results over blood lipids, HbA1C, Self efficacy, Practice, Knowledge
Effectiveness (Impact on knowledge, attitude, practice and self efficacy)
⊞S/+
control group: Did not receive any intervention; intervention group: Training via mobile phone about diabetes type2
Knowledge S/+Attitude NCPractice S/+
Self-efficacy S/+Fasting Blood Sugar NC
6
HgA1C S/+Blood lipids S/+/- Many type of
measurements
NCT00828152 Hedman, et al., 2011) and (Hedman, et al., 2013) OPAs: Quality of Life Inventory,EQ-5D index scores,the Health Anxiety Inventory,the short Health Anxiety Inventory, the Whiteley Index,the Illness Attitude Scale, the Beck Anxiety Inventory, the Anxiety Sensitivity Index,the Montgomery–Asberg Depression Rating Scale – Self-Report, the Mini-International Neuropsychiatric Interview
The internet-based Cognitive-Behavioural Therapy (CBT) revealed superior improvements on measures of health anxiety. Also it is a cost-effective treatment
Effectiveness;cost-effectiveness
Each incremental case of improvement in ICBT relative to the control condition generated a societal cost reduction of £1244.
⊞S/+
Internet-based cognitive behaviour therapy (ICBT) of severe health anxiety or hypochondriasis
Illness Attitude Scale (IAS) S/+ Immediately pre and post treatment,and 6 and 12 month follow up
Whiteley Index (WI) S/+ Immediately pre and post treatment, and 6 and 12 month follow-up
Montgomery–Asberg Depression Rating Scale – Self-Report (MADRS-S)
S/+ Immediately pre and post treatment, and 6 and 12 month follow-up
Health Anxiety Inventory (HAI) S/+ 3 days before treatment start12 weeks after pre assessment6 months after post assessment12 months after post assessment
Beck Anxiety Inventory (BAI) S/+ Immediately pre and post treatment, and 6 and 12 month
7
follow-upQuality of Life Inventory (QOLI)
EuroQol Questionnaire (EQ-5D)
S/+ Immediately pre and post treatment, and 6 and 12 month follow-up
Cost-effective treatment S/+ gained QALYWilcoxon tests
Illness Attitude Scale (IAS) S/+ Immediately pre and post treatment,and 6 and 12 month follow up
ACTRN12607000437460 (Kay-Lambkin, et al., 2011) OPAs: Global AssessmentOptiate Treatment IndexCPGs: A clinician- assisted computer-based (CAC) psychological treatment (delivered on DVD) for comorbid depression and alcohol or cannabis use problems.Reduction in cannabis use as measured by the Optiate Treatment Index
Effectiveness;Acceptability
S/+
Behaviour; Treatment: Other ; LifestyleImprovement in general functioning as measured by the Global Assessment of functioning
NS But the potential for computer-based self-help treatments is promising
Reduction in alcohol use as measured by the Optiate Treatment Index
NS
Reduction in cannabis use as measured by the Optiate Treatment Index
NS
Reduction in depression scores as measured by the Beck Depression Inventory II
NS
ISRCTN67370244 (Kearney, et al., 2009) OPAs: Symptom questionnaire (e.g. Common Toxicity Criteria Adverse Events and Symptom Assessment Scale).CPGs: An ‘amber alert’ system. This alert participants’ clinicians of the important incoming symptom reports.
Significantly higher reports of fatigue in the control group compared to the intervention group
Mobile phone system would provide a more accurate reflection of chemotherapy toxicity and provide a better means of monitoring chemotherapy-
S/+ This study will evaluate the effectiveness of using a mobile phone in the home, monitoring and symptom management of patients receiving chemotherapy for colorectal cancer, lung and breast cancer. Participants in the control group receive standard care and
Changes in chemotherapy toxicity as a result of use of the mobile phone system and supporting information technology (IT) infrastructure
NC NC but:- higher results in the intervention group
Symptom outcomes (nausea, vomiting, fatigue, mucositis, hand–foot syndrome and diarrhoea)
S/+/- Significantly higher reports of fatigue in the
8
control group compared to the intervention groupSignificant difference:-hand–foot syndrome were on average lower in the control group
related morbidity,
NCT01144767 (King, et al., 2013) OPAs: The Community Healthy Activities Model Program for Seniors Questionnaire; the Working Alliance Inventory; the Computer Attitude Scale; Physical activity decisional balance; Working Alliance Inventory (a 36-item instrument)
The results of this trial indicate that a virtual advisor delivering culturally and linguistically adapted physical activity advice led to meaningful 4-month increases in walking
Behavior Change;Safety;Continued Use;Ease of Use and Acceptability After Study End; Use⊞
S/+
Activities of Daily Living, Communication, Exercise, Health Behavior, WalkingSteps per day measured by accelerometry S/+Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
NS
Computer Attitude Scale (which assesses users' computer-related confidence, liking, and anxiety)
NS
Physical activity decisional balance (measures the relative importance of positive and negative aspects of physical activity)
NS But not clear enough
Physical activity self-efficacy S/+Working Alliance Inventory (a 36-item instrument that assesses users' attitudes towards the computerized "advisor")
S/+
NCT01655264 (Kizony, et al., 2013) OPAs: Structured questionnaires(e.g. Functional Independence Measure, Chedoke Arm and Hand Activity Inventory (CAHAI-7), Fugl-Meyer Motor Assessment upper extremity sub-test, Functional Reach TestInstrumental Activities of Daily Living, Range of Motion of shoulder and elbow, Stroke Impact Scale,
Functional UsabilityS/+ Tele-rehabilitation exercises for weak upper extremity (Intervention), Home-based self-
training exercises for weak upper extremity (Intervention)Functional Independence Measure (FIM) NSChedoke Arm and Hand Activity Inventory (CAHAI-7) NSFugl-Meyer Motor Assessment (FMA) upper extremity sub-test
NS
Functional Reach Test (FRT) NS But, significant within group differences were found and those were different between the two
9
groups. Visual Analog Scale for pain evaluation)Instrumental Activities of Daily Living NS
Range of Motion (ROM) of shoulder and elbow NSStroke Impact Scale (SIS) NSVisual Analog Scale (VAS)for pain evaluation NS
ISRCTN27988779 (Lana, et al., 2014) Reported documentation (e.g. about the reduction of cancer risk linked with smoking, unhealthy diet, alcohol consumption, obesity, sedentary lifestyle and sun exposure).
The Total cancer behavioral risk was significantly reduced in the experimental groups
Effectiveness: Useful in controlling overweight adolescents.Improving the post-test total cancer behavioral risk
The trial has two arms: subjects of the experimental group have free access to the whole sections of the website during one academic course and will receive around 40 mobile phone text messages (one per week). The website includes: 40 challenges or problems to be solved, discussion forums, games, information and links, diet analysis and educational videos.
Cancer risk behaviors (smoking, diet, alcohol consumption, sun exposure, sedentarism and overweight)
NC Some results slightly better but not clear in the
Global cancer behavioral risk indicator S/+ The TCBR was significantly reduced in the experimental groups. A customized website achieved a modest impact on cancer behavioral risk control when supplemented with text messages.
NCT00383461 (Linder, et al., 2009) Typical report documents(e.g. the proportion of documented smokers who made contact with a smoking cessation counselor, Coded smoking status documentation and medication prescribing).
The intervention improved smoking status documentation and increased counseling assistance to smokers
Efectiveness: Stop smoking; Helpful: Improved smoking; Status documentation.Increased Counseling
⊞ Behavioral: smoking cessation intervention; Other: counseling intervention
Coded documentation of smoking status
S/+
Coded documentation of counseling assistance S/+
10
assistance to smokers but not the prescription
Coded documentation of the prescription NS
NCT01821222 (2 articles) (Lund, et al., 2014) Typical measurements The studied intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy. Also there was a trend towards improved quality of care in terms of preventive health services, antenatal care late in pregnancy and antepartum complications identified and referred.
EffectivenessImproved quality of care(Significantly increased the proportion of women receiving the recommended four antenatal care visits.Improved maternal and newborn health and should be considered by policy makers in resource-limited settings).
⊞
Wired mothers (Intervention)Antenatal care attendance S/+Perinatal mortality S/+Skilled delivery attendance
NCT00512837 (Malhotra, et al., 2012) (Ryan, et al., 2012) OPAs: Asthma control questionnaire;Knowledge, attitude, and self-efficacy asthma questionnaire; Typical measurements
Effectiveness (not effective)Cost effectiveness (not cost effective)
⊞
Mobile phone technology (Intervention)Change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference
NS
Morbidity • Mean difference in ACQ at 3 and 6 months.24,36 • Proportion of patients with an ACQ<0.75 at three and six months.27 • Mean difference in mini-AQLQ which measures the physical/emotional impact of asthma on a scale
NS
Cost-effectiveness S/-
11
PACTR201011000261458 (Mbuagbaw, et al., 2013) Typical measurements Used mobile phone text messages to improve adherence to antiretroviral medication enhances communication between patients and health workers.
Not clear results.
Satisfaction;FeasibilitySMS/+ vs Usual care
Adherence NCBody Mass Index NCCD4 count NCCDC Classification NCMortality NCOpportunistic infections NCQuality of life NCViral Load NCWeight NCWHO Classification NC
ISRCTN72614272 (McKinstry, et al., 2013); (Stoddart, et al., 2013) OPAs: the EuroQol-5D index scores;an Anxiety and depression scale;the Depression scale.Τhe Asthma symptom scores;Typical measurements;ReportsCPGs: a local guideline for hypertension management and additional guidance for escalating therapy
The use of telemonitoring can can significantly reduce systolic and diastolic ambulatory blood pressure
Effectiveness
⊞S/+
Α telemetric home blood pressure monitoring service. This trial is also a qualitative study of a different model of service involving interviews and focus groups.
Prescriptions for anti-hypertensives taken from GP practice records
NC
Anxiety and depression, assessed by the Hospital Anxiety and Depression (HAD) scale
NS
Average daytime systolic blood pressure at 6 months measured by ambulatory monitoring
NS OR S/+
Different in subgroups
Average diastolic blood pressure S/+Body mass index NSBreath carbon monoxide NCGrip strength NC Not measuredHbA1c NSHealth care providers' experiences and opinions of this service
NC
Number of attendances at practice nurse, GP, accident and emergency and out of hours care
S/+
Number of telephone/email contacts with practice nurses and GPs
S/+
Prescriptions for anti-hypertensives taken from GP practice records
NC
Quality of life (Euroqol) NS
12
Self-efficacy and medication adherence NSSelf-reported alcohol intake and smoking S/+
Self-reported exercise frequencyNC Found to be too
complexSelf-reported exercise tolerance NSSerum cholesterol NSSpot urinary sodium/creatinine ratio NS
NCT00367263 (Meltzer, et al., 2008) Asthma symptom scores (Daytime/Nighttime), nocturnal awakenings, Peak expiratory flow rate (PEFR) and use of rescue medication (albuterol metered dose inhaler) as recorded by the subject on the traditional paper diary and the VOCEL® Mobile Diary.
Ease of use;Preference;Compliance;Behavior change;Clinician assessment;drug assessment
Alvesco (Ciclesonide) 160 ug/day Determination of patient generated assessment of ease of use of Alvesco® (ciclesonide) in regards to learning, daily use and difficulties experienced.
NC
Asthma symptom scores (Daytime/Nighttime), nocturnal awakenings, Peak expiratory flow rate (PEFR) and use of rescue medication (albuterol metered dose inhaler) as recorded by the subject on the traditional paper diary and the VOCEL® Mobile Diary.
NC The ciclesonide metered dose inhaler was safe, effective, and easy to use. But, these entries may not be completely reliable.
Change from baseline to end of treatment of FEV1. NCChange from baseline to end of treatment of peak expiratory flow.
NC
Clinician generated assessment of the traditional paper diary and the VOCEL® Mobile Diary.
NC
Determination of subject compliance with Alvesco® (ciclesonide), study medication dosing, as recorded on a traditional paper symptom diary and the VOCEL® Mobile Diary.
NC
To determine subject preference of a traditional paper symptom diary vs. the VOCEL® Mobile Diary.
S/+
NCT00244868 (Meropol, et al., 2013) OPAs: Α coding scheme to transcripts and design yes/no questions immediately after the first consultation;
Satisfaction with discussion about treatment options
CONNECT program made treatment decisions easier
⊞S/+
educational intervention (Intervention), counseling intervention (Intervention)Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions
S/+
13
immediately after the first consultation Decisional Conflict Scale;Treatment Options Expectations Scale;12-Item Short-Form Health Survey for satisfaction;
Satisfaction with discussion about support/community services
to reach and helped them to be more satisfied with these decisions.Patients reported higher levels of satisfaction with physician communication format and discussion regarding support services and quality of life concerns
Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion
S/+
Expectations regarding potential benefits and adverse reactions associated with treatment options by Treatment Options Expectations Scale given immediately after the first consultation and at 3 months after study completion
S/+
Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation
NSS/+
12-Item Short-Form Health Survey for satisfaction (NS);Satisfaction with discussion about diagnosis/prognosis (NS);Satisfaction with discussion about treatment options (NS);Satisfaction with discussion about support/community services (S/+);Satisfaction with discussion about QOL (S/+);Satisfaction with format of communication (NS);Overall Satisfaction (23 Questions) (S/+);A vs B (physician)A vs C (No physician)
14
A vs B/C (physician and No physician)
NCT00558233 (Miller Jr, et al., 2011) OPAs: Screening test ordered;Reported a test preference after program;Reports
A web-based decision aid increased patients’ ability to form a test preference and their intent to receive screening, regardless of literacy level
Effectiveness:
Colorectal cancer screening reduces mortality yet remains underutilized. But the web-based decision aid increased patients’ ability to form a test preference and their intent to receive screening,
⊞S/+
YourMeds patient education program (Intervention), CHOICE decision aid (Intervention) Provider ordering a colorectal cancer screening test NC ReportChange in participants' readiness to be screened (Stage of Change)
S/+ Report
Number of polyps and cancers found by screening tests performed
NC Screening test ordered at first visit
Participant acceptance of computer program NS ReportParticipant completion of computer program without assistance
NS Report
Receipt of colorectal cancer screening NC ReportSelf-reported intent to discuss colorectal cancer screening with healthcare provider
S/+ Reported a test preference after program; Increased readiness for screening after program
NCT00415870 (Norman, et al., 2013) Reports; Subjective ratings of intervention components and ease of use;Objective measures of frequency of use.
Behavioral: Printed Material;Behavioral: Weekly Weighing;Behavioral: Cell phone will serve as a self-monitoring device;Device: Text Message;Behavioral: Diet Goals via Cell Phone;Behavioral: Food Monitoring
Access satisfaction;Satisfaction; Assess Compliance With Food
⊞ Text Message (Intervention), Diet Goals via Cell Phone (Intervention); Cell phone will serve as a self monitoring device (Intervention); Food Monitoring (Intervention), Weekly Weighing (Intervention); Printed Material (Intervention)
The effect of the mDIET system in comparison to a control group on BMI among overweight men and women.
S/+
to assess compliance with food monitoring activities (e.g. type of food, amount) via the cell phone. Compliance will be measured as a percentage of monitoring logs completed and submitted via phone
S/+
to assess satisfaction with mDIET. Satisfaction will be measured by subjective ratings of intervention
S/+
15
components and ease of use, and objective measures of frequency of use.
ACTRN12611000117910 (Pfaeffli, et al., 2012) OPAs: Quality Adjusted Life Year (QALY);SF-36;A 6-minute walk test;The International Physical Activity Questionnaire (IPAQ);Typical measurements;
Effectiveness
⊞
Behaviour; Other interventions; RehabilitationChange in maximal oxygen uptake (VO2max) from baseline to 24 weeks
NC
Cost-effectiveness - Cost information, including cost of programme, and direct medical costs (including cost of treatment, primary care, secondary care and over-the-counter medications) and Quality Adjusted Life Year (QALY)
NC -Cost of treatment, primary care, secondary care and over-the-counter medications-Quality Adjusted Life Year (QALY)
Health related quality of life (SF-36) NCPhysical function measured with the 6-minute walk test NCTotal physical activity (MET-minutes per week) measured with the International Physical Activity Questionnaire (IPAQ)
NC
NCT01058694 (Pop-Eleches, et al., 2011) 19 combinations of measures (e.g measures about the adherence to text Message Reminders (daily or weekly reminders), Intention-to-treat analysis (short and long reminders), Per-protocol analysis (daily and weekly reminders) etc
A SMS reminders tool achieved adherence of at least 90% compared with 40% of participants in the control group. Participants receiving weekly SMS reminders were also less likely to experience treatment interruptions
Improvement of adherence given the convenience and low cost of deliveringIntention-to-treat analysis.Only 2 types of measures (from 19) were slightly less than the control group.
⊞
Short Message Services to Support ARV therapy adherence (Intervention)Frequency/incidence of ARV treatment interruptions S/+/-MEMS Adherence S/+
ACTRN12610000625077 (Proudfoot, et al., 2013) OPAs: Mean Depression The intervention revealed Effectiveness:
16
Anxiety Stress Scales score;Subjective Units of Distress Scales;A questionnaire asking for details about participants use of varying health services and medications;Work & Social Adjustment ScaleCPGs: an adopted six-item questionnaire developed using Bandura's guidelines
significantly greater improvement in symptoms of depression, anxiety, stress and in work and social functioning
Improvement in the treatment
⊞S/+
Treatment: Devices; Behaviour; Other interventionsMean Depression Anxiety Stress Scales (DASS) score S/+Self-efficacy for coping with Depression, Anxiety and Stress. This will be assessed using our new six-item questionnaire developed using Bandura's (2006) guidelines
NC
Subjective Units of Distress Scales (SUDS) NCUtilisation of Health Services. This will be assessed using a questionnaire asking for details about participants use of varying health services and medications
NC
Work & Social Adjustment Scale S/+
NCT00794222 (Reid, et al., 2011) OPAs: The Session Rating Scale, the Depression, Anxiety, Stress Scale; the Short-Form 12 Heath Survey; the General Practice Assessment Questionnaire communication subscale; the Senior House Officers Appraisal Form; Emotional Self-Awareness Scale; The Party Project’s Exit Interview;
The intervention significantly increases Emotional Self-Awareness (ESA)
Efectiveness:improved mental health outcomes
⊞S/+
Mobile Tracking Young People's Experiences (mobiletype) (Intervention)Depressive symptoms NSDetection of mental health problems S/+Emotional Self-awareness S/+Pathways to care NCPatient's satisfaction with their GP NC
NCT01584882 (Rindal, et al., 2013) CPGs: A user-centered design principles and guided development of the Computer-Assisted Tobacco Intervention (CATI) tool
A clinical decision support tool within an electronic health record proves to be effective at improving tobacco-cessation efforts for patients who smoke cigarettes
Effectiveness
⊞S/+
CATI Tool (Intervention)Patient report (Patient-smokers assessed their interesting quitting; Patient-smokers reported that their dental provider suggested specifıc strategies for quitting)
S/+
Providers report( Providers referred the patient to a tobacco quit line)
S/+
17
ACTRN12611000081910 (Short, et al., 2014) OPAs: Physical Activity Questionnaire; Nutrition/Food Questionnaire; Physical Activity Literacy Questionnaire; Nutrition Literacy Questionnaire
Text message plus phone call was the most effective reminding method, but text messaging alone was the most efficient (i.e., cost-effective) method
Effectiveness
⊞S/+
LifestyleParticipants wll be asked to complete the following survey instruments and have the following measurements taken at each data collection time point. Physical Activity. Questionnaire. Nutrition/Food Questionnaire. Physical Activity Literacy Questionnaire.Phase 1 - Control Group and IT Group: All individuals will be provided with a detailed information sheet and an informed consent form. They will have their data recorded at a time convenient for them. Participants will complete the survey instruments (SurPhase 2 - Sub-sample group: All individuals will be fitted with an accelerometer and will have objective measures taken of their height and weight whilst completing the same intervention as Phase 1 participants
NS and S/+
The most messurements were no significant (The IT-based group consumed a significantly lower number of serves of red meat)
NCT00731315 (Stein, et al., 2011) Questionnaire (with 29 simply phrased questions); Typical measurements; reports and documents (measure the overall satisfaction)
The computer-expedited management group had lower median visit duration.2.No significant difference between groups3.No significant difference between groups
An interactive computer kiosk accurately, efficiently, and safely expedited the management of women with uncomplicated urinary tract infections.Improve Emergency Department patient flow (administrative issue)
⊞
Computer-assisted treatment group (Intervention); Usual care group (Intervention)
Patient acceptability of treatment by computerNC Overall satisfy
actionThe proportion of subjects with treatment failure or relapse
S/+andNS
1.Time spent in Emergency Department 2.Illness resolution 3.Number of return visits
NCT01398488 (Suhling, et al., 2014) Questionnaire; Documentation; Typical
Effectiveness;cost effectiveness.Patient education (Intervention)
18
⊞
measurementsAdherence NSCalcineurin trough levels NSCalcineurin trough levels variability NSGlomerular filtration rate NSInterval Adherence NSImmunosuppression levels S/+Knowledge Improvement NS
and S/+
Self rated adherence NSTotal time of answering questionnaire NSTotal time of education NSTrough level interval NCCost-effectiveness NC
NCT00818285 (Tamblyn, et al., 2012) Typical measurements(Rate of potentially inappropriate psychotropic medication)
The intervention reduced the risk of injury by 1.7‰
Effectiveness
⊞Computerized drug alerts for psychotropic drug management (Intervention)
Rate of potentially inappropriate psychotropic medication
S/+
NCT00297869 (Terrell, et al., 2009) CPGs: a computer-assisted order entry system with decision support
A computer-assisted decision support intervention significantly reduced the probability of inappropriate prescribing to older adults.
Effectiveness(Significantly reduced prescribing of potentially inappropriate
⊞S/+
Computer-Assisted Decision Support (Intervention)Proportion of ED patients who receive an excessive dose of a medication that requires dosage adjustment for renal insufficiency
S/+
Proportion of older ED patients who receive a potentially inappropriate medication
NS Similar between the groups but there were some exceptions
NCT01139255 (Turner-McGrievy, et al., 2011) (Turner-McGrievy, et al., 2013)
Questionnaire; Measurements informational, tangible assistance, esteem, network, Podcasting + mobile media (Intervention)
Weight loss (Podcasting) NS
19
and emotional support
Weight loss (Podcasting + mobile media) NC But reported a minimally intensive weight-loss intervention
NCT00886730 (Van Voorhees, et al., 2013) OPAs: the Patient Health Questionnaire-9
The intervention group showed significant greater participation than the control groups.Referral of primary care patients to an Internet-based social support group portal was effective. Also, a patient-oriented brochure primarily focused on eliciting internal motivations demonstrated greater participation on multiple measures with moderate effect sizes than a generic medical letter of recommendation.
FeasibilityHelpfulnessSafetyAdherence
⊞S/+
Simple Card (Intervention), Physician's endorsement (Intervention); Patient Centered Brochure (Intervention)
Feasibility, helpfulness and safety of Internet site S/+
Percentage visiting the Internet site
S/+
NCT00348751 (van Wyk, et al., 2008) CPGs: CholGate: a Computerized clinical decision support system
The intervention improved the percentage of correctly treated and screened patients
Significantly improved screening and treatment performance for dyslipidemia
⊞S/+
CholGate (Intervention)The percentage of correctly screened patients using anonymous patient record data.
S/+
The percentage of correctly treated patients using anonymous patient record data.
S/+
ACTRN12611001257954 (Watts, et al., 2013) OPAs: World Health Organization Short Disability Assessment Scale, the Patient Health Questionnaire-9, Beck's Depression Inventory II assessment of Depression,
The delivery a CBT program through a mobile application, resulted in significant improvements in outcomes for patients with depression
Effectiveness
⊞S/+
Behaviour; Treatment: OtherBeck's Depression Inventory (BDI) II assessment of Depression
S/+
Kessler Psychological Distress Scale 10 Item (K-10), a measure of pscyhological distress
S/+
20
the Kessler Psychological Distress Scale 10 Item, the Kessler Psychological Distress Scale 10 Item, the Credibility/Expectancy Questionnaire, the Sheehan Disability Scale, the Mini-International Neuropsychiatric Interview and the Environment rating scale
Patient Health Questionnaire-9 (PHQ-9) is a 9 item depression scale.
S/+
The World Health Organization Short Disability Assessment Scale (WHODASS -II ) is a tool for the assessment of disabilities in selected areas of functioning for people with mental disorders
NC
ACTRN12606000476538 (Whittaker, et al., 2011) OPAs: A scale that measures continuous smoking abstinence (as defined by the Russell standard); Questionnaire (plus via SMS)
Satisfaction; effectivenessBehaviour
Continuous abstinence NSCost per quitter and satisfaction with programme S/-Point prevalence abstinence NS
ACTRN12609000405213 (Whittaker, et al., 2012) OPAs: Pediatric Quality of Life Questionnaire, the Reynolds Adolescent Depression Score and the Child Depression Rating Scale-Revised
The intervention group found the mobile phone depression prevention tool helpful – significantly higher than the control group
SatisfactionPerceived usefulnessAdherence
⊞S/+
Behaviour; PreventionChange in depressive symptoms as measured by the Child Depression Rating Scale-Revised (CDRS-R).
S/+ Positive results except the maters about help to be healthy and safe for using the Internet and mobile phone
Overall functioning and quality of life assessed by the Pediatric Quality of Life Questionnaire (PQ-les-Q)
S/+/-
Self-rated depressive symptoms assessed via the Reynolds Adolescent Depression Score (RADS-2), Moods & Feelings Questionnaire
S/+
21
Table 7.2: Aggregated results of HIT interventions in RCTs according to the use of standardized HIT tools
Results Standards tools
With OPA/GPG usage Not OPA/GPG usage TotalPositive results 19 (17,45) 5 (6,55) 24No positive results
13 (14,55) 7 (5,45) 20
Total 32 12 44
Table7.3: Aggregated results of HIT interventions in RCTs according to the use of standardized HIT tools used for statistical results
With_Not OPA/GPG usagePositive_ No positive results
1 W Pos2 W Pos3 W Pos4 W Pos5 W Pos6 W Pos7 W Pos8 W Pos9 W Pos10 W Pos11 W Pos
22
12 W Pos13 W Pos14 W Pos15 W Pos16 W Pos17 W Pos18 W Pos19 W Pos20 W Neg21 W Neg22 W Neg23 W Neg24 W Neg25 W Neg26 W Neg27 W Neg28 W Neg29 W Neg30 W Neg31 W Neg32 W Neg33 N Pos34 N Pos35 N Pos36 N Pos37 N Pos38 N Neg39 N Neg40 N Neg
23
41 N Neg42 N Neg43 N Neg44 N Neg
Table7.4: Statistical results of HIT interventions in RCTs according to the use of standardized HIT tools
With_Non * Posit_NoPositive Crosstabulation
Posit_ NoPositive
TotalNo positive Pos
With_Non N Count 7 5 12
% within
Posit_NoPositive
35,0% 20,8% 27,3%
W Count 13 19 32
% within
Posit_NoPositive
65,0% 79,2% 72,7%
Total Count 20 24 44
% within
Posit_NoPositive
100,0% 100,0% 100,0%
24
Chi-Square Tests
Value df
Asymp. Sig. (2-
sided)
Exact Sig. (2-
sided)
Exact Sig. (1-
sided)
Pearson Chi-Square 1,104a 1 ,293
Continuity Correctionb ,505 1 ,477
Likelihood Ratio 1,102 1 ,294
Fisher's Exact Test ,329 ,238
N of Valid Cases 44
a. 0 cells (,0%) have expected count less than 5. The minimum expected count is 5,45.
b. Computed only for a 2x2 table
25
26