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Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Main Results of the iStoppFallsRandomized Controlled Trial
Rainer Wieching (University Siegen, Germany)on behalf of the iStoppFalls Consortium
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls Funding & ConsortiumiStoppFalls - ICT based System to Predict & Prevent Falls
Consortium
Funding
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls
Study Design
Objectives & Methods
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
ObjectivesiStoppFalls - ICT based System to Predict & Prevent Falls
Objectives
Assessing the feasibility and effects of an ICT-basedfall prevention and prediction system (iStoppFalls) in community-dwelling older adults (> 65 years ).
Primary Objectives:
1) Reduction of Fall Risk, 2) Improvement of Quality of Life
Secondary Objectives:
Physical, Cognitive, Health, Social and Technology Adherence, Usability, User Experience & Acceptance
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Study DesigniStoppFalls - ICT based System to Predict & Prevent Falls
Study Design
Design: Multicenter randomized clinical trial in Europe & Australia
Study Centers: Cologne (n=60), Valencia (n=40), Sydney (n=60)
Participants:160 older adults (80 intervention, 80 control)
Inclusion criteria:Age 65+, Able to walk without aids; Independent Living, Internet Access, HDMI-TV
Exclusion criteria:Severe Diseases: Cardiovascular, Neurologic, Orthopedic, Cancer. Impaired Cognition (MiniCOG), and other severe disorders (vision).
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Overall Study Flowchart
Recruitment
Oral presentation, leaflets, newspaper
Initial contact via phone
Informed consent and baseline assessments
Randomization (n = 160)
GermanyIntervention Group - n = 31
Control Group - n = 30
SpainIntervention Group - n = 22
Control Group - n = 20
AustraliaIntervention Group - n = 29
Control Group - n = 28
16 week iStoppFalls exercise intervention
Assessments post intervention
8-week follow-up with falls calendars
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Methods & MeasurementsiStoppFalls - ICT based System to Predict & Prevent Falls
Measurements
Primary Outcomes: 1) Fall Risk (PPA Score, Lord et al. 2003) 2) Quality of Life (EQ-5D, www.euroqol.org)
Secondary Outcomes:Physical: TUG, SPPB, STS, Gait ST/DT, sensor-basedCognitive: MiniCog, ACE-III, TMT, ANT, DST, VSTHealth: WHODAS, Icon-FES, PHQ-9, PAQ, IPEQTechnology: SUS, PACES, TAM, DART, AFSS
Main outcome variables: repeated measure analysis of variance (ANOVA) or time (pre/post) and group (intervention/control).
Subgroups were tested by ANOVA and independent t-test
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Intervention/ControliStoppFalls - ICT based System to Predict & Prevent Falls
Intervention/Control
Intervention Group: Exergame & SMM Exergame:1) Strength exercise: 3-times per week (60 min per week)2) Balance games: 3-times per week (120 min per week)3) Falls Risk Assessment: at least every 4 weeksExercises and games were due to a progression:Exercises: number of sets, repetitions and weights (1-3 kg)Games: level-difficulty and different dual tasks
SMM: Use the SMM during the whole day (indoors and outdoors).Re-charge it over night.
Control Group: Educational booklet only (falls & fall prevention).
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls
Study Design
ParticipantCharacteristics
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Participant Characteristics iStoppFalls - ICT based System to Predict & Prevent Falls
Intervention Group Control Group Overall P
Mean ± SD n (%)
Mean ± SD n (%)
Mean ± SD n (%)
ANOVA
Age (years) 74.71 ± 6.66 74.65 ± 6.03 74.68 ± 6.34 .960
Gender (n) 43 (55.8%) 50 (66.7%) 93 (61.2%) .185
Drugs (n) 3.52 ± 3.12 3.14 ± 2.49 3.34 ± 2.83 .413
EQ‐5D (index) 0.860 ± 0.120 0.860 ± 0.113 0.860 ± 0.128 .979
PPA (score) .615 ± .886 .546 ± .901 .581 ± .891 .635
Fall history (n) 25 (32.5%) 26 (35.6%) 51 (34%) .732
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls
Results
Adherence
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Drop-OutsiStoppFalls - ICT based System to Predict & Prevent Falls
Intervention Group Control Group Overall
N (%) N (%) N (%)
Full Drop‐Outs 10 (12,8%) 13 (17,3%) 23 (15%)
Drop‐Outs ITT 5 (6,4%) 0 (0%) 5 (3,3%)
Reasons for drop-outs:
Intervention group:technical (5), health (5), moving away (2), new furniture (1), family issues (1), other (1)
Control group: health (7), randomization (3), caring for partner (1), going away (1), other (1)
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Total Exergame AdherenceiStoppFalls - ICT based System to Predict & Prevent Falls
Exercises Games Assessments TOTAL
Sessions per person/week (#) 14 6 1 21Duration per person/week (minutes) 30 19 2 51
Exercises Games Assessments TOTAL
Sessions per person/week (#) 14 6 1 21Duration per person/week (minutes) 20 14 2 36
Raw Data
Cleaned Data
Including instructions
Excluding instructions
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
SMM Measures per PersoniStoppFalls - ICT based System to Predict & Prevent Falls
Distance per person(km)
Wearing time per person (hours)
Distance per time (meter/hour)
SMM Measures (n=70, mean ± SD) 82 ± 62 522 ± 136 140 ± 96
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCTiStoppFalls - ICT based System to Predict & Prevent Falls
Primary Outcomes
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Fall Risk – PPA (total score)iStoppFalls - ICT based System to Predict & Prevent Falls
p < 0.05 (time*group)ANOVA
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Quality of Life EQ-5D (index)iStoppFalls - ICT based System to Predict & Prevent Falls
p = N.S. (time*group)ANOVA
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Overview, iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls
Exercise duration per week
Subgroup Analysis
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Subgroup Analysis: CharacteristicsiStoppFalls - ICT based System to Predict & Prevent Falls
High‐adherence group >90 min.
(n = 18)
Low‐adherence group <90 min.
(n = 53)
P(T‐Test)
Age 73.11 ± 6.70 74.93 ± 6.30 .303
Gender 12 (66.7%) 26 (49.1%) .275
BMI 24.75 ± 3.47 26.54 ± 4.01 .333
Education 11.56 ± 4.81 11.31 ± 4.93 .564
PAQ hours 37.24 ± 17.93 41.92 ± 25.98 .606
IPEQ hours 32.08 ± 11.52 28.64 ± 18.22 .620
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Subgroup Analysis: PPA-Total ScoreiStoppFalls - ICT based System to Predict & Prevent Falls
0,000
0,200
0,400
0,600
0,800
1,000
1,200
Pre Post Pre Post
High-adherence Group (n=18) low-adherence Group (n=53)
PPA Total Score [mean±SE] p < 0.05 (time*group)ANOVA
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Subgroup Analysis: PPA-SwayiStoppFalls - ICT based System to Predict & Prevent Falls
0,000
200,000
400,000
600,000
800,000
1000,000
1200,000
1400,000
Pre Post Pre Post
High-adherence Group (n=18) low-adherence Group (n=53)
PPA Sway ap*ml (mm2) [mean±SE] p < 0.05 (time*group)ANOVA
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Subgroup Analysis: EQ-5D VASiStoppFalls - ICT based System to Predict & Prevent Falls
0,000
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
Pre Post Pre Post
High-adherence Group (n=18) low-adherence Group (n=53)
EQ-5D VAS [mean±SE] p = 0.052 (time*group)ANOVA
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Overview, iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls
Baseline Fall Risk
Subgroup Analysis
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Subgroup Analysis: CharacteristicsiStoppFalls - ICT based System to Predict & Prevent Falls
Low‐PPA Score group < 0.540
(n = 38)
High‐PPA Score group > 0.540
(n = 39)
Control Group(n=75)
P(ANOVA)
Age 73.6 75.5 74.7 .406
Gender 17 (44.7%) 26 (66.7%) 50 (66.7%) .056
BMI 25.6 26.6 26.5 .414
Education 11.5 11.5 11.1 .835
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
Subgroup Analysis: PPA-Total ScoreiStoppFalls - ICT based System to Predict & Prevent Falls
p < 0.001 (time*group)ANOVA
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCT iStoppFalls - ICT based System to Predict & Prevent Falls
Summary & Conclusions
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCT Summary (1)iStoppFalls - ICT based System to Predict & Prevent Falls
Summary
The use of the iStoppFalls system was safe and feasible(usability, accessibility, user experience and acceptance).
Overall adherence to the intervention was good, but did not reach the scheduled dose of exercise (180 min per week) for the exergame alone.
But together with the measures of the daily outdoor activities(SMM), most participants of the intervention group didreach the respective dosage of exercise.
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFalls RCT Summary (2)iStoppFalls - ICT based System to Predict & Prevent Falls
Summary
Primary objective 1) „Reduction of Fall Risk“ could be demonstrated for the whole group (p<0.05).
Primary objective 2) “Improvement of Quality of Life”could not be demonstrated for the whole group.
Subgroup analyses showed promising results:- Exercise Duration (More Training => Lower Fall Risk) - Baseline Fall Risk (High Baseline PPA => Lower Fall Risk)
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFallsiStoppFalls - ICT based System to Predict & Prevent Falls
We thank all Study Participantswww.istoppfalls.eu
Results of the iStoppFalls Randomized Controlled Trial AHA 2015, Magdeburg 4.Sep.2015
iStoppFallsiStoppFalls - ICT based System to Predict & Prevent Falls
Thank You
www.istoppfalls.eu