School of Nursing Center for Gerontological Nursing A Randomized Trial of Exercise, Education, and Risk Reduction Counseling to Prevent Falls in a Population-Based

School of Nursing

Center for Gerontological Nursing

A Randomized Trial of Exercise, Education, and Risk Reduction Counseling to Prevent Falls in a

Population-Based Sample of Older Women

Jean F. Wyman, PhD, RNCynthia R. Gross, PhD

Richard P. DiFabio, PhD, PTRuth A. Lindquist, PhD, RN

Teresa C. McCarthy, MDJohn A. Nyman, PhD

Michael G. Wade, PhDMary J. Findorff, PhD, RNJoseph A. Konstan, PhD


Acknowledgments• National Institute of Nursing Research and Office of

Women’s Health Research, National Institutes of Health (R01 NR05107)

• School of Nursing, University of Minnesota


Research TeamCo-Investigators• Cynthia R. Gross, PhD• Richard P. DiFabio, PhD, PT• Joseph A. Konstan, PhD• Ruth A. Lindquist, PhD, RN• Teresa C. McCarthy, MD• John A. Nyman, PhD• Michael G. Wade, PhD

Other Team Members• Mary J. Findorff, PhD, RN• Nancy Nachreiner, PhD, RN• Jennifer Peters, PhD, RN• Holly Stock, MS, MA• Helen Reid, MS

• Melinda Monigold, MS, FNP• Kristine Talley, MS, GNP• Catherine Croghan, BSN, MS• Lois Gildea, BSN, RN• Carrie Gomez, BSN, RN• Mary Edwards, BSN, RN• Jenny Cristobal• Mary Eichten• Kelly Hughes• Allison Mumbleau• Sean Lamb-Vosen• Sonja Theobald, BS• Pat Minor, BA


Background• Falls are a prevalent, serious, and costly problem

affecting older adults, particularly older women

• Multifactorial interventions conducted by a multidisciplinary team that include exercise and are targeted to high risk individuals are recommended to prevent falls

• Most fall prevention studies have been based on convenience samples limiting understanding of how these interventions work in the general population

• Further research is needed to test strategies that will be effective in reducing falls in at-risk populations


Aim• Test the efficacy of a multifactorial fall prevention

program in reducing falls in a population-based sample of community-dwelling older women deemed at risk for falling

- Primary Hypothesis:

• Participants in the fall prevention program will experience fewer falls than those in a health education program (attention control)

- Secondary Hypothesis

• Participants in the fall prevention program will have fewer fall-related injuries


Design

• Randomized controlled, single-blinded trial with 2-arms

- Multifactorial fall prevention program

- General health education program (control)

• Probability-based sample involving mailed invitations to female Medicare enrollees within 12 mile radius of University

• Age-stratified randomization using permutated block design

• Baseline with 1-year of monthly follow-up

• Modest honorarium ($25 per assessment visit)


Eligibility Criteria• Female Medicare beneficiaries ≥ 70 years • Reside outside a nursing home• Mentally intact (MMSE > 23)• Able to walk 30 feet without stopping with/without

assistive device• Evidence of postural instability and minimum of one

other injurious fall risk factor• Not currently involved in regular exercise• Free from conditions that would prohibit safe,

independent exercise • Physician clearance for exercise participation• Be able to read and understand English• Have touch-tone phone service


Baseline Evaluation• History and Physical Exam

• Mini-Mental State Exam

• Berg Balance Test

• Timed Get-Up and Go Test

• 8-Foot Timed Walk

• Timed Chair Elevations

• Tandem Walk

• Hip Strength

• Modified Home Environmental Survey

• Lubben’s Social Network Scale

• SF-36 Health Survey

• Cantril Self-Anchoring Scale

• Geriatric Depression Scale

• Risk-Taking Questionnaire

• Physical Activity Scale for the Elderly

• Fear of Falling

- SAFE- ABC Scale

• Exercise Stage of Adoption, Self-Efficacy, Decision Balance, and Processes of Change Scales


Intervention Components- 28 week program in two phases:

• 12 weeks, alternating biweekly home visits and telephone calls by baccalaureate-prepared registered nurses

• 16 weeks, tapered interactive computerized telephone support and monitoring

- Instructional manual

Fall Prevention Program• Based upon Transtheoretical Model of Behavior

Change and empirical findings

• Comprehensive risk assessment by nurse practitioner

• Exercise program

- Graded walking program (30 minutes for minimum 5 days/week)

- Balance, strength, and coordination exercises (11 exercises; 12 repetitions; weighted belt in selected exercises; minimum 2 days/week)

• Fall prevention education

• Tailored risk reduction counseling using action plan

• Exercise relapse prevention strategies

• Provision of 2 nightlights


Falls Definition and Measurement

• Fall Definition:

- Unintentional event that results in a person coming to rest on a lower level, other than as a consequence of sustaining a violent blow, loss of consciousness, sudden onset of paralysis, or an epileptic seizure (Kellogg International Workgroup, 1987)

• Prospective Measurement:

- Daily fall calendar mailed in monthly with follow-up telephone interview on all falls reported


Injury Event Definitions• Minor

- Abrasions, soft tissue injuries, lacerations not requiring sutures, and sprains

• Moderate

- Injuries resulting in evaluation or treatment by a health care provider,diagnostic tests such as x-rays, or resulting in 3 day activity restriction

• Major

- Fractures, head injuries resulting in hospitalization, joint dislocations, lacerations requiring sutures

• If multiple injuries sustained for same injury event, classification based on the most severe rating

Assessed for eligibility(N=4112)

Eligible and Randomized

(N=272)

Excluded (n=3840)Non response (n=1332)Ineligible (n=1200)Refused (n=965)Other (n=343)

Allocated to Fall Prevention (n=137)

12-Week AssessmentComplete (n=131)Withdrawals (n=6)

Allocated to Health Education (n=135)

12-Week AssessmentComplete (n=132)Withdrawals (n=3)

1-Year AssessmentComplete (n=127)Withdrawals (n=9)Deaths (n=1)

1-Year AssessmentComplete (n=130)Withdrawals (n=4)Deaths (n=1)

Study Flow


Sample Characteristics (N=272)Characteristic Fall Prevention

(N=137)N (%) or M ± SD

Health Education(N=135)

N (%) or M ±SD

Baseline age 78.5 ±5.3 79.0 ±5.9

White 133(97.1) 135(100)

Lives alone 68(49.6) 65(48.1)

≥ High School Education 85(62.0) 78(57.8)

Income ≥ $20,000/year 76(55.5) 64(47.4)

History of falling in past year 52(38.0) 54(40.0)

# Chronic conditions 2.6±1.6 2.9 ±1.6

# Weekly prescription drugs 3.5 ±2.5 3.8 ±2.6

SF-36 Physical function 61.2 ±23.2 63.2 ±20.9

Very good or excellent self-rated health 46(33.6) 50(37.0)

Geriatric Depression Scale Score 1.9 ±2.1 1.7 ±2.3


Sample Characteristics (N=272)

Characteristic Fall Prevention(N=137)

N(%) or M ± SD

Health Education(N=135)

N (%) or M ± SDMini-Mental State Exam Score 28.5±1.5 28.1±5.9

Body mass index 28.1±5.4 28.1±5.9Use of assistive device 25(18.2) 33(24.4)Berg Balance Test 48.9±5.7 48.9±5.5

8-foot timed walk (seconds) 3.1±1.9 2.9±1.4Timed chair elevations (seconds) 16.0±6.1 15.6±5.7Timed Up and Go Test (seconds) 13.1±11.4 12.1±4.2Hip Strength 130.9±41.7 136.1±43.3


Fall Frequency at 1 Year

0

20

40

60

80

100

0 1 2 3 4 or More

Number of Falls

Number of Participants

Fall Prevention Health Education


Fall Outcomes Over 1-YearOutcome Fall Prevention

(N=131)Health Education

(N=132)

Number of falls 84 119

Number of nonfallers (%) 77(56.2) 72(53.3)

Number of fallers (%) 54(41.2) 60(45.5)

Number of repeat fallers (%) 14 (10.7) 24 (18.2)

Number of injurious fallers* (%) 14 (10.7) 18 (13.6)

Number of single, injurious fallers* (%)

13(9.9) 15(11.4)

Number of multiple, injurious fallers* (%)

1(.8) 3(2.3)

Time to first fall in days (M±SD) 173.9 ± 130.7 150.8 ± 148.9

*Includes moderate and severe injuries


Fall Rate Per 100 Person Years

Fall Prevention Health Education

Fall rate per 100 person years* 63.7 88.8

Incidence Rate Ratio: 0.717 (95% CI: 0.535-0.955)

*P < .01


Type of Injury

0

10

20

30

40

50

60

70

80

None Minor Moderateor Severe

Number of Falls

Fall Prevention (84 falls)

Health Education (119 falls)

0

1

2

3

4

5

6

7

8

9

FallPrevention

HealthEducation

Number of Falls

Number of Falls Resulting in Peripheral Fractures

Severity of Injury

Model Predicting Efficacy of the Fall Prevention

Program (Negative Binomial Regression) Variable Incidence Rate Ratio

(95% Confidence Interval)

Fall prevention group assignment 0.65 (0.46-0.94)*

Age 0.96 (0.93-1.00)*

Number of falls in past year 1.31 (1.07-1.61)**

Weekly urinary incontinence 2.51 (1.12-5.66)*

Number of prescription drugs associated with fall risk

1.26 (1.07-1.47)*

Education, high school and below 0.66 (0.45-0.96)*

Cardiovascular disease 0.48 (0.30-0.76)**

Severe hearing loss 1.51 (0.98-2.34)

Poor visual acuity 2.33 (1.00-5.42)*

Past stroke requiring hospitalization 2.85 (1.33-6.08)*

*P < .05**P < .01


Conclusions• In a population-based sample of at-risk older

women, a home program involving simple exercise, education, and tailored risk reduction counseling was effective in reducing falls

• Falls were reduced by 35%

• This program also led to fewer major injuries, although the significance of this finding was influenced by low power

• Results indicate that a multifactorial fall prevention program implemented by nurses can be effective in fall prevention


Conclusions• Future research will report on longer-term

outcomes, the cost-effectiveness of the intervention, and the effect of the intervention on other secondary outcomes

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School of Nursing Center for Gerontological Nursing A Randomized Trial of Exercise, Education, and Risk Reduction Counseling to Prevent Falls in a Population-Based