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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.

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Presentation on theme: "School of Nursing Center for Gerontological Nursing A Randomized Trial of Exercise, Education, and Risk Reduction Counseling to Prevent Falls in a Population-Based."— Presentation transcript:

1 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, RN Cynthia R. Gross, PhD Richard P. DiFabio, PhD, PT Ruth A. Lindquist, PhD, RN Teresa C. McCarthy, MD John A. Nyman, PhD Michael G. Wade, PhD Mary J. Findorff, PhD, RN Joseph A. Konstan, PhD

2 Center for Gerontological Nursing 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

3 Center for Gerontological Nursing Research Team Co-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

4 Center for Gerontological Nursing 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

5 Center for Gerontological Nursing 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

6 Center for Gerontological Nursing 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)

7 Center for Gerontological Nursing 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

8 Center for Gerontological Nursing 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

9 Center for Gerontological Nursing 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

10 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

11 Center for Gerontological Nursing 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

12 Center for Gerontological Nursing 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

13 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 Assessment Complete (n=131) Withdrawals (n=6) Allocated to Health Education (n=135) 12-Week Assessment Complete (n=132) Withdrawals (n=3) 1-Year Assessment Complete (n=127) Withdrawals (n=9) Deaths (n=1) 1-Year Assessment Complete (n=130) Withdrawals (n=4) Deaths (n=1) Study Flow

14 Center for Gerontological Nursing Sample Characteristics (N=272) CharacteristicFall Prevention (N=137) N (%) or M ± SD Health Education (N=135) N (%) or M ±SD Baseline age78.5 ± ±5.9 White133(97.1)135(100) Lives alone68(49.6)65(48.1) ≥ High School Education85(62.0)78(57.8) Income ≥ $20,000/year76(55.5)64(47.4) History of falling in past year52(38.0)54(40.0) # Chronic conditions2.6± ±1.6 # Weekly prescription drugs3.5 ± ±2.6 SF-36 Physical function61.2 ± ±20.9 Very good or excellent self-rated health46(33.6)50(37.0) Geriatric Depression Scale Score1.9 ± ±2.3

15 Center for Gerontological Nursing Sample Characteristics (N=272) CharacteristicFall Prevention (N=137) N(%) or M ± SD Health Education (N=135) N (%) or M ± SD Mini-Mental State Exam Score28.5± ±5.9 Body mass index28.1± ±5.9 Use of assistive device25(18.2)33(24.4) Berg Balance Test48.9± ±5.5 8-foot timed walk (seconds)3.1±1.92.9±1.4 Timed chair elevations (seconds)16.0± ±5.7 Timed Up and Go Test (seconds)13.1± ±4.2 Hip Strength130.9± ±43.3

16 Center for Gerontological Nursing Fall Frequency at 1 Year

17 Center for Gerontological Nursing Fall Outcomes Over 1-Year OutcomeFall Prevention (N=131) Health Education (N=132) Number of falls84119 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 ± ± * Includes moderate and severe injuries

18 Center for Gerontological Nursing Fall Rate Per 100 Person Years Fall PreventionHealth Education Fall rate per 100 person years* Incidence Rate Ratio: (95% CI: ) *P <.01

19 Center for Gerontological Nursing Type of Injury Number of Falls Resulting in Peripheral Fractures Severity of Injury

20 Model Predicting Efficacy of the Fall Prevention Program (Negative Binomial Regression) VariableIncidence Rate Ratio (95% Confidence Interval) Fall prevention group assignment0.65 ( )* Age0.96 ( )* Number of falls in past year1.31 ( )** Weekly urinary incontinence2.51 ( )* Number of prescription drugs associated with fall risk 1.26 ( )* Education, high school and below0.66 ( )* Cardiovascular disease0.48 ( )** Severe hearing loss1.51 ( ) Poor visual acuity2.33 ( )* Past stroke requiring hospitalization2.85 ( )* *P <.05 **P <.01

21 Center for Gerontological Nursing 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

22 Center for Gerontological Nursing 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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