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

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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

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Acknowledgments

• National Institute of Nursing Research and Office
  of Womens Health Research, National Institutes
  of Health (R01 NR05107)
• School of Nursing, University of Minnesota

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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

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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

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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

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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)

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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

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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
• Lubbens 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

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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

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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

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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

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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

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Study Flow
Assessed for eligibility (N4112)
Excluded (n3840) Non response (n1332) Ineligible
(n1200) Refused (n965) Other (n343)
Eligible and Randomized (N272)
Allocated to Fall Prevention (n137)
Allocated to Health Education (n135)
12-Week Assessment Complete (n131) Withdrawals
(n6)
12-Week Assessment Complete (n132) Withdrawals
(n3)
1-Year Assessment Complete (n127) Withdrawals
(n9) Deaths (n1)
1-Year Assessment Complete (n130) Withdrawals
(n4) Deaths (n1)
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Sample Characteristics (N272)
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Sample Characteristics (N272)
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Fall Frequency at 1 Year
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Fall Outcomes Over 1-Year
Includes moderate and severe injuries
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Fall Rate Per 100 Person Years
P Incidence Rate Ratio 0.717 (95 CI
0.535-0.955)
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Type of Injury
Severity of Injury
Number of Falls Resulting in Peripheral Fractures
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Model Predicting Efficacy of the Fall Prevention
Program (Negative Binomial Regression)
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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

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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