Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program

Study Overview
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Brief Summary
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Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.

Detailed Description
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This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk. This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.

Official Title
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Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program

Conditions
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Lower Extremity Weakness Distal, Distorted; Balance

Intervention / Treatment
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* Behavioral: Assessment and education
* Behavioral: Healthy Steps with Falls Case Management
* Behavioral: Healthy Steps in Motion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent Willing to be randomized Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery Age 50+ Exclusion Criteria: Hospice enrollee or life-threatening illness Active cancer treatment Neurologic disease linked to falls risk, such as Parkinson's Unable to ambulate indoors High likelihood of moving in next 6 months

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Steps<br>Healthy Steps program as currently implemented by the PA Department of Aging | Behavioral: Assessment and education<br>* PA Healthy Steps program<br>|
| Experimental: Healthy Steps with Falls Case Management<br>Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment | Behavioral: Healthy Steps with Falls Case Management<br>* Counseling to ensure that participants receive a physician assessment and home safety check<br>|
| Experimental: Healthy Steps in Motion<br>Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise. | Behavioral: Healthy Steps in Motion<br>* Group exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Falls ascertained in automated monthly telephone contact | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall-related injuries requiring hospitalization/emergency department care | Events ascertained in a monthly automated telephone interview | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, exercise, safety, injury, Older adults