- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139461
Physical Therapists - Recommending EnhanceFitness to Expand Reach (PT-REFER)
Promoting Healthy Aging by Scaling Up What Works
The goal of the study is to develop and test an intervention toolkit to increase the enrollment in EnhanceFitness (an evidence-based group physical activity program for older adults) at Young Men Christian Association (YMCA) sites through physical therapist referrals.
A cluster-randomized trial will be used to compare current and intervention toolkit approaches to generating enrollment in EnhanceFitness at YMCAs. The objective of this trial is to compare the effectiveness and cost of the current approach for generating enrollment in EnhanceFitness ("business as usual" or "control arm") with the intervention toolkit that YMCA staff will use to engage physical therapists to refer their older adult patients to EnhanceFitness (the "intervention").
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the greatest challenges the public health community faces is increasing the adoption of evidence-based, health-promoting behaviors and practices. This is particularly true in the areas of chronic disease prevention and healthy aging. Of the 10 leading health indicators for Healthy People 2020, five are related to healthy aging (immunization, maintaining a healthy weight, mental health, physical activity, and avoiding tobacco use) and can be improved through participation in evidence-based programs.
Enhance®Fitness (EF) is a community-based physical-activity program that has demonstrated physical, social and emotional benefits for older adults and is recommended by the Centers for Disease Control and Prevention (CDC) Arthritis Program. In 2012, YMCA of the USA (Y-USA) made delivery of EF to older adults one of its highest strategic priorities. Y-USA is currently implementing EF at YMCAs in 22 states, with plans to continue expanding the program throughout its national network.
Older adults value provider recommendations of community-based programs like EF and are much more likely to participate if a provider recommends that they do so. Previous studies show that primary-care providers (such as physicians and nurses) are eager to find effective physical-activity programs for older patients and willing to recommend these programs. Much less is known about how to facilitate recommendations by physical therapists, who have frequent and intensive contact with older adults, and may be better positioned to make referrals to physical activity programs than primary care providers due to longer appointment times and other factors.
The goal of the study is to develop and test an intervention toolkit to increase the enrollment in EF YMCA sites through physical therapist referrals. The investigators conducted interviews with YMCA staff who manage the delivery of EF in their associations. The objective of these interviews with YMCA staff was to inform the content of the intervention toolkit. The interviews focused on the YMCA staff members' experience with evidence-based programs, their current provider outreach approaches and sites, and their beliefs about what they hope to get out of increased referrals for EF from physical therapists. Similar interviews were conducted with physical therapists across the country to gather data about components of referral practices, attitudes regarding recommending EF, and the logistics of how YMCA associations can best work with providers across the country to disseminate information about EF.
The investigators used this information to develop the intervention, which consists of a toolkit for YMCA staff to use to engage physical therapists to refer their suitable clients to EF at a YMCA. A cluster-randomized trial will be used to compare the effectiveness and cost for generating enrollment in EF of the current approach ("business as usual" or "control arm") and the intervention toolkit that YMCA staff will use to engage physical therapists to refer their older adult patients to EF (the "intervention").
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- Health Promotion Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible YMCA Associations are those that (1) currently operate one or more EF class, either in a YMCA branch or in a community setting, and (2) have two or more YMCA branches within their YMCA Association.
Exclusion Criteria:
- YMCA Associations not offering EF with actively enrolled participants and active classes as of November 2014 are not eligible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Receives PT-REFER Capacity-building toolkit to facilitate partnership building with physical therapists
|
|
No Intervention: Control
Does not receive PT-REFER Capacity-building toolkit to guide partnership building, instead conducting business as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EF Enrollment
Time Frame: 2 years
|
Number of older adults that enroll in EF at YMCAs
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Communications tracking
Time Frame: 2 years
|
Spreadsheet of YMCA Association communications (e.g., letters, emails, visits, and talks)
|
2 years
|
Staff time
Time Frame: 2 years
|
Online survey tracking the staff time associated with the enhanced approach, including time spent outreaching to physical therapists, and time to prepare and distribute materials.
|
2 years
|
Distribution of Marketing Materials
Time Frame: 2 years
|
Spreadsheet of YMCA Associations to track distribution of marketing materials to providers
|
2 years
|
Provider recruitment practices
Time Frame: 1 year and 2 years
|
Online survey of current practices
|
1 year and 2 years
|
PT Referred EF Enrollment
Time Frame: 2 years
|
Number of older adults that enroll in EF at YMCAs after referral from a physical therapist (PT)
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miruna Petrescu-Prahova, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001659
- U48DP005013 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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