Physical ActivityPT-REFERNCT03139461
Physical Therapists - Recommending EnhanceFitness to Expand Reach
A study testing PT-REFER Capacity-building Toolkit in people with Physical Activity and Aging, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physical Activity, Aging
- What is being tested?
- PT-REFER Capacity-building Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- YMCA Associations not offering EF with actively enrolled participants and active classes as of November 2014 are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Promotion Research Center
Seattle, Washington, 98105
About this study
Official title: 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").
Read the 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").
- Conditions
- Physical Activity, Aging
- Being tested
- PT-REFER Capacity-building Toolkit
- Keywords
- Physical Therapy, Capacity Building, Clinical-Community Linkages
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-REFER Capacity-building ToolkitOther
- Written guidelines for building partnerships with physical therapists. Information includes information on who to contact, how to contact them, and how to present information about the program (e.g., evidence base, program structure)
- Support from Change Agent
- Technical Assistance Calls
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receives PT-REFER Capacity-building toolkit to facilitate partnership building with physical therapists Receives: Other: PT-REFER Capacity-building Toolkit |
| Control | No intervention | Does not receive PT-REFER Capacity-building toolkit to guide partnership building, instead conducting business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EF Enrollment
Number of older adults that enroll in EF at YMCAs
Measured: 2 years
Secondary outcomes (5)
Communications tracking
Spreadsheet of YMCA Association communications (e.g., letters, emails, visits, and talks)
Measured: 2 years
Staff time
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.
Measured: 2 years
Distribution of Marketing Materials
Spreadsheet of YMCA Associations to track distribution of marketing materials to providers
Measured: 2 years
Provider recruitment practices
Online survey of current practices
Measured: 1 year and 2 years
PT Referred EF Enrollment
Number of older adults that enroll in EF at YMCAs after referral from a physical therapist (PT)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startJan 2015
- Primary completionSep 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, YMCA
- Responsible party
- Principal investigator, Miruna Petrescu-Prahova, University of Washington
- Investigators
- Miruna Petrescu-Prahova, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139461
- Sponsor's protocol ID
- STUDY00001659
- Other IDs
- U48DP005013
- Acronym
- PT-REFER
- Status last verified
- Feb 2020
- First submitted
- 26 Apr 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Aging by Scaling Up What Works
- ClinicalTrials.gov ID
- NCT03139461
- Acronym / sponsor ID
- PT-REFER / STUDY00001659
- Conditions
- Physical Activity, Aging
- Keywords
- Physical Therapy, Capacity Building, Clinical-Community Linkages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, YMCA
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: PT-REFER Capacity-building ToolkitReceives PT-REFER Capacity-building toolkit to facilitate partnership building with physical therapists |
| Control | No intervention | –Does not receive PT-REFER Capacity-building toolkit to guide partnership building, instead conducting business as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- YMCA Associations not offering EF with actively enrolled participants and active classes as of November 2014 are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT-REFER Capacity-building Toolkit1. Written guidelines for building partnerships with physical therapists. Information includes information on who to contact, how to contact them, and how to present information about the program (e.g., evidence base, program structure) 2. Support from Change Agent 3. Technical Assistance Calls | Other | Intervention |
Primary outcome
EF Enrollment
Time frame: 2 years
Number of older adults that enroll in EF at YMCAs
5 secondary outcomes
Communications tracking
Time frame: 2 years
Staff time
Time frame: 2 years
Distribution of Marketing Materials
Time frame: 2 years
Provider recruitment practices
Time frame: 1 year and 2 years
PT Referred EF Enrollment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miruna Petrescu-Prahova, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT-REFER Capacity-building Toolkit in people with Physical Activity and Aging, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EF Enrollment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.