- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419093
Communication Intervention Physical Activity
September 16, 2015 updated by: University of Rochester
A Communication Intervention for Physical Activity in Underserved Communities
The project is a two-arm randomized clinical trial to pilot the feasibility of a communication training intervention for primary care clinicians, linked to a community program referral, on use of the 5As to promote physical activity in underserved patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will focus on training clinicians to communicate effectively using the 5As and patient-centered communication skills (Aim 1).
When implemented fully, the intervention will also include referral to a community fitness program.
Clinicians will be randomly assigned to two groups (1 and 2).
Group 1 will participate in the training intervention first; group 2 will act as a wait-list control for Group 1.
The primary outcome, the effectiveness of the intervention on clinician use of the 5As during routine office visits, will be measured by examining 371 audio-recorded patient visits prior to, immediately, after, and 6 months after the clinician is trained.
Secondary outcomes include whether the communication training intervention improved patients' perceived competence to adopt physical activity (Aim 2)and whether clinicians believe that the communication intervention addressed pertinent barriers to promoting exercise (Aim 3).
Exploratory outcomes (Aim 4) will [assess potential mediators of the intervention's effect, examine the effect of the intervention on actual physical activity levels in a subset of participants, and create a taxonomy of communication markers for each of the 5As.]
Study Type
Interventional
Enrollment (Actual)
325
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Rochester, New York, United States, 14608
- Westside Health Services
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current patients at Westside Health Services
- Be scheduled for a routine, follow-up or health maintenance office visit
- Be practicing clinicians (physicians, physician asst. or nurse practitioner
Exclusion Criteria:
- Have life-threatening acute medical problem which precludes participation
- Unable to read and understand English
- Already achieving recommended level of physical activity
- Planning to move or relocate (clinicians) to another practice in the study period
- Serving as study investigators, consultants, or advisors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 5A Communication
Behavioral: 5 A intervention for physical activity
|
This study will examine the effect of primary care clinicians' communication intervention linked to a community-based exercise program.
We will use the 5As in discussion of physical activity in 371 office visits in an ethnically diverse, primarily low income patient population.
Secondary and exploratory aims are to provide pilot information on [feasibility and sustainability of the intervention from the patients' and clinicians' perspective and derive effect sizes on the intervention's effect on objective changes in physical activity in a subset of participants.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of A's used per visit per discussion of physical activity
Time Frame: 5 years
|
The mean 5A Score of patients from clinicians who complete the communicatin interventon will be higher thant the mean 5A Score of patients from physicisns that have not been trained.
Analytic plan: Unadjusted analysis will use two-sample t-tests to compare means.
Adjusted analyses will use linear mixed effects models as described in the Statistical Analysis section.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-centered Communication Constructs
Time Frame: 5 years
|
Patient survey; fifteen items.Assesses patient perceptions of providers' being autonomy supportive versus controlling.
Measures participants' feelings of competence at carrying out a treament regimen.
Scored by trained coder listening to audiorecorded visits.
Clinicians survey; 20 items such as whether the clinician would recmmend the intervention to other clinicians.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Carroll, MD, MPH, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carroll JK, Winters PC, Sanders MR, Decker F, Ngo T, Sciamanna CN. Clinician-targeted intervention and patient-reported counseling on physical activity. Prev Chronic Dis. 2014 May 29;11:E89. doi: 10.5888/pcd11.130302.
- Carroll JK, Fiscella K, Epstein RM, Sanders MR, Winters PC, Moorhead SA, van Osch L, Williams GC. Physical activity counseling intervention at a federally qualified health center: improves autonomy-supportiveness, but not patients' perceived competence. Patient Educ Couns. 2013 Sep;92(3):432-6. doi: 10.1016/j.pec.2013.06.031. Epub 2013 Aug 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 16, 2011
First Posted (Estimate)
August 17, 2011
Study Record Updates
Last Update Posted (Estimate)
September 18, 2015
Last Update Submitted That Met QC Criteria
September 16, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5K07CA126985 (U.S. NIH Grant/Contract)
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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-
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-
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