Communication Intervention Physical Activity
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Physical Activity |
Other: 5 A communication intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Communication Intervention for Physical Activity in Underserved Communities |
- Number of A's used per visit per discussion of physical activity [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Patient-centered Communication Constructs [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 371 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 5A Communication
Behavioral: 5 A intervention for physical activity
|
Other: 5 A communication intervention
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 Name: ethnically diverse physical activity clinician communication
|
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.]
Eligibility| Ages Eligible for Study: | 30 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jennifer Carroll, MD, MPH | 585-506-9484 ext 219 | jennifer_carroll@urmc.rochester.edu |
| Contact: Mechelle R Sanders, BA | 585-506-9484 ext 111 | mechelle_sanders@urmc.rochester.edu |
| United States, New York | |
| Westside Health Services | Recruiting |
| Rochester, New York, United States, 14608 | |
| Contact: Jennifer Carroll, MD, MPH jennifer_carroll@urmc.rochester.edu | |
| Contact: Mechelle R Sanders, BA mechelle_sanders@urmc.rochester.edu | |
| Principal Investigator: Jennifer Carroll, MD, MPH | |
| Principal Investigator: | Jennifer Carroll, MD, MPH | University of Rochester |
More Information
No publications provided
| Responsible Party: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01419093 History of Changes |
| Other Study ID Numbers: | 5K07CA126985, 5K07CA126985 |
| Study First Received: | August 10, 2011 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rochester:
|
Physical Activity Exercise |
ClinicalTrials.gov processed this record on May 23, 2013