Communication Intervention Physical Activity

Physical Activity Clinical Trial

Official title:

A Communication Intervention for Physical Activity in Underserved Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419093
• Other study ID #: 5K07CA126985
• Secondary ID: 5K07CA126985
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: September 16, 2015
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
United States	Westside Health Services	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of A's used per visit per discussion of physical activity	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	No
Secondary	Patient-centered Communication Constructs	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	No