Clinical trial NCT01419093: Communication Intervention Physical Activity
Official title: A Communication Intervention for Physical Activity in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical Activity
Exercise
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-17
Enrollment: 325
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Number of A's used per visit per discussion of physical activity
timeFrame: 5 years
Secondary outcomes:
measure: Patient-centered Communication Constructs
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Westside Health Services
state: New York
Study officials:
affiliation: University of Rochester
name: Jennifer Carroll, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.