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Communication Intervention Physical Activity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01419093
First received: August 10, 2011
Last updated: November 5, 2013
Last verified: November 2013

August 10, 2011
November 5, 2013
September 2008
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01419093 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Communication Intervention Physical Activity
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.

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.]

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
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
No Intervention: 5A Communication
Behavioral: 5 A intervention for physical activity
Intervention: Other: 5 A communication intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
371
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01419093
5K07CA126985, 5K07CA126985
No
University of Rochester
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Jennifer Carroll, MD, MPH University of Rochester
University of Rochester
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP