Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: December 2013
Estimated Primary Completion Date: December 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419093

Locations
United States, New York
Westside Health Services
Rochester, New York, United States, 14608
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jennifer Carroll, MD, MPH University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: November 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Physical Activity
Exercise

ClinicalTrials.gov processed this record on November 23, 2014