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Completed

NCT Number: NCT01419093

Communication Intervention Physical Activity

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westside Health Services

Rochester, New York, 14608, United States

About this study

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.]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5 A communication intervention

Other

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 names: ethnically diverse physical activity clinician communication

Primary outcomes

  1. Number of A's used per visit per discussion of physical activity

    Time frame: 5 years

    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 outcomes

  1. Patient-centered Communication Constructs

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Communication Intervention for Physical Activity in Underserved Communities

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2011
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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