NCT01419093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

5.3 years

First QC Date

August 10, 2011

Last Update Submit

September 16, 2015

Conditions

Physical Activity

Keywords

Physical ActivityExercise

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient-centered Communication Constructs

    5 years

Study Arms (1)

5A Communication

NO INTERVENTION

Behavioral: 5 A intervention for physical activity

Other: 5 A communication intervention

Interventions

5 A communication interventionOTHER

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.

Also known as: ethnically diverse physical activity clinician communication
5A Communication

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westside Health Services

Rochester, New York, 14608, United States

Location

Related Publications (2)

  • 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.

    PMID: 24874781DERIVED

  • 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.

    PMID: 23932756DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Carroll, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 17, 2011

Study Start

September 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

US(1)