NCT00273806

Brief Summary

The purpose of the study is to determine whether a program of screening and intervention for four health risk behaviors (smoking, problem drinking, sedentary lifestyle, unhealthy diet) carried out by medical assistants in primary care practices can help patients improve their behaviors. The hypothesis is that patients who receive the intervention will demonstrate higher rates of health behavior change than patients who receive usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
864

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

6 active sites

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

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 27, 2008

Status Verified

August 1, 2008

Enrollment Period

1.4 years

First QC Date

January 4, 2006

Last Update Submit

August 26, 2008

Conditions

Keywords

Behavioral risk factorsPrimary CareHealth services research

Outcome Measures

Primary Outcomes (1)

  • Proportion of intervention-group vs. control group patients with behavioral risks at follow-up (individual behaviors separately and combined behaviors).

Secondary Outcomes (6)

  • Total number of health risks identified and interventions ordered by medical assistants (measure program impact).

  • Rate of behavioral risks identified by MA's (risks identified/patients assessed).

  • Rate of interventions ordered by MA's (interventions ordered/patients assessed).

  • Time-motion impact of intervention on medical assistants.

  • Impact on MA satisfaction (qualitative interviews).

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Medical assistant identification and referral for behavioral risk factors.

Behavioral: Intervention for 4 behavioral risks by medical assistants.

2

NO INTERVENTION

Usual care for behavioral risk factors.

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or over
  • Uninsured, enrolled in Bexar County CareLink program
  • Has completed baseline Health Risk Assessment

You may not qualify if:

  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Center for Community Health

San Antonio, Texas, 78207, United States

Location

University Health Center Downtown

San Antonio, Texas, 78207, United States

Location

University Health Center North

San Antonio, Texas, 78216, United States

Location

University Health Center Southeast

San Antonio, Texas, 78223, United States

Location

University Physicians Group - Diagnostic Pavilion

San Antonio, Texas, 78229, United States

Location

University Health Center Southwest

San Antonio, Texas, 78237, United States

Location

Related Links

MeSH Terms

Conditions

SmokingAlcoholismSedentary Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

BehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Robert L Ferrer, MD, MPH

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

December 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 27, 2008

Record last verified: 2008-08

Locations