The Total Health Study

Not Applicable

Completed

• Conditions: Risk Reduction Behavior
• Interventions: Behavioral: Extended Staging Health Risk Intervention (S-HRI); Behavioral: Usual Care

• Registration Number: NCT01415206
• Lead Sponsor: University of California, San Francisco

Brief Summary

This study is a randomized, controlled, multiple risk intervention pilot study evaluated with clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over 12-months time.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2015-06-02
• Study Completion: 2016-06-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Inclusion criteria are: at least 18 years of age, enrolled in the San Francisco Veteran Affairs Medical Center (SF VAMC) Substance Abuse Programs, residing in the San Francisco Bay Area and not planning to relocate out of the area in the next 18 months. For patients in the Day Hospital, we will wait until they have completed one week of treatment before approaching for study involvement, as the first week is the most intensive for services.

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Exclusion Criteria

• Exclusion criteria are: unstable psychiatric disorder and severe cognitive impairment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended Staging Health Risk Intervention (S-HRI)	Extended Staging Health Risk Intervention (S-HRI)	The S-HRI provides feedback on participants' stages of change for each risk and the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (MI) coaching and referrals to relevant behavior change services. Repeated computer and individual counseling contacts at baseline, 3, 6 and 12 months follow-up are designed to support participants through the process of changing multiple risk behaviors.
Usual Care	Usual Care	Participants in the usual care condition will complete the core assessments and the Staging Health Risk Assessment (S-HRA) online at baseline, 3, 6, 12, and 18 months follow-up but will not meet with the study MI coach and will NOT receive any feedback or printed report until the 18-month follow-up.

Primary Outcome Measures

Name	Time	Method
Client engagement with behavior change service referrals	Up to18 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Behavioral changes in multiple risks	up to 18 months follow-up.
Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up.	up to 18 months follow-up.

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States