The Total Health Study

Study Overview
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Brief Summary
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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.

Official Title
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Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

Conditions
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Risk Reduction Behavior

Intervention / Treatment
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* Behavioral: Extended Staging Health Risk Intervention (S-HRI)
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Exclusion criteria are: unstable psychiatric disorder and severe cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Staging Health Risk Intervention (S-HRI)<br>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. | Behavioral: Extended Staging Health Risk Intervention (S-HRI)<br>* 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.<br>|
| Other: Usual Care<br>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. | Behavioral: Usual Care<br>* Participants in the usual care condition will complete the core assessments and the 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client engagement with behavior change service referrals |  | Up to18 months follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral changes, Multiple risks