The Total Health Study

Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

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.

Study Overview

• Status: Completed
• Conditions: Risk Reduction Behavior
• Intervention / Treatment: Behavioral: Extended Staging Health Risk Intervention (S-HRI); Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Other: 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.	Behavioral: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Judith J Prochaska, PhD, MPH, Stanford University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 2, 2015
• Study Completion (Actual): June 21, 2016

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Behavioral changes; Multiple risks
• Other Study ID Numbers: 10-01298; P50DA009253 (U.S. NIH Grant/Contract)