The Total Health Study

Risk Reduction Behavior Clinical Trial

Official title:

Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415206
• Other study ID #: 10-01298
• Secondary ID: P50DA009253
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 21, 2016

Study information

• Verified date: July 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 21, 2016
• Est. primary completion date: June 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Risk Reduction Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client engagement with behavior change service referrals		Up to18 months follow-up.
Secondary	Behavioral changes in multiple risks		up to 18 months follow-up.
Secondary	Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up.		up to 18 months follow-up.