The Total Health Study

This study is currently recruiting participants.

Verified October 2012 by University of California, San Francisco

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01415206

First received: August 9, 2011

Last updated: October 14, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

October 14, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Client engagement with behavior change service referrals [ Time Frame: Up to18 months follow-up. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01415206 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Behavioral changes in multiple risks [ Time Frame: up to 18 months follow-up. ] [ Designated as safety issue: No ]
Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up. [ Time Frame: up to 18 months follow-up. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Behavioral changes in multiple risks [ Time Frame: 3, 6, 12, and 18 months follow-up. ] [ Designated as safety issue: No ]
Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up. [ Time Frame: 3, 6, 12, and 18 months follow-up. ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Total Health Study

Official Title ^ICMJE

Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Risk Reduction Behavior

Intervention ^ICMJE

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.
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.

Study Arm (s)

Experimental: Extended Staging Health Risk Intervention (S-HRI)
Intervention: Behavioral: Extended Staging Health Risk Intervention (S-HRI)
Usual Care
Intervention: Behavioral: Usual Care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Completion Date

Not Provided

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Inclusion criteria are: at least 18 years of age, enrolled in the 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01415206

Other Study ID Numbers ^ICMJE

10-01298

Has Data Monitoring Committee

Yes

Responsible Party

University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Judith J Prochaska, PhD, MPH

University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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