Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Total Health Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01415206
First received: August 9, 2011
Last updated: May 5, 2014
Last verified: May 2014

August 9, 2011
May 5, 2014
August 2011
April 2013   (final data collection date for primary outcome measure)
Client engagement with behavior change service referrals [ Time Frame: Up to18 months follow-up. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01415206 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Risk Reduction Behavior
  • 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.
  • 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.
    Intervention: Behavioral: Extended Staging Health Risk Intervention (S-HRI)
  • 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.
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
October 2015
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01415206
10-01298, P50 DA009253
Yes
University of California, San Francisco
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Principal Investigator: Judith J Prochaska, PhD, MPH Stanford University
University of California, San Francisco
May 2014

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