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
  Purpose

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.


Condition Intervention
Risk Reduction Behavior
Behavioral: Extended Staging Health Risk Intervention (S-HRI)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Extended Care Treatment of Multiple Risk Behaviors in Complex Patients

Further study details as provided by University of California, San Francisco:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 250
Study Start Date: August 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415206

Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Judith J Prochaska, PhD, MPH Stanford University
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01415206     History of Changes
Other Study ID Numbers: 10-01298, P50 DA009253
Study First Received: August 9, 2011
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Behavioral changes
Multiple risks

ClinicalTrials.gov processed this record on September 22, 2014