NCT01415206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2016

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

August 9, 2011

Last Update Submit

July 11, 2019

Conditions

Risk Reduction Behavior

Keywords

Behavioral changesMultiple risks

Outcome Measures

Primary Outcomes (1)

  • Client engagement with behavior change service referrals

    Up to18 months follow-up.

Secondary Outcomes (2)

  • 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.

Study Arms (2)

Extended Staging Health Risk Intervention (S-HRI)

EXPERIMENTAL

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)

Usual Care

OTHER

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

Interventions

Extended Staging Health Risk Intervention (S-HRI)BEHAVIORAL

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.

Extended Staging Health Risk Intervention (S-HRI)
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Judith J Prochaska, PhD, MPH

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

June 2, 2015

Study Completion

June 21, 2016

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

US(1)