NCT01963234

Brief Summary

Implementing a mobile-phone based system for drug use disorders in primary care settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

October 9, 2013

Results QC Date

February 28, 2018

Last Update Submit

July 3, 2018

Conditions

Substance Use DisordersHIV

Outcome Measures

Primary Outcomes (13)

  • Implementation Status

    The number of implementation milestones completed

    up to 3 years

  • Any Drinking Days in Last 30 Days

    6 months

  • Risky Drinking Days in the Last 30 Days

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Illicit Drug-use Within the Last 30 Days

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Overall Quality of Life

    Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40.

    6 months

  • Physical Subscale Quality of Life

    Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20.

    6 months

  • Mental Subscale Quality of Life

    Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20.

    6 months

  • Patient Had Any Drink Within the Last 30 Days

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Patient Had Illicit Drug Use Within the Last 30 Days

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Patient Had Any Drink or Drug Use Within the Last 30 Days

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Patients, Within the Last 6 Months Have Received Other Addiction Treatment

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Patients Partook in HIV Risky Behavior in the Last 6 Months

    Analysis for measure was done for the total of all three sites combined.

    6 months

  • Patients Partook in HIV Testing in the Last 6 Months

    Analysis for measure was done for the total of all three sites combined.

    6 months

Secondary Outcomes (3)

  • Number of Patients Using System

    up to 3 years

  • Clinical Adoption

    up to 3 years

  • Total Costs for Clinic

    6 months

Study Arms (1)

Seva

EXPERIMENTAL

Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.

Behavioral: Seva

Interventions

SevaBEHAVIORAL

Patients were given access to use Seva. This is a mobile application that uses social and behavioral theories to help support people after alcohol use disorder recovery.

Seva

Eligibility Criteria

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

You may qualify if:

  • Patient subjects must be 1) age 18 or older 2) meet criteria for Substance Use Disorder (SUD) according to the clinic. Clinician subjects referring patients will ensure that patients: 3) have no current psychotic disorder severe enough to prevent participation, 4) have no acute medical problem requiring immediate inpatient treatment, 5) are willing to use Seva, and 6) can understand and sign a consent form in English.
  • Clinician subjects include MDs, behavioral health providers, nurses and management staff from the clinics' primary care and behavioral health departments. Clinician must have an interest in the research objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Partnership Health Center

Missoula, Montana, United States

Location

Institute for Family Health

The Bronx, New York, United States

Location

UW Health Access Clinic

Madison, Wisconsin, 53706, United States

Location

Related Publications (3)

  • Quanbeck A. Using Stakeholder Values to Promote Implementation of an Evidence-Based Mobile Health Intervention for Addiction Treatment in Primary Care Settings. JMIR Mhealth Uhealth. 2019 Jun 7;7(6):e13301. doi: 10.2196/13301.

    PMID: 31237841DERIVED

  • Mares ML, Gustafson DH, Glass JE, Quanbeck A, McDowell H, McTavish F, Atwood AK, Marsch LA, Thomas C, Shah D, Brown R, Isham A, Nealon MJ, Ward V. Implementing an mHealth system for substance use disorders in primary care: a mixed methods study of clinicians' initial expectations and first year experiences. BMC Med Inform Decis Mak. 2016 Sep 29;16(1):126. doi: 10.1186/s12911-016-0365-5.

    PMID: 27687632DERIVED

  • Quanbeck AR, Gustafson DH, Marsch LA, McTavish F, Brown RT, Mares ML, Johnson R, Glass JE, Atwood AK, McDowell H. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study. Implement Sci. 2014 May 29;9:65. doi: 10.1186/1748-5908-9-65.

    PMID: 24884976DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Andrew Quanbeck
Organization
University of Wisconsin - Madison
arquanbe@wisc.edu
6082627385

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 16, 2013

Study Start

March 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 31, 2018

Results First Posted

July 31, 2018

Record last verified: 2018-07

Locations

US(3)