Substance Use DisordersSevaNCT01963234

Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)

A study testing Seva in people with Substance Use Disorders and HIV, run by University of Wisconsin, Madison at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Implementing a mobile-phone based system for drug use disorders in primary care settings. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Substance Use Disorders, HIV
What is being tested?: Seva
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 439 participants
Where: 3 sitesUnited States
Study dates: Mar 2014to 30 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

Failure to meet inclusion criteria above will exclude patients and clinicians from participating.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

UW Health Access Clinic
Madison, Wisconsin, 53706
Partnership Health Center
Missoula, Montana
Institute for Family Health
The Bronx, New York

Other trials in United States

About this study

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

Read the detailed description

The purpose of the research is to study the impact of a recovery support system called Seva on primary care organizations, where issues such as coordination of care, job satisfaction, and the cost of adopting and operating new technologies are critical. The study will also investigate how to best implement this kind of technology into health care delivery systems that care for people diagnosed with substance abuse.

Conditions: Substance Use Disorders, HIV
Being tested: Seva
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SevaBehavioural
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.

Study groups in NCT01963234
Study group	Role	What they receive
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. Receives: Behavioral: Seva

What is being measured

The primary outcome is the main question the study is designed to answer.

Implementation Status
The number of implementation milestones completed
Measured: up to 3 years
Any Drinking Days in Last 30 Days
Measured: 6 months
Risky Drinking Days in the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Measured: 6 months
Illicit Drug-use Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Patient Had Any Drink Within the Last 30 Days
Analysis for measure was done for the total of all three sites combined.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months

Secondary outcomes (3)

Number of Patients Using System
Analysis for measure was done for the total of all three sites combined.
Measured: up to 3 years
Clinical Adoption
We analyzed computerized system log files to produce patterns of system adoption of the staff.
Measured: up to 3 years
Total Costs for Clinic
This includes the clinic operating costs and clinic implementation costs of the intervention.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201430 Jun 2017

First posted16 Oct 2013 (estimated)
Study startMar 2014
Primary completion30 Jun 2017
Study completion30 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Substance Use DisordersStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 439 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01963234
Sponsor's protocol ID: 2012-0937
Other IDs: R01DA034279-01
Acronym: Seva
Status last verified: Jul 2018
First submitted: 9 Oct 2013
Last updated: 31 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 31237841
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.
PubMed 27687632
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.
PubMed 24884976

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
ClinicalTrials.gov ID: NCT01963234
Acronym / sponsor ID: Seva / 2012-0937
Conditions: Substance Use Disorders, HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 439 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Dartmouth College, Center for Health Enhancement System Studies
Study start: Mar 2014 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2017 (actual)
First posted: 16 Oct 2013 (estimated)
Results: Posted 31 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Seva	Experimental	Behavioral: SevaUp to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

Failure to meet inclusion criteria above will exclude patients and clinicians from participating.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SevaPatients 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.	Behavioural	Seva

Primary outcome

Implementation Status
Time frame: up to 3 years
The number of implementation milestones completed
Any Drinking Days in Last 30 Days
Time frame: 6 months
Risky Drinking Days in the Last 30 Days
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Illicit Drug-use Within the Last 30 Days
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Overall Quality of Life
Time frame: 6 months
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.
Physical Subscale Quality of Life
Time frame: 6 months
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.
Mental Subscale Quality of Life
Time frame: 6 months
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.
Patient Had Any Drink Within the Last 30 Days
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Patient Had Illicit Drug Use Within the Last 30 Days
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Patient Had Any Drink or Drug Use Within the Last 30 Days
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Patients, Within the Last 6 Months Have Received Other Addiction Treatment
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Patients Partook in HIV Risky Behavior in the Last 6 Months
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.
Patients Partook in HIV Testing in the Last 6 Months
Time frame: 6 months
Analysis for measure was done for the total of all three sites combined.

3 secondary outcomes

Number of Patients Using System
Time frame: up to 3 years
Clinical Adoption
Time frame: up to 3 years
Total Costs for Clinic
Time frame: 6 months

Results and safety

Results posted to the registry on 31 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Seva - Patients	268	207
Seva - Clinicians	171	171

Primary outcome: Implementation Status

Time frame: up to 3 years. Number. Unit: milestones

Measure	Seva - Madison Site n = 72	Seva - Missoula n = 74	Seva - Bronx n = 61
Value	12	12	12

Population analysed: These are milestones achieved for each site.

Primary outcome: Any Drinking Days in Last 30 Days

Time frame: 6 months. Mean (Standard Deviation). Unit: days

Measure	Seva n = 207
Value	1.67 (4.69)

Population analysed: Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.

Primary outcome: Risky Drinking Days in the Last 30 Days

Time frame: 6 months. Mean (Standard Deviation). Unit: days

Measure	Seva n = 207
Value	0.70 (2.58)

Primary outcome: Illicit Drug-use Within the Last 30 Days

Time frame: 6 months. Mean (Standard Deviation). Unit: days

Measure	Seva n = 206
Value	2.14 (6.55)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Seva - Patients	3 of 268 (1.1%)	0 of 268 (0%)	3 of 268
Seva - Clinicians	0 of 171 (0%)	0 of 171 (0%)	0 of 171

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31237841Quanbeck 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.
Derived from this study: PubMed 27687632Mares 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.
Derived from this study: PubMed 24884976Quanbeck 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Seva in people with Substance Use Disorders and HIV, run by University of Wisconsin, Madison at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation Status (time frame: up to 3 years). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01963234, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.