Substance Use DisordersNCT04162132
Contingency Management Using Smartphone App in Patients With SUD
An observational study of Substance Use Disorders, run by BrightView LLC at 1 site in United States.
Trial summary
The purpose of this research study is to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Smartphone app
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 29 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study focused on a population of 108 adult patients with a primary diagnosis of substance use disorder who were enrolled at a BrightView outpatient treatment center.
Who may be able to join
- >18 years old
- Substance use disorder (SUD) as a primary diagnosis
- Have and use an Android or iOS smartphone with acceptable capability
- Are willing to participate in home testing and use of the smartphone
- Speak and read the English language adequately to understand smartphone commands and responses
- Are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study of Contingency Management Using A Smartphone Application in Patients With Substance Use Disorder
The purpose of this research study is to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView.
Read the detailed description
The purpose of this research study was to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView (www.brightviewhealth.com). Patients performed self-tracking of their recovery behavior (e.g., counseling attendance, abstinence from drugs and alcohol) addiction recovery behavior using the DynamiCare app, which follows Contingency Management (CM) model of incentivizing positive behavior.
CM is shown as a highly effective, evidence-based methodology for improving substance use disorder (SUD) outcomes. It does so by activating the brain's reward and inhibitory systems through both positive and negative reinforcement using immediate, concrete incentives in a progressive reinforcement schedule. CM involves setting frequent (>1/week), objective goals (usually abstinence or participation in treatment), which patients can achieve to earn tangible rewards (such as cash or vouchers). The DynamiCare smart phone app (iOS/Android) uses CM to incentivize patients to attend scheduled appointments and to submit negative alcohol and drug tests as they are rewarded for these behaviors. The intentions of this project were to assess whether use of the smartphone app as an add-on to treatment as usual could increase treatment retention, increase the percentage of appointments that were kept, and if substance use could be reduced for patients using the app.
Patients were enrolled in the study on a rolling basis from Jan 25, 2019 to March 29, 2019 until the desired cohort group # was reached (n=108). The intervention period (period of time when patients actually used the DynamiCare app) lasted four months from the date of their enrollment.
- Conditions
- Substance Use Disorders
- Being tested
- Smartphone app
- Keywords
- contingency management, smartphone app, substance use disorder, outpatient addiction treatment, BrightView, DynamiCare
- 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.
Smartphone appDevice
Study procedures related to the DynamiCare Rewards intervention were conducted via smartphone. Research visits included collection of urine samples and medical exams. Participants assigned to the DynamiCare Rewards group received: 1) the app on their smartphone, 2) drug testing devices when indicated (pocket-sized breathalyzer), and a reloadable debit card for receiving the financial incentives (the PEX debit card). Global Positioning System (GPS) tracking was used to track whether patients had attended their scheduled appointments but was not used at any other times. All information was uploaded from the app onto the DynamiCare Analytics website, which treatment providers could view. The information reported was: attendance status of appointments, the status of all alcohol and drug testing, and incentives earned. Each patient's intervention period (period of time when they used the app) lasted four months from the date of their enrollment.
| Study group | Role | What they receive |
|---|---|---|
| DynamiCare group | Patients at Morgan Street location of BrightView who were given the DynamiCare smartphone app. Receives: Device: Smartphone app | |
| Non-DynamiCare group | Patients at Colerain location of BrightView who were not given the DynamiCare smartphone app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
The DynamiCare smart phone app was used to see whether the percentage of scheduled appointments could be increased by using the app. As measured by % of attendance of medical and clinical appointments compared to controls.
Measured: 4 months
Substance Use
The DynamiCare smart phone app was used to see if use of the app could reduce substance use as measured by urine toxicology results. Measured percentage of patients using the app testing consistent only for prescribed substances in random clinical urine tests compared to controls.
Measured: 4 months
Retention
The DynamiCare smart phone app was used to see if treatment retention could be increased when the app was added to treatment as usual. Measured as the percent of patients who are still active in the DynamiCare app and attending treatment sessions after 1, 2, 3, and 4 months compared to controls.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start25 Jan 2019
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightView LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DynamiCare Health
- Responsible party
- Sponsor
- Investigators
- Shawn Ryan, MD, MBA, Principal investigator, President & CMOSamin Rezania, PhD, Study director, Director of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162132
- Sponsor's protocol ID
- 7135-SRyan
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Contingency Management Using A Smartphone Application in Patients With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT04162132
- Acronym / sponsor ID
- 7135-SRyan
- Conditions
- Substance Use Disorders
- Keywords
- contingency management, smartphone app, substance use disorder, outpatient addiction treatment, BrightView, DynamiCare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- BrightView LLCIndustry (pharma, biotech, devices)
- Collaborators
- DynamiCare Health
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView.
Detailed description
The purpose of this research study was to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView (www.brightviewhealth.com). Patients performed self-tracking of their recovery behavior (e.g., counseling attendance, abstinence from drugs and alcohol) addiction recovery behavior using the DynamiCare app, which follows Contingency Management (CM) model of incentivizing positive behavior.
CM is shown as a highly effective, evidence-based methodology for improving substance use disorder (SUD) outcomes. It does so by activating the brain's reward and inhibitory systems through both positive and negative reinforcement using immediate, concrete incentives in a progressive reinforcement schedule. CM involves setting frequent (>1/week), objective goals (usually abstinence or participation in treatment), which patients can achieve to earn tangible rewards (such as cash or vouchers). The DynamiCare smart phone app (iOS/Android) uses CM to incentivize patients to attend scheduled appointments and to submit negative alcohol and drug tests as they are rewarded for these behaviors. The intentions of this project were to assess whether use of the smartphone app as an add-on to treatment as usual could increase treatment retention, increase the percentage of appointments that were kept, and if substance use could be reduced for patients using the app.
Patients were enrolled in the study on a rolling basis from Jan 25, 2019 to March 29, 2019 until the desired cohort group # was reached (n=108). The intervention period (period of time when patients actually used the DynamiCare app) lasted four months from the date of their enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DynamiCare group | – | Device: Smartphone appPatients at Morgan Street location of BrightView who were given the DynamiCare smartphone app. |
| Non-DynamiCare group | – | –Patients at Colerain location of BrightView who were not given the DynamiCare smartphone app. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study focused on a population of 108 adult patients with a primary diagnosis of substance use disorder who were enrolled at a BrightView outpatient treatment center.
Key inclusion criteria (6 listed)
- >18 years old
- Substance use disorder (SUD) as a primary diagnosis
- Have and use an Android or iOS smartphone with acceptable capability
- Are willing to participate in home testing and use of the smartphone
- Speak and read the English language adequately to understand smartphone commands and responses
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Smartphone appStudy procedures related to the DynamiCare Rewards intervention were conducted via smartphone. Research visits included collection of urine samples and medical exams. Participants assigned to the DynamiCare Rewards group received: 1) the app on their smartphone, 2) drug testing devices when indicated (pocket-sized breathalyzer), and a reloadable debit card for receiving the financial incentives (the PEX debit card). Global Positioning System (GPS) tracking was used to track whether patients had attended their scheduled appointments but was not used at any other times. All information was uploaded from the app onto the DynamiCare Analytics website, which treatment providers could view. The information reported was: attendance status of appointments, the status of all alcohol and drug testing, and incentives earned. Each patient's intervention period (period of time when they used the app) lasted four months from the date of their enrollment. | Device | DynamiCare group |
Primary outcome
Attendance
Time frame: 4 months
The DynamiCare smart phone app was used to see whether the percentage of scheduled appointments could be increased by using the app. As measured by % of attendance of medical and clinical appointments compared to controls.
Substance Use
Time frame: 4 months
The DynamiCare smart phone app was used to see if use of the app could reduce substance use as measured by urine toxicology results. Measured percentage of patients using the app testing consistent only for prescribed substances in random clinical urine tests compared to controls.
Retention
Time frame: 4 months
The DynamiCare smart phone app was used to see if treatment retention could be increased when the app was added to treatment as usual. Measured as the percent of patients who are still active in the DynamiCare app and attending treatment sessions after 1, 2, 3, and 4 months compared to controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- BrightView -- Outpatient addiction treatment center conducting the studyLink provided by the sponsor.
- DynamiCare Health -- Maker of the smartphone app used in the studyLink provided by the sponsor.
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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.
Shawn Ryan, MD, MBA principal investigator
President & CMO
Samin Rezania, PhD study director
Director of Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by BrightView LLC at 1 site 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 6 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Attendance (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2019.