Smartphone App for Veteran Opioid Use Disorder Treatment
This study is developing and testing a smartphone app called ACT to RECOVER to help Veterans with Opioid Use Disorder (OUD) who are receiving medication treatment (like buprenorphine or methadone). OUD is a long-term condition that can affect a person's social life, work, and overall health. The app is based on Acceptance and Commitment Therapy (ACT), which helps people manage their thoughts and feelings to live a more fulfilling life. Researchers want to see if ACT to RECOVER is acceptable to users and how much they use it. The study aims to enroll 75 Veterans who have OUD, are currently on medication treatment, and have a working smartphone.
- Study design
- This is an interventional study with a planned enrollment of 75 participants. It involves comparing the ACT to RECOVER app to a smartphone-based symptom monitoring program.
- What's involved
- Participants will use a smartphone app and their app usage will be continuously tracked from baseline (week 0) through follow-up (week 5). They will also complete a survey at baseline and at week 4.
- Compensation
- Not stated in the trial record.
- Follow-up
- App usage will be tracked continuously through follow-up at week 5.
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Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Noah R Wolkowicz, PhD · PRINCIPAL_INVESTIGATOR · VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Who to contact
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Inclusion
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What this trial measures
- Theoretical Framework of Acceptability (TFA) scalePhase 3 (Stage 1b RCT): Baseline (week 0); Endpoint (Week 4)
The Theoretical Framework of Acceptability provides a rigorous framework for assessing the acceptability of health information technology, offering both prospective and retrospective acceptability scales, which respectively assess how acceptable one believes they will find a health intervention and how acceptable they found the intervention after use. The investigators will use the prospective scale (i.e., assessing how acceptable participants think the ACT to RECOVER app would be if they were to use as part of their treatment). The TFA's scale asks participants to rate 7 dimensions of acceptability (affective attitude towards a health intervention, burden, value alignment, understanding of intervention functioning, perceived benefit, perceived effectiveness, and self-efficacy) on a 5-point scale, with avg.'s \>3 indicating minimum degrees of acceptability.
- App usage: OpeningsPhase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)
Continuously-recorded via smartphone apps in respective conditions as a frequency count of the number of times a respective app is opened.
- App usage: DurationPhase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)
Continuously-recorded via smartphone apps in respective conditions as the total duration of time (as number of minutes) spent using the respective app.
- Enrollment: Enrollment RateEnd of Month 60 (Final month of project, upon which completion of Phase 3 (Stage 1b RCT) recruitment and follow-up is anticipated to complete)
Participant enrollment rate. Study target is \>2 participants/month on avg., assessed upon completion of Stage 3 study procedures.
- App usage: CompletionPhase 3 (Stage 1b RCT): Tracked continuously from Baseline (week 0) through Follow-up (week 5)
Continuously-recorded via smartphone apps in respective conditions as the number of module/symptom reports completed. Targets are for an avg. of \>3/6 ACT to RECOVER modules + 1 General module completed (ACT to RECOVER condition) or an avg. of \>15/30 days of symptom monitoring reports (symptom monitoring control condition).
- Enrollment: AttritionEnd of Month 60 (Final month of project, upon which completion of Phase 3 (Stage 1b RCT) recruitment and follow-up is anticipated to complete)
Percentage of participant attrition. Study target is \<35.5% per study arm, assessed upon completion of Stage 3 study procedures.
- Systems Usability Scale (SUS)Phase 3 (Stage 1b RCT): Endpoint (Week 4)
The SUS is a 10-item measure, scored on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5), that assesses human-computer interaction. The SUS generates a subjective evaluation score using a globally accepted scale and to understand if the system in its current form is sufficiently usable. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of system usability. SUS scores have a range of 0 to 100, with higher scores suggesting greater system usability. A SUS score above 68 (study target) is regarded as above average, and a SUS score above 80 is regarded as high and a score above which participants are likely to recommend the product to friends.