Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-29
Brief Title:
Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Developing a Smartphone Application to Support the Functional Needs of Veterans in Medication Treatment for Opioid Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Opioid Use Disorder OUD is a complex chronic condition affecting nearly 70000 Veterans who can experience significantly reduced quality of life eg poorer social occupational and health-related functioning VA clinics providing Medication treatment for OUD MOUD eg buprenorphine methadone the 1st-line treatment for OUD often face challenges in also attempting to treat Veteran functional needs which may require them to extend beyond their available resources to provide support There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD
Acceptance and Commitment Therapy ACT is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support However the traditional practice ACT requires a trained clinician to provide weekly hour-long therapy sessions typically for 12-16 weeks and may be too burdensome for MOUD clinics to use alongside standard care
Fortunately emerging research suggests that mobile health interventions MHIs eg smartphone apps can overcome many of these pragmatic barriers MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in real-world settings through minimally burdensome and accessible formats Currently however no MHIs targeting functioning exist for Veterans in MOUD
The proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called ACT to RECOVER Acceptance and Commitment Therapy to Reach Empowerment through Commitment Openness and Valuing Experiences in Recovery
The study will occur in 3 phases
Phase 1 Development Develop content for ACT to RECOVER using Veteran n10 and provider feedback n10
Phase 2 Iterative Usability Assessment Conduct field testing 3 rounds n4-5 per round to refine ACT to RECOVER format acceptability and usability
Phase 3 Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial RCT Conduct a pilot trial to compare ACT to RECOVER n20 to a smartphone-based symptom monitoring control group n20
3a Evaluate the acceptability and feasibility of each conditions app and study procedures
3b Explore changes in functional eg values-based living quality of life and clinical outcomes eg illicit opioid use which will be key outcomes in future efficacy testing
Acceptance and Commitment Therapy ACT is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support However the traditional practice ACT requires a trained clinician to provide weekly hour-long therapy sessions typically for 12-16 weeks and may be too burdensome for MOUD clinics to use alongside standard care
Fortunately emerging research suggests that mobile health interventions MHIs eg smartphone apps can overcome many of these pragmatic barriers MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in real-world settings through minimally burdensome and accessible formats Currently however no MHIs targeting functioning exist for Veterans in MOUD
The proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called ACT to RECOVER Acceptance and Commitment Therapy to Reach Empowerment through Commitment Openness and Valuing Experiences in Recovery
The study will occur in 3 phases
Phase 1 Development Develop content for ACT to RECOVER using Veteran n10 and provider feedback n10
Phase 2 Iterative Usability Assessment Conduct field testing 3 rounds n4-5 per round to refine ACT to RECOVER format acceptability and usability
Phase 3 Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial RCT Conduct a pilot trial to compare ACT to RECOVER n20 to a smartphone-based symptom monitoring control group n20
3a Evaluate the acceptability and feasibility of each conditions app and study procedures
3b Explore changes in functional eg values-based living quality of life and clinical outcomes eg illicit opioid use which will be key outcomes in future efficacy testing
Detailed Description:
PHASE 1 Initial Development of the ACT to RECOVER System Phase 1 Development Phase Months 0-15 15 months Veterans in MOUD n10 and VA MOUD clinical staff n10 will provide feedback and input on the intervention content drafts developed by the study team
ACT to RECOVER Content ACT to RECOVER will be designed to act as a flexible semi- structured user-friendly mobile application adjunct to MOUD Content will include components appropriate for either self-management andor use with providers ACT to RECOVER will be designed to have major ACT-focused modules completable within 1 month though Veterans will be able to continue using the app and its features after study completion upon request Core content for ACT to RECOVERs modules will be adapted from major ACT texts eg Hayes and colleagues Acceptance and Commitment Therapy The Process and Practice of Mindful Change and technology eg VA ACT Coach Core Content modules will cover 1 Behavior change and addiction triggers 2 values clarification 3 acceptance 4 cognitive defusing 5 committed action and 6 willingness Additional general content modules will also be included eg providing support for medication and appointment tracking to support treatment engagement
Phase 1 Qualitative Interviews Interview Guide Interviews will include open-ended questions on ACT to RECOVERs acceptability feasibility of engagement potential concerns and initial reactions Interview questions are based on the Practical Robust Implementation and Sustainability Model PRISM
Interview Analysis Qualitative data analysis will use a thematic approach with the goal of ascertaining intervention acceptability feasibility of engagement and referral issues Two independent reviewers will code each interview transcription using open-ended coding Each element will be summarized separately and themes and key points will be generated to assess data saturation Two reviewers will analyze the qualitative data using modified grounded coding to identify themes from audio recordings after each interview Intervention areas will be modified as feedback is given Each set of interviews will take place with 3-4 participants per group The number of changes needed for each intervention area will be tracked it is anticipated that less intervention refinement will be needed by the end of the interview cycle If later interviews still suggest a need for significant refinement eg increasing number of changes needed further testing will be done
PHASE 2 Iterative Usability Testing Phase 2 Pilot Evaluation of Intervention Components in Field-Based Iterative Usability Testing Months 15-33 18 months Veterans will be recruited in MOUD N12-15 to conduct usability and content acceptability testing of ACT to RECOVER across 3 iterative waves n4-5 per wave
Iterative Usability Assessment Procedures Eligible Veterans will come to the VACHS West Haven campus to complete baseline measures Following Veterans will be provided with a smartphone containing a beta-version of ACT to RECOVER First Veterans will be walked through portions of the mobile application and its user interface Different images for options of the ACT to RECOVER app as well as a PowerPoint with information about the user interface will be shown to simulate the intervention and its user interface Second Veterans will be provided with written instructions and asked to do a behavioral walk-through of a portion of the ACT to RECOVER system using the beta app version and provided PowerPoint slides Third Veterans will be asked to move through the ACT to RECOVER system unguided Throughout a combined usability and contextual interview approach will be used in which participant system use is recorded while they are asked questions about their engagement and preferences Finally participants will complete acceptability and usability measures as well as a semi-structured qualitative exit interview An average of 2 weeks between waves to allow time for Geisel Software Inc to address identified functionality and interface concerns Gono-go limits to determine whether Phase 3 should commence are set a priori see section 6b Outcome Measures
Data Collection and Analysis Quantitative statistics will be computed and reported to describe the sample and assess for pre-defined gono-go limits for the next Phase In accordance with an adapted Integrated Technology Acceptance Model ITAM framework correlations will also be assessed between health factors and demographic information with intrinsic motivation perceived ease of useusefulness and behavioral intent to use ACT to RECOVER It is expected that positive correlations between all ITAM constructs will be present
Qualitative Combined Usability and Contextual Interview Analysis During usability sessions participants will assess ACT to RECOVER using a think-aloud protocol verbalizing their thoughts as they navigate the app After a period of exploration with the app the research staff will use a pre-created protocol to ask Veterans to perform a series of tasks eg accessing different modules Session and on-screen recording will occur alongside real-time observation Additionally Veterans will complete a series of brief usability questionnaires following user testing and the qualitative interview
A modified consensual qualitative research CQR approach will be used to code the session transcriptions Research team investigators initial codebook based on key activities and questions in the user-testing protocol will be developed and employed for identifying usability themes within screen-recorded videos with additional research staff identified to act as a code auditor a Two coders utilize the initial codebook throughout data analysis to foster multiple perspectives b consensus is reached between coders about the meaning of the data c at least one auditor must check the work of the primary team of judges to minimize potential bias and d domain and theme frequency are reported
Themes will then be categorized according to the following CQR groupings general include all or all but one of the cases typical include more than half of the cases up to the cut off for general and variant at least two cases up to the cutoff for typical General comments will be classified regarding usability as necessary to include in iterative development typical and variant will be discussed within the research group to decide upon potential ways to incorporate this feedback into intervention refinement Feedback will then be triangulated per testing wave by 1 summarizing suggested changes 2 obtaining study team input and 3 meeting with the software development team to implement changes
PHASE 3 Stage 1b Pilot RCT Phase 3 Stage 1b Pilot RCT Months 33-60 27 months A Stage 1b RCT pilot will be conducted to assess the acceptability treatment satisfaction perceived ease of use and usefulness behavioral intent to use actual use and feasibility recruitment treatment receptivity sustained participation and attrition in each condition of comparing ACT to RECOVER n20 to a smartphone-based symptom monitoring control condition n20 Phase 3 will focus on 3a assessing the acceptability and feasibility of the intervention and research procedures and 3b exploring the data characteristics of and describing changes in functional eg values-consistent living and clinical outcomes eg illicit opioid use
Stage 1b Pilot RCT Procedures At the start of this visit research staff will confirm participant eligibility and verify informed consent Following Veterans will complete baseline demographic and health measures as well as relevant outcome measures Veterans will have been randomized to receive either ACT to RECOVER treatment arm or smartphone-based symptom monitoring control condition prior to their baseline study visit with instructions for the appropriate app download and use provided during the baseline session please refer to section 7 Arms Interventions for details Veterans will be asked to use the respective conditions app over the next 5 weeks and to attend midpoint week 2 endpoint week 4 and follow-up week 5 study visits during which indicated measures will be collected see section 6b Outcome Measures
Semi-structured qualitative exit interview A 30-minute semi-structured qualitative interview will be conducted with Veterans in both arms during the endpoint assessment to further assess acceptability feasibility usability and dissemination issues Questions will inquire about any problems with app access and use perceived effects if Veterans would recommend the app to a friend and recommended changes
Data Management and Statistical Analysis Power analysis Consistent with the NIH Stage model for intervention development this Stage 1b RCT will focus on determining the acceptability and feasibility of a given intervention and study procedures vs efficacy testing and accordingly proposes a sample of N40 n20 eligible participants per group
Primary Analyses and Hypotheses Stage 1b RCT - Aim 3a Acceptability and feasibility of study intervention and procedures Targets for aim 3a include descriptively assessing if the ACT to RECOVER and smartphone-based symptom monitoring control apps reach thresholds for intervention acceptability feasibility and maintenance of usability thresholds see section 6b Study Outcomes for details on these measures and thresholds If study thresholds are not met the study team and Geisel Softwares development team will convene to discuss further intervention andor study procedure refinement which may include additional data collection until thresholds are met Threshold achievement would indicate the ACT to RECOVER system and trial procedures are suitable for a subsequent efficacy trial
Aim 3a Hypotheses
It is hypothesized that all constructs will positively correlate with each other eg greater medical care satisfaction info seeking and health care need will positively correlate with intrinsic motivation for app use which will positively correlate with perceived ease of use and usefulness behavioral intention to use the app and ultimately with actual app use Analysis of post-intervention interviews will also be done using notes taken by study staff during the exit interview interviews will also be audiotaped and transcribed for later analysis Research staff will apply CRQ qualitative analytic techniques to these data eg coding and extracting major themes to assess barriers and facilitators to app use per condition
Secondary Analyses Stage 1b RCT - Aim 3b Descriptive analyses to provide preliminary empirical evidence for a subsequent efficacy trial and inform its design
Consistent with the Stage of Phase 3s proposed trial Aim 3b will also assess if the proposed study procedures are suitable to collect the requisite data for future efficacy testing For each condition the study team will calculate descriptive statistics assess univariate distributions explore bivariate relationships and conduct paired-samples t-tests to evaluate the potential changes in functional and clinical outcomes within-subjects These analyses will examine baseline in comparison to each subsequent study interval ie baseline vs midpoint baseline vs endpoint baseline vs 5-week follow-up and will be conducted on the whole sample as well as stratified by group
Aim 3b Hypotheses
It is hypothesized that those in the ACT to RECOVER condition will demonstrate an increase in values-based living quality of life and MOUD compliance for Veterans in the ACT to RECOVER condition as well as a decrease in behavioral avoidance illicit opioid use and substance-related problems
ACT to RECOVER Content ACT to RECOVER will be designed to act as a flexible semi- structured user-friendly mobile application adjunct to MOUD Content will include components appropriate for either self-management andor use with providers ACT to RECOVER will be designed to have major ACT-focused modules completable within 1 month though Veterans will be able to continue using the app and its features after study completion upon request Core content for ACT to RECOVERs modules will be adapted from major ACT texts eg Hayes and colleagues Acceptance and Commitment Therapy The Process and Practice of Mindful Change and technology eg VA ACT Coach Core Content modules will cover 1 Behavior change and addiction triggers 2 values clarification 3 acceptance 4 cognitive defusing 5 committed action and 6 willingness Additional general content modules will also be included eg providing support for medication and appointment tracking to support treatment engagement
Phase 1 Qualitative Interviews Interview Guide Interviews will include open-ended questions on ACT to RECOVERs acceptability feasibility of engagement potential concerns and initial reactions Interview questions are based on the Practical Robust Implementation and Sustainability Model PRISM
Interview Analysis Qualitative data analysis will use a thematic approach with the goal of ascertaining intervention acceptability feasibility of engagement and referral issues Two independent reviewers will code each interview transcription using open-ended coding Each element will be summarized separately and themes and key points will be generated to assess data saturation Two reviewers will analyze the qualitative data using modified grounded coding to identify themes from audio recordings after each interview Intervention areas will be modified as feedback is given Each set of interviews will take place with 3-4 participants per group The number of changes needed for each intervention area will be tracked it is anticipated that less intervention refinement will be needed by the end of the interview cycle If later interviews still suggest a need for significant refinement eg increasing number of changes needed further testing will be done
PHASE 2 Iterative Usability Testing Phase 2 Pilot Evaluation of Intervention Components in Field-Based Iterative Usability Testing Months 15-33 18 months Veterans will be recruited in MOUD N12-15 to conduct usability and content acceptability testing of ACT to RECOVER across 3 iterative waves n4-5 per wave
Iterative Usability Assessment Procedures Eligible Veterans will come to the VACHS West Haven campus to complete baseline measures Following Veterans will be provided with a smartphone containing a beta-version of ACT to RECOVER First Veterans will be walked through portions of the mobile application and its user interface Different images for options of the ACT to RECOVER app as well as a PowerPoint with information about the user interface will be shown to simulate the intervention and its user interface Second Veterans will be provided with written instructions and asked to do a behavioral walk-through of a portion of the ACT to RECOVER system using the beta app version and provided PowerPoint slides Third Veterans will be asked to move through the ACT to RECOVER system unguided Throughout a combined usability and contextual interview approach will be used in which participant system use is recorded while they are asked questions about their engagement and preferences Finally participants will complete acceptability and usability measures as well as a semi-structured qualitative exit interview An average of 2 weeks between waves to allow time for Geisel Software Inc to address identified functionality and interface concerns Gono-go limits to determine whether Phase 3 should commence are set a priori see section 6b Outcome Measures
Data Collection and Analysis Quantitative statistics will be computed and reported to describe the sample and assess for pre-defined gono-go limits for the next Phase In accordance with an adapted Integrated Technology Acceptance Model ITAM framework correlations will also be assessed between health factors and demographic information with intrinsic motivation perceived ease of useusefulness and behavioral intent to use ACT to RECOVER It is expected that positive correlations between all ITAM constructs will be present
Qualitative Combined Usability and Contextual Interview Analysis During usability sessions participants will assess ACT to RECOVER using a think-aloud protocol verbalizing their thoughts as they navigate the app After a period of exploration with the app the research staff will use a pre-created protocol to ask Veterans to perform a series of tasks eg accessing different modules Session and on-screen recording will occur alongside real-time observation Additionally Veterans will complete a series of brief usability questionnaires following user testing and the qualitative interview
A modified consensual qualitative research CQR approach will be used to code the session transcriptions Research team investigators initial codebook based on key activities and questions in the user-testing protocol will be developed and employed for identifying usability themes within screen-recorded videos with additional research staff identified to act as a code auditor a Two coders utilize the initial codebook throughout data analysis to foster multiple perspectives b consensus is reached between coders about the meaning of the data c at least one auditor must check the work of the primary team of judges to minimize potential bias and d domain and theme frequency are reported
Themes will then be categorized according to the following CQR groupings general include all or all but one of the cases typical include more than half of the cases up to the cut off for general and variant at least two cases up to the cutoff for typical General comments will be classified regarding usability as necessary to include in iterative development typical and variant will be discussed within the research group to decide upon potential ways to incorporate this feedback into intervention refinement Feedback will then be triangulated per testing wave by 1 summarizing suggested changes 2 obtaining study team input and 3 meeting with the software development team to implement changes
PHASE 3 Stage 1b Pilot RCT Phase 3 Stage 1b Pilot RCT Months 33-60 27 months A Stage 1b RCT pilot will be conducted to assess the acceptability treatment satisfaction perceived ease of use and usefulness behavioral intent to use actual use and feasibility recruitment treatment receptivity sustained participation and attrition in each condition of comparing ACT to RECOVER n20 to a smartphone-based symptom monitoring control condition n20 Phase 3 will focus on 3a assessing the acceptability and feasibility of the intervention and research procedures and 3b exploring the data characteristics of and describing changes in functional eg values-consistent living and clinical outcomes eg illicit opioid use
Stage 1b Pilot RCT Procedures At the start of this visit research staff will confirm participant eligibility and verify informed consent Following Veterans will complete baseline demographic and health measures as well as relevant outcome measures Veterans will have been randomized to receive either ACT to RECOVER treatment arm or smartphone-based symptom monitoring control condition prior to their baseline study visit with instructions for the appropriate app download and use provided during the baseline session please refer to section 7 Arms Interventions for details Veterans will be asked to use the respective conditions app over the next 5 weeks and to attend midpoint week 2 endpoint week 4 and follow-up week 5 study visits during which indicated measures will be collected see section 6b Outcome Measures
Semi-structured qualitative exit interview A 30-minute semi-structured qualitative interview will be conducted with Veterans in both arms during the endpoint assessment to further assess acceptability feasibility usability and dissemination issues Questions will inquire about any problems with app access and use perceived effects if Veterans would recommend the app to a friend and recommended changes
Data Management and Statistical Analysis Power analysis Consistent with the NIH Stage model for intervention development this Stage 1b RCT will focus on determining the acceptability and feasibility of a given intervention and study procedures vs efficacy testing and accordingly proposes a sample of N40 n20 eligible participants per group
Primary Analyses and Hypotheses Stage 1b RCT - Aim 3a Acceptability and feasibility of study intervention and procedures Targets for aim 3a include descriptively assessing if the ACT to RECOVER and smartphone-based symptom monitoring control apps reach thresholds for intervention acceptability feasibility and maintenance of usability thresholds see section 6b Study Outcomes for details on these measures and thresholds If study thresholds are not met the study team and Geisel Softwares development team will convene to discuss further intervention andor study procedure refinement which may include additional data collection until thresholds are met Threshold achievement would indicate the ACT to RECOVER system and trial procedures are suitable for a subsequent efficacy trial
Aim 3a Hypotheses
It is hypothesized that all constructs will positively correlate with each other eg greater medical care satisfaction info seeking and health care need will positively correlate with intrinsic motivation for app use which will positively correlate with perceived ease of use and usefulness behavioral intention to use the app and ultimately with actual app use Analysis of post-intervention interviews will also be done using notes taken by study staff during the exit interview interviews will also be audiotaped and transcribed for later analysis Research staff will apply CRQ qualitative analytic techniques to these data eg coding and extracting major themes to assess barriers and facilitators to app use per condition
Secondary Analyses Stage 1b RCT - Aim 3b Descriptive analyses to provide preliminary empirical evidence for a subsequent efficacy trial and inform its design
Consistent with the Stage of Phase 3s proposed trial Aim 3b will also assess if the proposed study procedures are suitable to collect the requisite data for future efficacy testing For each condition the study team will calculate descriptive statistics assess univariate distributions explore bivariate relationships and conduct paired-samples t-tests to evaluate the potential changes in functional and clinical outcomes within-subjects These analyses will examine baseline in comparison to each subsequent study interval ie baseline vs midpoint baseline vs endpoint baseline vs 5-week follow-up and will be conducted on the whole sample as well as stratified by group
Aim 3b Hypotheses
It is hypothesized that those in the ACT to RECOVER condition will demonstrate an increase in values-based living quality of life and MOUD compliance for Veterans in the ACT to RECOVER condition as well as a decrease in behavioral avoidance illicit opioid use and substance-related problems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IK2 RX005015-01A1 | OTHER_GRANT | Rehabilitation Research Development | None |