Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions (INSPIRE)

Feasibility of a Remote Collaborative Care-Facilitated Contingency Management-Exercise Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of increasing control over stimulant use and physical health through incentivized rehabilitation (INSPIRE). INSPIRE is a 12-week remotely-delivered collaborative care intervention for rural patients with Methamphetamine-Associated Heart Failure (Me-HF) or Methamphetamine-Associated Pulmonary Arterial Hypertension (Me-PAH) featuring smartphone-based contingency management incentivizing participation in remote synchronous rehabilitation.

Study Overview

• Status: Recruiting
• Conditions: Methamphetamine-Associated Heart Failure; Methamphetamine-Associated Pulmonary Arterial Hypertension
• Intervention / Treatment: Behavioral: Increasing control over stimulant use and physical health through incentivized rehabilitation; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael A Incze, MD; Phone Number: 801-581-2000; Email: Michael.Incze@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah Health
      • Contact: Michael A Incze, MD; Phone Number: 801-581-2000; Email: Michael.Incze@hsc.utah.edu
      • Contact: Dominique Ingram; Phone Number: 801-581-2000; Email: dominique.ingram@utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Active methamphetamine use determined by positive urine drug testing within the past 3 months and/or self-reported current use
• Current diagnosis of chronic heart failure or pulmonary hypertension documented in the electronic health record
• Possession of a smartphone
• Able to participate in virtual exercise rehabilitation

Exclusion Criteria:

• Currently incarcerated
• Unable to interact with smartphone app and/or virtual health coaching sessions in English
• Unstable arrhythmia, defined as any known arrhythmia that is associated with hemodynamic effects like syncope, hypotension, or decompensated heart failure
• Decompensated chronic heart failure or pulmonary hypertension
• NYHA class IV symptoms
• Myocardial infarction within the past 3 months, percutaneous coronary intervention within the past 2 weeks, coronary artery bypass graft within the past 3 months, or implantable cardiac defibrillator/cardiac resynchronization therapy/pacemaker implantation within the last 6 weeks
• Unstable angina, uncontrolled hypertension, acute myocarditis/pericarditis, intracardiac thrombus
• Severe symptomatic aortic stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INSPIRE; Participants randomized to INSPIRE will receive usual medical care plus a 12-week program featuring collaborative care and app-based contingency management incentivizing participation in remotely-delivered synchronous exercise rehabilitation sessions	Behavioral: Increasing control over stimulant use and physical health through incentivized rehabilitation; Standard medical care plus a 12-week program featuring collaborative care and app-based contingency management incentivizing participation in remotely-delivered synchronous exercise rehabilitation sessions
Active Comparator: Usual Care; Participants randomized to Usual Care will receive standard of care services routinely available at the University of Utah, including specialty cardiology, pulmonology and addiction care and in-person cardiac and pulmonary rehabilitation services	Other: Usual Care; Standard care services routinely available at the University of Utah Health, including specialty cardiology, pulmonology and addiction care and in-person cardiac and pulmonary rehabilitation services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in metabolic equivalents (METs)	Change in METs before and after the intervention measured via Duke Activity Status Indicator (DASI)	Baseline, 1, 3, and 6 months
Change in self-reported substance use	Change in self-reported substance use amount and frequency via Timeline Follow Back (TLFB)	Baseline, 1, 3, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life - Short Form 20	Measure of participants' quality of life using the Short Form 20 (SF-20) questionnaire. The score range of this survey is 0-100, with higher scores indicating better overall quality of life.	Baseline, 1, 3, and 6 months
Quality of Life - Kansas City Cardiomyopathy Questionnaire-12	Measure of participant's quality of life using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The score range of this survey is 0-100, with higher scores indicating better functioning and less limitation from heart failure symptoms.	Baseline, 1, 3, and 6 months
Self-Efficacy Related to Avoiding Substance Use with the Drug Avoidance Self-Efficacy Scale (DASES). The score range of this survey is 0-96, with higher scores indicating better self-efficacy to avoid substance use.	Measure of self-efficacy to avoid substance use with the Drug Avoidance Self-Efficacy Scale (DASES).	Baseline, 1, 3, and 6 months
Recovery Capital using the Brief Assessment of Recovery Capital (BARC-10) questionnaire	Measure of the internal and external resources (recovery capital) that help initiate and sustain recovery from substance use disorder, using the Brief Assessment of Recovery Capital (BARC-10) questionnaire. The score range of this survey is 10-60, with higher scores indicating a greater amount of recovery capital.	Baseline, 1, 3, and 6 months
Contingency Management App Engagement	Number of weekly App Log-Ins, Contingency Management Draws and Earnings	3 months and 6 months
Hospital Readmissions in the Past 30 Days	Self-Reported Hospital admissions in the past 30 days using Timeline Follow Back	Baseline, 1, 3, and 6 months
Emergency Department Visits in the Past 30 days	Self-Reported number of ED visits in the past 30 days using Timeline Follow Back	Baseline, 1, 3, and 6 months
Urgent Care Visits in the Past 30 Days	Self-Reported number of urgent care visits in the past 30 days using Timeline Follow Back	Baseline, 1, 3, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)	Measure of INSPIRE acceptability through the IAM survey collected one time from all patient participants one time at the end of the intervention	immediately after the intervention (12 weeks from randomization)
INSPIRE Appropriateness assessed via 4-item Appropriateness of Intervention Measure (AIM)	Measure of INSPIRE appropriateness through Appropriateness of Intervention Measure (AIM) collected one time from all patient participants one time at the end of the intervention	immediately after the intervention (12 weeks from randomization)
Reach of the Intervention Over the Entire Study Period	Number of different counties and states represented by enrolled participants measured from the first randomization to the final randomization.	Measured starting from the first randomization and ending after the final participant is randomized (up to 100 weeks after first randomization)
Sustainment of intervention	Number of intervention participants who continue to log into the contingency management/peer support app in the three months after the intervention ends as assessed through app utilization data	Measured between 12 weeks (end of intervention) and 24 weeks after randomization
Feasibility	Average number of enrollments per month and percentage of enrolled participants who complete the intervention	Measured starting from the first randomization and ending after the final participant has completed the intervention, discontinued the study, or was lost to follow-up (up to 112 weeks after first randomization)

Collaborators and Investigators

• Sponsor: Michael Incze
• Collaborators: National Institute on Drug Abuse (NIDA); University of Utah
• Investigators: Principal Investigator: Michael A Incze, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: October 12, 2026
• First Submitted That Met QC Criteria: October 28, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 28, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Telehealth; Mobile App; Cardiac Rehabilitation; Contingency Management; Methamphetamine; Substance Use Disorders; Collaborative Care; Stimulant Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB_00204022; 1R21DA066520-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Individual de-identified responses to the following surveys will be preserved and shared: 1) SF-20, 2) Kansas City Cardiomyopathy Questionnaire-12, 3) DASI, 4) TLFB data, 5) Drug Avoidance Self-Efficacy Scale, 6) BARC-10, 7) Appropriateness of Intervention Measure, 8) Intervention Acceptability Measure, and 9) App engagement and CM earnings data, 10) Self-reported data on substance use and acute care utilization, 11) demographic and substance use history enrollment surveys. De-identified biometric data and qualitative interview transcripts will also be preserved and shared.

All data will be stored within a secure computing environment. All participant identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Participant identifiers will not be shared.

IPD Sharing Time Frame

Data will be available within 12 months of study conclusion

IPD Sharing Access Criteria

Data will be archived in The Hive. The Hive is a publicly-accessible repository for research data generated by UHealth researchers, students, and staff. It is maintained by the Marriott Library IT and Digital Collections. The Hive has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data-sharing policies and applicable laws and regulations. Deidentified data within The Hive will be shared with other investigators who propose specific aims/hypotheses in order to identify the data elements required and who receive agreement from the appropriate project leaders.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No