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

28 oktober 2026 bijgewerkt door: Michael Incze

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Gedragsmatig: 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
Actieve vergelijker: 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
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in metabolic equivalents (METs)
Tijdsspanne: Baseline, 1, 3, and 6 months

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
Tijdsspanne: Baseline, 1, 3, and 6 months

Change in self-reported substance use amount and frequency via Timeline Follow Back (TLFB)
Baseline, 1, 3, and 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of Life - Short Form 20
Tijdsspanne: Baseline, 1, 3, and 6 months

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
Tijdsspanne: Baseline, 1, 3, and 6 months

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.
Tijdsspanne: Baseline, 1, 3, and 6 months

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
Tijdsspanne: Baseline, 1, 3, and 6 months

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
Tijdsspanne: 3 months and 6 months

Number of weekly App Log-Ins, Contingency Management Draws and Earnings
3 months and 6 months
Hospital Readmissions in the Past 30 Days
Tijdsspanne: Baseline, 1, 3, and 6 months

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
Tijdsspanne: Baseline, 1, 3, and 6 months

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
Tijdsspanne: Baseline, 1, 3, and 6 months

Self-Reported number of urgent care visits in the past 30 days using Timeline Follow Back
Baseline, 1, 3, and 6 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
Tijdsspanne: immediately after the intervention (12 weeks from randomization)

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)
Tijdsspanne: immediately after the intervention (12 weeks from randomization)

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
Tijdsspanne: Measured starting from the first randomization and ending after the final participant is randomized (up to 100 weeks after first randomization)

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
Tijdsspanne: Measured between 12 weeks (end of intervention) and 24 weeks after randomization

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
Tijdsspanne: 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)

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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Michael Incze

Medewerkers

National Institute on Drug Abuse (NIDA)
University of Utah

Onderzoekers

  • Hoofdonderzoeker: Michael A Incze, MD, University of Utah

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 oktober 2026

Primaire voltooiing (Geschat)

31 oktober 2028

Studie voltooiing (Geschat)

31 oktober 2028

Studieregistratiedata

Eerst ingediend

12 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB_00204022
  • 1R21DA066520-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Data will be available within 12 months of study conclusion

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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