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

28 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

45

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comportamentale: 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
Comparatore attivo: 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
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in metabolic equivalents (METs)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life - Short Form 20
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Michael Incze

Collaboratori

National Institute on Drug Abuse (NIDA)
University of Utah

Investigatori

  • Investigatore principale: Michael A Incze, MD, University of Utah

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 ottobre 2026

Completamento primario (Stimato)

31 ottobre 2028

Completamento dello studio (Stimato)

31 ottobre 2028

Date di iscrizione allo studio

Primo inviato

12 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB_00204022
  • 1R21DA066520-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Data will be available within 12 months of study conclusion

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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