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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Michael A Incze, MD
- Telefonnummer: 801-581-2000
- E-Mail: Michael.Incze@hsc.utah.edu
Studienorte
-
-
Utah
-
Salt Lake City, Utah, Vereinigte Staaten, 84108
- Rekrutierung
- University of Utah Health
-
Kontakt:
- Michael A Incze, MD
- Telefonnummer: 801-581-2000
- E-Mail: Michael.Incze@hsc.utah.edu
-
Kontakt:
- Dominique Ingram
- Telefonnummer: 801-581-2000
- E-Mail: dominique.ingram@utah.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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 |
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 |
|
Aktiver Komparator: 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 |
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in metabolic equivalents (METs)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quality of Life - Short Form 20
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Michael A Incze, MD, University of Utah
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB_00204022
- 1R21DA066520-01 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Zeitrahmen
Data will be available within 12 months of study conclusion
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .