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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Michael A Incze, MD
- Номер телефона: 801-581-2000
- Электронная почта: Michael.Incze@hsc.utah.edu
Места учебы
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84108
- Рекрутинг
- University of Utah Health
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Контакт:
- Michael A Incze, MD
- Номер телефона: 801-581-2000
- Электронная почта: Michael.Incze@hsc.utah.edu
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Контакт:
- Dominique Ingram
- Номер телефона: 801-581-2000
- Электронная почта: dominique.ingram@utah.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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 |
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Активный компаратор: 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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in metabolic equivalents (METs)
Временное ограничение: 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
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Change in self-reported substance use
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quality of Life - Short Form 20
Временное ограничение: 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
Временное ограничение: 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
|
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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.
Временное ограничение: 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
|
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Recovery Capital using the Brief Assessment of Recovery Capital (BARC-10) questionnaire
Временное ограничение: 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
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Contingency Management App Engagement
Временное ограничение: 3 months and 6 months
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Number of weekly App Log-Ins, Contingency Management Draws and Earnings |
3 months and 6 months
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Hospital Readmissions in the Past 30 Days
Временное ограничение: Baseline, 1, 3, and 6 months
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Self-Reported Hospital admissions in the past 30 days using Timeline Follow Back |
Baseline, 1, 3, and 6 months
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Emergency Department Visits in the Past 30 days
Временное ограничение: 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
|
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Urgent Care Visits in the Past 30 Days
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
Временное ограничение: immediately after the intervention (12 weeks from randomization)
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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)
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INSPIRE Appropriateness assessed via 4-item Appropriateness of Intervention Measure (AIM)
Временное ограничение: immediately after the intervention (12 weeks from randomization)
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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)
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Reach of the Intervention Over the Entire Study Period
Временное ограничение: Measured starting from the first randomization and ending after the final participant is randomized (up to 100 weeks after first randomization)
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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)
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Sustainment of intervention
Временное ограничение: Measured between 12 weeks (end of intervention) and 24 weeks after randomization
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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
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Feasibility
Временное ограничение: 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)
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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)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Michael A Incze, MD, University of Utah
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB_00204022
- 1R21DA066520-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
Сроки обмена IPD
Data will be available within 12 months of study conclusion
Критерии совместного доступа к 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .