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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michael A Incze, MD
- 電話番号：801-581-2000
- メール：Michael.Incze@hsc.utah.edu
研究場所
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84108
- 募集
- University of Utah Health
-
コンタクト：
- Michael A Incze, MD
- 電話番号：801-581-2000
- メール：Michael.Incze@hsc.utah.edu
-
コンタクト：
- Dominique Ingram
- 電話番号：801-581-2000
- メール：dominique.ingram@utah.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in metabolic equivalents (METs)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life - Short Form 20
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
INSPIRE Acceptability assessed via 4-item Intervention Acceptability Measure (IAM)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael A Incze, MD、University of Utah
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB_00204022
- 1R21DA066520-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Data will be available within 12 months of study conclusion
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。