心不全患者のための在宅心臓リハビリテーション (MOBILE HEART)
心不全患者向けのモバイルヘルスツールを使用した在宅心臓リハビリテーション (MOBILE HEART): ランダム化比較試験
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University Medical Center
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-
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 Roll-in Phase
-
Stage C HF (NYHA Class I-III) AND
- Discharged from a HF hospitalization OR
- Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
- Scheduled for appointment in a cardiology clinic with a KCCQ-SS <75
-
Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase
Randomized Controlled Trial (beyond roll-in phase)
1. Willingness to continue and participate in the study visits and other study activities required for the RCT
Exclusion Criteria Roll-in Phase
- Unwilling or unable to provide informed consent for participation in the RCT
- Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
- If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
- History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
- Age < 18 years
- Stage D HF (advanced HF under evaluation for LVAD or transplant)
- NYHA class IV symptoms
- Congenital heart disease
- Pregnant
- Group 1 pulmonary hypertension
- Moderate-severe or severe (> 3+) mitral or aortic valvular disease
- Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
- Planned surgery within 3 months
- Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
- Treating provider or study team physician indicates that participation in the RCT would be unsafe
- Participation in any ongoing randomized trial that has not completed follow-up
Randomized Controlled Trial (beyond roll-in phase)
- Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device >9 hours/day for at least 1 day.
- Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
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：Home-based cardiac rehabilitation mobile health intervention
Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets. |
Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist. |
|
介入なし：Control
Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living. |
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 |
|---|---|---|
|
Average daily total activity counts
時間枠：The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.
|
Daily total activity counts are determined by a triaxial actigraphy device. |
The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
血圧
時間枠：比較はランダム化後 12 週間で行われます。
|
比較はランダム化後 12 週間で行われます。
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|
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Average daily active minutes
時間枠：The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.
|
Daily active minutes are determined by a triaxial actigraphy device. |
The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.
|
|
Average daily steps
時間枠：The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
|
Daily steps are determined by a triaxial actigraphy device. |
The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
|
|
Average daily energy expenditure
時間枠：The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.
|
Average daily energy expenditure is determined by a triaxial actigraphy device. |
The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.
|
|
Average daily moderate to vigorous active minutes
時間枠：The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.
|
Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device. |
The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.
|
|
Sustained physical activity bursts of 10 minutes or greater per day
時間枠：The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
|
Physical activity bursts are determined by a triaxial actigraphy device. |
The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
|
|
6 minute walk distance
時間枠：The comparison will be at 12-weeks after randomization.
|
The distance walked in 6 minutes. |
The comparison will be at 12-weeks after randomization.
|
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Chair sit to stand time
時間枠：The comparison will be at 12-weeks after randomization.
|
The time taken to complete 5 chair rises. |
The comparison will be at 12-weeks after randomization.
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5 meter gait speed
時間枠：The comparison will be at 12-weeks after randomization.
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The speed of walking 5 meters (meters/second). |
The comparison will be at 12-weeks after randomization.
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Balance test
時間枠：The comparison will be at 12-weeks after randomization.
|
Score based on ability to stand unsupported for 10 seconds with feet in a certain position (feet together, semi tandem, full tandem). Score ranges from 0-4 (higher score is better). |
The comparison will be at 12-weeks after randomization.
|
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AM-PAC Basic Mobility Outpatient Short Form (Low Function)
時間枠：The comparison will be at 12-weeks after randomization.
|
Basic mobility will be assessed with the Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form (Low Function); (raw score range 0-39, higher score is better) |
The comparison will be at 12-weeks after randomization.
|
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Short Physical Performance Battery Score
時間枠：The comparison will be at 12-weeks after randomization.
|
Composite score including 3 components (Chair sit to stand, 5 meter gait speed, balance test). Score ranges from 0-12 (higher score is better). |
The comparison will be at 12-weeks after randomization.
|
|
Heart-failure specific health status assessed by the KCCQ
時間枠：The comparison will be at 12-weeks after randomization.
|
Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ); (score range 0-100, higher is better health status). |
The comparison will be at 12-weeks after randomization.
|
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Physical health status assessed by the PROMIS 10
時間枠：The comparison will be at 12-weeks after randomization.
|
Global physical health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20, higher is better). |
The comparison will be at 12-weeks after randomization.
|
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Mental health status assessed by the PROMIS 10
時間枠：The comparison will be at 12-weeks after randomization.
|
Global mental health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20, higher is better) |
The comparison will be at 12-weeks after randomization.
|
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Mood disturbance assessed by PHQ9
時間枠：The comparison will be at 12-weeks after randomization.
|
Patient health questionnaire 9 (PHQ9); (score range 1-27, lower is better) |
The comparison will be at 12-weeks after randomization.
|
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Behavioral Regulation In Exercise Questionnaire 3
時間枠：The comparison will be at 12-weeks after randomization.
|
Behavioral Regulation In Exercise Questionnaire 3 (BREQ-3); (score range per question of 0-4, higher is better). |
The comparison will be at 12-weeks after randomization.
|
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Social support and exercise survey
時間枠：The comparison will be at 12-weeks after randomization.
|
Social support and exercise survey (score range per question of 1-5, higher is better). |
The comparison will be at 12-weeks after randomization.
|
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Multidimensional Self-Efficacy for Exercise Scale
時間枠：The comparison will be at 12-weeks after randomization.
|
Multidimensional Self-Efficacy for Exercise Scale (MSES); (score range per question of 0-10, higher is better). |
The comparison will be at 12-weeks after randomization.
|
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General self-efficacy scale
時間枠：The comparison will be at 12-weeks after randomization.
|
General self-efficacy scale (GSE); (score range per question of 1-4, higher is better). |
The comparison will be at 12-weeks after randomization.
|
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Modified Heart Failure Collaborative GDMT score
時間枠：The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.
|
Guideline directed medical therapy (GDMT) score includes 4 components of RAASi, BB, SGLT2i, and MRA (maximum score of 9, higher scores indicate increased GDMT utilization). |
The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.
|
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Probability of the hierarchical clinical event composite
時間枠：Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death and (2) all-cause hospitalization. To examine whether the intervention improves mortality and hospitalization, in heart failure patients, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The active treatment vs. control group comparison (primary comparison for the trial) will be estimated by contrasting the average of posterior probability that Y≥y of the active treatment group to the control group. |
Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
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All-cause unplanned rehospitalization
時間枠：Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
This includes inpatient, observation, or ER visit. |
Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
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Worsening heart failure event
時間枠：Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
This includes inpatient, observation, ER visit, or urgent clinic visit for worsening heart failure. |
Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
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All-cause mortality
時間枠：Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
Death for any reason. |
Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
|
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"Thriving patient" composite
時間枠：The comparison will be made at 12 weeks.
|
Percent of patients that meet the following criteria: 1) alive 2) no all-cause hospitalization 3) Improvement in average daily total activity counts by 10% or greater from baseline to 12 weeks. |
The comparison will be made at 12 weeks.
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協力者と研究者
捜査官
- 主任研究者：Brian R Lindman, MD, MSCI、Vanderbilt University Medical Center
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
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