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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.
The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth-CR | Experimental | Participants in this arm will receive the mHealth-CR intervention. |
|
| Usual Care | No Intervention | Participants in this arm receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth-CR | Other | Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute Walking Distance (6MWD) | Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse. The outcome change in 6MWD is calculated as 3 month 6MWD minus baseline 6MWD. | Baseline, 3 months |
| Number of Participants in Each Engagement Phenotype on Intervention Arm | Weekly engagement will be measured as the fraction of the following 11 elements completed each week: (1-7) daily entry of exercise data and relative perceived exertion (RPE); (8) completed weekly phone call with exercise therapist; (9) at least one electronic communication with exercise therapist; (10) watching educational video (which will vary by week); and (11) at least one home BP measurement. Engagement will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all 11 activities completed). The participants in the intervention arm will be grouped into 3 engagement phenotypes based on their scores: 1) Persistently Low, 2) Intermediate Declining, and 3) Persistently High. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS) | Using the SMART goal framework, GAS describes the person's expected level of goal achievement over 3 months, ranging from no change (scored as -2) to much better than expected (scored as +2) out of a 5 point-scale. Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. Overall score is calculated by incorporating the goal of outcomes scores into an aggregated t-score. Goal attainment, through goal setting, is an especially important outcome in older adults who may begin an intervention with a variety of deficits (therefore necessitating individualized therapy towards realistic goals). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Dodson, MD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | United States | ||
| NYU Langone Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41435373 | Derived | Barua S, Upadhyay D, Pena S, McConnell R, Varghese A, Adhikari S, LeRoy E, Schoenthaler A, Dodson JA. Adherence to Accelerometer Use in Older Adults Undergoing mHealth Cardiac Rehabilitation: Secondary Analysis of a Randomized Clinical Trial. J Med Internet Res. 2025 Dec 23;27:e80522. doi: 10.2196/80522. | |
| 41231194 | Derived |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Requests should be directed to john.dodson@nyumc.org. To gain access, data requestors will need to sign a data access agreement. The investigator who proposed to use the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | mHealth-CR | Participants in this arm will receive the mHealth-CR intervention. mHealth-CR: Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device. |
| FG001 | Usual Care | Participants in this arm receive usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | mHealth-CR | Participants in this arm will receive the mHealth-CR intervention. mHealth-CR: Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 6-minute Walking Distance (6MWD) | Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse. The outcome change in 6MWD is calculated as 3 month 6MWD minus baseline 6MWD. | Posted | Mean | Standard Deviation | meters | Baseline, 3 months |
|
Adverse Events monitored/assessed for 3 months. All-Cause Mortality monitored/assessed through follow up, up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mHealth-CR | Participants in this arm will receive the mHealth-CR intervention. mHealth-CR: Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac related events (Chest pain, planned procedure, and other) | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Dodson, MD | NYU Langone Health | 6465012714 | john.dodson@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2023 | May 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2023 | Mar 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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partial mask (outcomes assessor)
|
| 3 months |
| 12-Item Short Form Survey (SF-12) Score | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. For the SF-12, the 3 month score will be analyzed using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change. | Month 3 |
| Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status) | The Seattle Angina Questionnaire-7 (SAQ-7) is a self-administered questionnaire that measures patient-reported health measures related to coronary artery disease (CAD). The SAQ-7 is scored from 0 to 100, with higher scores indicating better health status, less frequent angina, and better quality of life (0-24: Poor health status; 25-49: Fair; 50-74: Good; 75-100: Excellent). For SAQ-7, we will analyze at a single time point (3 months) the number of participants who have residual angina (SAQ-7<100) vs. no angina (SAQ-7=100). | Baseline, 3 months |
| Percentage of Participants Who Have Any ADL or IADL Impairment | Defined as any improvement or worsening in basic (BADLs) or instrumental (IADLs) over 3 months. The Bristol Activities of Daily Living Scale (BADL) measures basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. The score is interpreted based on the total score, which ranges from 0 to 60. Higher scores indicate greater independence in daily living activities. The Lawton Instrumental Activities of Daily Living (IADL) scale measures activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping). The total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. | Baseline, 3 months |
| Number of Hospital Readmissions | Defined as number of participants who were readmitted into the hospital with an overnight stay (including observation) in any hospital within 12 months of hospitalization. Data are obtainable via the electronic health record (EHR). | 1 Year |
| Number of Participants Who Died From Any Cause | Data are obtainable via the electronic health record (EHR). | 1 Year |
| New York |
| New York |
| 10016 |
| United States |
| Shwayder EM, Dodson JA, Adhikari S, Grant EV, Schoenthaler AM, Pena S, Meng Y, Jennings LA. Goal Attainment Among Older Adults With Ischemic Heart Disease Using Mobile-Health Cardiac Rehabilitation in RESILIENT. JACC Adv. 2025 Dec;4(12 Pt 1):102298. doi: 10.1016/j.jacadv.2025.102298. Epub 2025 Nov 12. |
| 39775808 | Derived | Dodson JA, Adhikari S, Schoenthaler A, Hochman JS, Sweeney G, George B, Marzo K, Jennings LA, Kovell LC, Vorsanger M, Pena S, Meng Y, Varghese A, Johanek C, Rojas M, McConnell R, Whiteson J, Troxel AB. Rehabilitation at Home Using Mobile Health for Older Adults Hospitalized for Ischemic Heart Disease: The RESILIENT Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2453499. doi: 10.1001/jamanetworkopen.2024.53499. |
| 35238793 | Derived | Dodson JA, Schoenthaler A, Sweeney G, Fonceva A, Pierre A, Whiteson J, George B, Marzo K, Drewes W, Rerisi E, Mathew R, Aljayyousi H, Chaudhry SI, Hajduk AM, Gill TM, Estrin D, Kovell L, Jennings LA, Adhikari S. Rehabilitation Using Mobile Health for Older Adults With Ischemic Heart Disease in the Home Setting (RESILIENT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 3;11(3):e32163. doi: 10.2196/32163. |
| Adverse Event |
|
| BG001 | Usual Care | Participants in this arm receive usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Participants in this arm receive usual care. |
|
|
| Primary | Number of Participants in Each Engagement Phenotype on Intervention Arm | Weekly engagement will be measured as the fraction of the following 11 elements completed each week: (1-7) daily entry of exercise data and relative perceived exertion (RPE); (8) completed weekly phone call with exercise therapist; (9) at least one electronic communication with exercise therapist; (10) watching educational video (which will vary by week); and (11) at least one home BP measurement. Engagement will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all 11 activities completed). The participants in the intervention arm will be grouped into 3 engagement phenotypes based on their scores: 1) Persistently Low, 2) Intermediate Declining, and 3) Persistently High. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS) | Using the SMART goal framework, GAS describes the person's expected level of goal achievement over 3 months, ranging from no change (scored as -2) to much better than expected (scored as +2) out of a 5 point-scale. Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. Overall score is calculated by incorporating the goal of outcomes scores into an aggregated t-score. Goal attainment, through goal setting, is an especially important outcome in older adults who may begin an intervention with a variety of deficits (therefore necessitating individualized therapy towards realistic goals). | Posted | Number | Percentage of participants | 3 months |
|
|
|
| Secondary | 12-Item Short Form Survey (SF-12) Score | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. For the SF-12, the 3 month score will be analyzed using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Secondary | Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status) | The Seattle Angina Questionnaire-7 (SAQ-7) is a self-administered questionnaire that measures patient-reported health measures related to coronary artery disease (CAD). The SAQ-7 is scored from 0 to 100, with higher scores indicating better health status, less frequent angina, and better quality of life (0-24: Poor health status; 25-49: Fair; 50-74: Good; 75-100: Excellent). For SAQ-7, we will analyze at a single time point (3 months) the number of participants who have residual angina (SAQ-7<100) vs. no angina (SAQ-7=100). | Posted | Number | Percentage of participants | Baseline, 3 months |
|
|
|
| Secondary | Percentage of Participants Who Have Any ADL or IADL Impairment | Defined as any improvement or worsening in basic (BADLs) or instrumental (IADLs) over 3 months. The Bristol Activities of Daily Living Scale (BADL) measures basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. The score is interpreted based on the total score, which ranges from 0 to 60. Higher scores indicate greater independence in daily living activities. The Lawton Instrumental Activities of Daily Living (IADL) scale measures activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping). The total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. | Posted | Number | percentage of participants | Baseline, 3 months |
|
|
|
| Secondary | Number of Hospital Readmissions | Defined as number of participants who were readmitted into the hospital with an overnight stay (including observation) in any hospital within 12 months of hospitalization. Data are obtainable via the electronic health record (EHR). | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Secondary | Number of Participants Who Died From Any Cause | Data are obtainable via the electronic health record (EHR). | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| 5 |
| 298 |
| 19 |
| 298 |
| 64 |
| 298 |
| EG001 | Usual Care | Participants in this arm receive usual care. | 1 | 102 | 4 | 102 | 18 | 102 |
| Abnormal labs | Investigations | Non-systematic Assessment |
|
| Urinary obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| Planned procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Cancer | Immune system disorders | Non-systematic Assessment |
|
| Dizziness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| COVID | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| GI Issues | Gastrointestinal disorders | Non-systematic Assessment |
|
| Difficulty Swallowing | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest pain, tightness, angina | Cardiac disorders | Non-systematic Assessment |
|
| Planned procedure | Cardiac disorders | Non-systematic Assessment |
|
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Arrythmia, claudication, hypertensive or hypotensive urgency | Cardiac disorders | Non-systematic Assessment |
|
| Body pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Other events | Investigations | Non-systematic Assessment |
|
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