Ischemic Heart Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Masking description
partial mask (outcomes assessor)
Eligibility
Inclusion criteria
1. Age ≥65 2. Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks. 3. Capable of self-consent. 4. Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).
Exclusion criteria
1. Non-ambulatory. 2. Moderate or severe cognitive impairment. 3. Unable/unwilling to consent. 4. PCI-related groin hematoma that precludes brisk walking. 5. Incarcerated. 6. Unable to use mHealth software in English or Spanish. 7. Severe osteoarthritis, or joint replacement within last 3 months. 8. Parkinson's disease or other progressive movement disorder. 9. Regular use of walker for ambulation. 10. Projected life expectancy \<3 months. 11. Clinical judgment concerning other safety or nonadherence issues. 12. Participants admitted from long-term care facility. 13. Currently listed for heart transplant. 14. Left ventricular assist device recipient. 15. Completion of ambulatory cardiac rehabilitation program within prior 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute Walking Distance (6MWD) | Baseline, 3 months | 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. |
| Number of Participants in Each Engagement Phenotype on Intervention Arm | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status) | Baseline, 3 months | 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). |
| Percentage of Participants Who Have Any ADL or IADL Impairment | Baseline, 3 months | 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. |
| Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS) | 3 months | 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). |
| Number of Participants Who Died From Any Cause | 1 Year | Data are obtainable via the electronic health record (EHR). |
| Number of Hospital Readmissions | 1 Year | 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). |
| 12-Item Short Form Survey (SF-12) Score | Month 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 298 |
| Usual Care Participants in this arm receive usual care. | 102 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 13 | 14 |
| Overall Study | Withdrawal by Subject | 12 | 2 |
Baseline characteristics
| Characteristic | mHealth-CR | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 71 years | 71 years | 71 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 34 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 366 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 36 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 31 Participants | 44 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 229 Participants | 303 Participants | 74 Participants |
| Region of Enrollment United States | 298 participants | 400 participants | 102 participants |
| Sex: Female, Male Female | 82 Participants | 109 Participants | 27 Participants |
| Sex: Female, Male Male | 216 Participants | 291 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 298 | 1 / 102 |
| other Total, other adverse events | 64 / 298 | 18 / 102 |
| serious Total, serious adverse events | 19 / 298 | 4 / 102 |
Outcome results
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth-CR | Change in 6-minute Walking Distance (6MWD) | 41.2 meters | Standard Deviation 1.5 |
| Usual Care | Change in 6-minute Walking Distance (6MWD) | 25.6 meters | Standard Deviation 2.7 |
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mHealth-CR | Number of Participants in Each Engagement Phenotype on Intervention Arm | 81 Participants |
| Usual Care | Number of Participants in Each Engagement Phenotype on Intervention Arm | 93 Participants |
| Persistently High | Number of Participants in Each Engagement Phenotype on Intervention Arm | 124 Participants |
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.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mHealth-CR | 12-Item Short Form Survey (SF-12) Score | 46.3 score on a scale | Standard Deviation 1 |
| Usual Care | 12-Item Short Form Survey (SF-12) Score | 48.2 score on a scale | Standard Deviation 1.1 |
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).
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mHealth-CR | Number of Hospital Readmissions | 56 Participants |
| Usual Care | Number of Hospital Readmissions | 16 Participants |
Number of Participants Who Died From Any Cause
Data are obtainable via the electronic health record (EHR).
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mHealth-CR | Number of Participants Who Died From Any Cause | 5 Participants |
| Usual Care | Number of Participants Who Died From Any Cause | 1 Participants |
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mHealth-CR | Percentage of Participants Who Have Any ADL or IADL Impairment | 9.7 percentage of participants |
| Usual Care | Percentage of Participants Who Have Any ADL or IADL Impairment | 10.6 percentage of participants |
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).
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mHealth-CR | Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS) | 25.7 Percentage of participants |
| Usual Care | Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS) | 20.9 Percentage of participants |
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).
Time frame: Baseline, 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mHealth-CR | Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status) | 25.7 Percentage of participants |
| Usual Care | Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status) | 20.9 Percentage of participants |