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Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease

REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03978130
Acronym
RESILIENT
Enrollment
400
Registered
2019-06-06
Start date
2020-01-09
Completion date
2024-04-30
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

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

National Institutes of Health (NIH)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

partial mask (outcomes assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 110 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change in 6-minute Walking Distance (6MWD)Baseline, 3 monthsChange 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 Arm3 monthsWeekly 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

MeasureTime frameDescription
Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status)Baseline, 3 monthsThe 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 ImpairmentBaseline, 3 monthsDefined 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 monthsUsing 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 Cause1 YearData are obtainable via the electronic health record (EHR).
Number of Hospital Readmissions1 YearDefined 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) ScoreMonth 3The 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

ArmCount
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
Total400

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event21
Overall StudyLost to Follow-up1314
Overall StudyWithdrawal by Subject122

Baseline characteristics

CharacteristicmHealth-CRTotalUsual Care
Age, Continuous71 years71 years71 years
Ethnicity (NIH/OMB)
Hispanic or Latino
23 Participants34 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
275 Participants366 Participants91 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
11 Participants17 Participants6 Participants
Race (NIH/OMB)
Black or African American
27 Participants36 Participants9 Participants
Race (NIH/OMB)
More than one race
31 Participants44 Participants13 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
229 Participants303 Participants74 Participants
Region of Enrollment
United States
298 participants400 participants102 participants
Sex: Female, Male
Female
82 Participants109 Participants27 Participants
Sex: Female, Male
Male
216 Participants291 Participants75 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 2981 / 102
other
Total, other adverse events
64 / 29818 / 102
serious
Total, serious adverse events
19 / 2984 / 102

Outcome results

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.

Time frame: Baseline, 3 months

ArmMeasureValue (MEAN)Dispersion
mHealth-CRChange in 6-minute Walking Distance (6MWD)41.2 metersStandard Deviation 1.5
Usual CareChange in 6-minute Walking Distance (6MWD)25.6 metersStandard Deviation 2.7
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.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mHealth-CRNumber of Participants in Each Engagement Phenotype on Intervention Arm81 Participants
Usual CareNumber of Participants in Each Engagement Phenotype on Intervention Arm93 Participants
Persistently HighNumber of Participants in Each Engagement Phenotype on Intervention Arm124 Participants
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.

Time frame: Month 3

ArmMeasureValue (MEAN)Dispersion
mHealth-CR12-Item Short Form Survey (SF-12) Score46.3 score on a scaleStandard Deviation 1
Usual Care12-Item Short Form Survey (SF-12) Score48.2 score on a scaleStandard Deviation 1.1
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).

Time frame: 1 Year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mHealth-CRNumber of Hospital Readmissions56 Participants
Usual CareNumber of Hospital Readmissions16 Participants
Secondary

Number of Participants Who Died From Any Cause

Data are obtainable via the electronic health record (EHR).

Time frame: 1 Year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mHealth-CRNumber of Participants Who Died From Any Cause5 Participants
Usual CareNumber of Participants Who Died From Any Cause1 Participants
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.

Time frame: Baseline, 3 months

ArmMeasureValue (NUMBER)
mHealth-CRPercentage of Participants Who Have Any ADL or IADL Impairment9.7 percentage of participants
Usual CarePercentage of Participants Who Have Any ADL or IADL Impairment10.6 percentage of participants
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).

Time frame: 3 months

ArmMeasureValue (NUMBER)
mHealth-CRPercentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)25.7 Percentage of participants
Usual CarePercentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)20.9 Percentage of participants
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).

Time frame: Baseline, 3 months

ArmMeasureValue (NUMBER)
mHealth-CRPercentage 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 CarePercentage 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

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026