Trial Outcomes & Findings for Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE) (NCT NCT04938661)
NCT ID: NCT04938661
Last Updated: 2026-04-27
Results Overview
The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
206 participants
Primary outcome timeframe
Baseline; 3 Months
Results posted on
2026-04-27
Participant Flow
Participant milestones
| Measure |
Conventional Center-Based Cardiac Rehab (CON)
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
Home-Based Cardiac Rehab + mHealth (HOM+)
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
67
|
68
|
|
Overall Study
COMPLETED
|
54
|
53
|
38
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
30
|
Reasons for withdrawal
| Measure |
Conventional Center-Based Cardiac Rehab (CON)
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
Home-Based Cardiac Rehab + mHealth (HOM+)
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
22
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Could Note Tolerate
|
2
|
1
|
0
|
|
Overall Study
Hospitalization/New CV Event
|
5
|
1
|
3
|
Baseline Characteristics
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Baseline characteristics by cohort
| Measure |
Conventional Center-Based Cardiac Rehab (CON)
n=71 Participants
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
n=67 Participants
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
Home-Based Cardiac Rehab + mHealth (HOM+)
n=68 Participants
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 10.76 • n=226 Participants
|
63.2 years
STANDARD_DEVIATION 14.16 • n=240 Participants
|
63.6 years
STANDARD_DEVIATION 11.04 • n=236 Participants
|
63.6 years
STANDARD_DEVIATION 12.00 • n=702 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=226 Participants
|
18 Participants
n=240 Participants
|
19 Participants
n=236 Participants
|
58 Participants
n=702 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=226 Participants
|
49 Participants
n=240 Participants
|
49 Participants
n=236 Participants
|
148 Participants
n=702 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
2 Participants
n=236 Participants
|
4 Participants
n=702 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=226 Participants
|
59 Participants
n=240 Participants
|
60 Participants
n=236 Participants
|
180 Participants
n=702 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=226 Participants
|
7 Participants
n=240 Participants
|
6 Participants
n=236 Participants
|
22 Participants
n=702 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
2 Participants
n=702 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=226 Participants
|
3 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
5 Participants
n=702 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=226 Participants
|
63 Participants
n=240 Participants
|
66 Participants
n=236 Participants
|
197 Participants
n=702 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=226 Participants
|
0 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
2 Participants
n=702 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=226 Participants
|
67 participants
n=240 Participants
|
68 participants
n=236 Participants
|
206 participants
n=702 Participants
|
PRIMARY outcome
Timeframe: Baseline; 3 MonthsPopulation: 10 participants in the CON arm, 9 participants in the CON+ arm and 1 participant in the HOM+ did not complete the METS measurement at the 3-month mark.
The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure.
Outcome measures
| Measure |
Home-Based Cardiac Rehab + mHealth (HOM+)
n=37 Participants
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
Conventional Center-Based Cardiac Rehab (CON)
n=44 Participants
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
n=44 Participants
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
|---|---|---|---|
|
Change in Metabolic Equivalents of Task (METS)
|
7.43 mL/kg/min
Interval 6.3 to 8.8
|
6.48 mL/kg/min
Interval 5.2 to 7.6
|
7.40 mL/kg/min
Interval 5.68 to 8.35
|
PRIMARY outcome
Timeframe: 1 YearThe number of participants who were re-hospitalized during the trial.
Outcome measures
| Measure |
Home-Based Cardiac Rehab + mHealth (HOM+)
n=38 Participants
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
Conventional Center-Based Cardiac Rehab (CON)
n=54 Participants
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
n=53 Participants
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
|---|---|---|---|
|
Number of Participants Who Were Re-hospitalized During the Trial
|
11 Participants
|
19 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 MonthsThe percentage of completed visits per participant that were attended from the start of the intervention (baseline) to the end of the intervention (3 months) relative to the number of prescribed visits per participant.
Outcome measures
| Measure |
Home-Based Cardiac Rehab + mHealth (HOM+)
n=68 Participants
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
Conventional Center-Based Cardiac Rehab (CON)
n=71 Participants
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
n=67 Participants
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
|---|---|---|---|
|
Adherence to the Intervention
|
100 percentage of completed visits
Interval 16.7 to 108.3
|
66.7 percentage of completed visits
Interval 30.6 to 95.8
|
88.0 percentage of completed visits
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; 3 MonthsPopulation: 2 participants in the CON arm and 2 participants in the CON+ arm did not complete the BMI measurement at the baseline mark. 9 participants in the CON arm, 12 participants in the CON+ arm and 3 participants in the HOM+ arm did not complete the BMI measurement at the 3-month mark.
The change in body mass index (BMI) measured from baseline to 3 months.
Outcome measures
| Measure |
Home-Based Cardiac Rehab + mHealth (HOM+)
n=38 Participants
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
Conventional Center-Based Cardiac Rehab (CON)
n=52 Participants
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
n=51 Participants
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
|---|---|---|---|
|
Change in Body Mass Index
3 Months
|
26.8 kg/m^2
Interval 24.3 to 31.2
|
30.0 kg/m^2
Interval 27.0 to 34.2
|
28.4 kg/m^2
Interval 25.5 to 32.4
|
|
Change in Body Mass Index
Baseline
|
28.5 kg/m^2
Interval 24.5 to 31.7
|
29.1 kg/m^2
Interval 26.8 to 35.8
|
29.5 kg/m^2
Interval 25.8 to 32.6
|
SECONDARY outcome
Timeframe: Baseline; 3 MonthsPopulation: 10 participants in the CON arm, 12 participants in the CON+ arm and 7 participants in the HOM+ arm did not complete the PHQ-9 at the baseline mark. 30 participants in the CON arm, 32 participants in the CON+ arm and 8 participants in the HOM+ arm did not complete the PHQ-9 at the 3-month mark.
The change in self-reported quality of life assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Outcome measures
| Measure |
Home-Based Cardiac Rehab + mHealth (HOM+)
n=31 Participants
Participants were provided paper copies of educational content at the time of event/discharge. In addition, these participants were provided access to the same mHealth platform as the CON+ group. Participants in this group were encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation were tracked using web/internet analytics.
mHealth: Mobile Health Platform
Home-Based Cardiac Rehab: Encouraged to exercise 3 times per week at home
|
Conventional Center-Based Cardiac Rehab (CON)
n=44 Participants
Participants were prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants had direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
|
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
n=41 Participants
Participants were prescribed 36 sessions of center-based CR as noted above. In addition, participants were provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module allowed patients to communicate via secure network with other patients who were part of their invited network. The Social Network Module also allowed for secure two-way interaction with healthcare providers in the event that patients were experiencing signs or symptoms suggestive of worsening condition. This platform also contained a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
Center-Based Cardiac Rehab: 36 center-Based Cardiac Rehab Sessions
mHealth: Mobile Health Platform
|
|---|---|---|---|
|
Change in Self-Reported Quality of Life
Baseline
|
1.0 score on a scale
Interval 0.0 to 3.0
|
2.5 score on a scale
Interval 0.5 to 5.5
|
3.0 score on a scale
Interval 1.0 to 4.0
|
|
Change in Self-Reported Quality of Life
3 Months
|
0.0 score on a scale
Interval 0.0 to 2.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
Adverse Events
Conventional Center-Based Cardiac Rehab (CON)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Center-Based Cardiac Rehab + mHealth (CON+)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home-Based Cardiac Rehab + mHealth (HOM+)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place