HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management
Effect of HeartMate Application-Based Remote Patient Monitoring on Cardiovascular Risk Factor Management: An Exploratory Randomized Controlled Pilot Study
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Study design: This is a single-center, prospective, open-label, randomized controlled exploratory pilot trial with two parallel groups and 1:1 allocation. A total of 200 participants (100 per group) are planned, with approximately 170 evaluable participants expected after an anticipated 10-20% dropout.
Background and rationale: Traditional hospital-based cardiac rehabilitation has low participation because of travel, time, and cost barriers. Smartphone-based remote patient monitoring and digital cardiac rehabilitation may lower these barriers and enable continuous monitoring of cardiovascular risk factors. Smartphone-derived digital biomarkers, including remote photoplethysmography (rPPG) and heart rate variability (HRV), may provide non-invasive markers correlated with conventional cardiovascular risk indicators.
Randomization: After completion of baseline assessment, participants are randomly allocated 1:1 to the intervention or control group using a random number table with block randomization (block size of 4). The allocation sequence is generated by a person independent of the study, and allocation is concealed using sequentially numbered, password-protected locked files. Investigators performing screening and enrollment do not have access to the allocation sequence.
Intervention group: Participants use the HeartMate app-based remote cardiac rehabilitation program for 6 weeks. The program provides a daily heart check using rPPG, aerobic and resistance exercise, breathing training, and a cognitive-behavioral mind program. Trained staff provide message-based counseling and exercise and lifestyle guidance at least weekly; the Severance research team reviews monitoring logs at least weekly and handles all medical decisions and adverse events.
Control group: Participants receive usual outpatient follow-up and lifestyle education materials. The HeartMate app is installed for rPPG-based measurement only, with no exercise or mind program, so that digital-biomarker measurement is identical across groups and to minimize confounding from app installation.
Assessments: Clinical assessments (6-minute walk distance, grip strength, blood pressure, height, weight, electrocardiogram), blood tests (lipid profile, fasting glucose, renal and hepatic function, electrolytes; HbA1c for participants with diabetes; NT-proBNP for participants with heart failure), questionnaires (SF-12, PHQ-9, GAD-7, KOSS-24), and digital biomarkers (rPPG-derived heart rate, HRV, respiration, activity; reference contact PPG for accuracy verification) are collected at baseline and at 6 weeks. Standardized measurement conditions are applied for rPPG (fasting, seated stable posture, camera distance 30-50 cm, uniform lighting, repeated measurement, and signal-quality control).
Outcomes: The primary outcome is the between-group difference in the change in 6-minute walk distance from baseline to 6 weeks, analyzed primarily by independent-samples t-test (exploratory) with ANCOVA as a supportive analysis adjusting for baseline and covariates. Secondary outcomes include safety (adverse events and serious adverse events) and adherence (app usage days and target usage rate of at least 80%). Exploratory outcomes include changes in blood pressure, blood lipids, glucose and HbA1c, quality of life and psychological measures, and the agreement between rPPG-derived and reference contact-PPG digital biomarkers.
Statistical considerations: As an exploratory pilot, the sample size is intended to provide reliable preliminary estimates (effect size, standard deviation, dropout rate) for a future definitive randomized controlled trial rather than to confirm efficacy. Analyses follow the intention-to-treat principle, with missing data handled per the statistical analysis plan.
Data management: Data are identified only by a unique subject code and stored on an encrypted secure server (AES-256 encryption; FIPS 140-3 physical and logical security). rPPG facial video is not stored; only de-identified RGB time-series signals are retained. Records are kept for 3 years after study completion and then destroyed irrecoverably.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Chan Joo Lee, Professor
- Telefonnummer: +82-2-2228-8460
- E-post: zanzu@yuhs.ac
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Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Adults aged 19 years or older
- Patients with cardiac disease judged to require cardiac rehabilitation (e.g., heart failure, valvular heart disease, coronary artery disease, peripheral arterial disease)
- Able to be followed for at least 6 weeks during the study period
- Able to consent to blood testing and PPG measurement at baseline and endpoint
- Able to use a smartphone application
Exclusion Criteria:
- Judged unable to undergo PPG measurement
- Atrial fibrillation
- Condition or disease making participation in cardiac rehabilitation difficult
- Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention Group (HeartMate App-Based Remote Cardiac Rehabilitation)
Participants use the HeartMate app-based remote cardiac rehabilitation program for 6 weeks (daily rPPG heart check; aerobic and resistance exercise; breathing training; cognitive-behavioral mind program), with at least weekly remote coaching.
|
A 6-week smartphone application program delivering a daily heart check using remote photoplethysmography (rPPG), aerobic and resistance exercise, breathing training, and a cognitive-behavioral mind program.
Trained staff provide message-based counseling and exercise/lifestyle guidance at least weekly, and the Severance research team reviews monitoring logs at least weekly and handles all medical decisions and adverse events.
|
|
Placebo-jämförare: Control Group (Usual Care with App-Based Measurement Only)
Participants receive usual outpatient follow-up and lifestyle education materials.
The HeartMate app is installed for rPPG-based measurement only (no exercise or mind program) to keep digital-biomarker measurement identical across groups.
|
Standard outpatient follow-up and lifestyle education materials without the exercise or mind program.
The HeartMate app is installed solely for rPPG-based digital-biomarker measurement at baseline and at 6 weeks, ensuring identical measurement conditions across groups.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 6 Weeks
Tidsram: Baseline and 6 weeks (change from baseline to Week 6)
|
The distance walked (in meters) during the 6-minute walk test, measured at baseline and at 6 weeks.
The change (Week 6 minus baseline) is compared between the intervention and control groups.
As an exploratory pilot outcome, the primary purpose is to estimate the effect size and standard deviation for a future randomized controlled trial rather than to confirm efficacy.
|
Baseline and 6 weeks (change from baseline to Week 6)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With At Least One Adverse Event (AE)
Tidsram: From randomization through 6 weeks
|
Number of participants with at least one adverse event during the intervention period.
Unit of measure: participants (count).
|
From randomization through 6 weeks
|
|
Number of Participants With At Least One Serious Adverse Event (SAE)
Tidsram: From randomization through 6 weeks
|
Number of participants with at least one serious adverse event during the intervention period.
Unit of measure: participants (count).
|
From randomization through 6 weeks
|
|
Proportion of Participants Achieving Target Application Usage (>= 80%)
Tidsram: Over the 6-week intervention period
|
Percentage of intervention-group participants whose HeartMate application usage reaches at least 80% of the prescribed daily sessions.
Unit of measure: percentage of participants (%).
A higher value indicates better adherence.
|
Over the 6-week intervention period
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in resting systolic blood pressure, measured after 5 minutes of rest using an automated sphygmomanometer.
Unit of measure: mmHg.
|
Baseline and 6 weeks
|
|
Change From Baseline in Diastolic Blood Pressure at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in resting diastolic blood pressure, measured after 5 minutes of rest using an automated sphygmomanometer.
Unit of measure: mmHg.
|
Baseline and 6 weeks
|
|
Change From Baseline in Total Cholesterol at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in serum total cholesterol.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
|
Change From Baseline in LDL Cholesterol at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in serum low-density lipoprotein (LDL) cholesterol.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
|
Change From Baseline in HDL Cholesterol at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in serum high-density lipoprotein (HDL) cholesterol.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
|
Change From Baseline in Triglycerides at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in serum triglycerides.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
|
Change From Baseline in Fasting Plasma Glucose at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in fasting plasma glucose.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in glycated hemoglobin (HbA1c).
Unit of measure: percent (%).
|
Baseline and 6 weeks
|
|
Change From Baseline in SF-12 Physical Component Summary at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12).
Scores range from 0 to 100; higher scores indicate better physical health-related quality of life.
Unit of measure: units on a scale.
(The exact minimum and maximum depend on the SF-12 scoring algorithm used.)
|
Baseline and 6 weeks
|
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Change From Baseline in SF-12 Mental Component Summary at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in the Mental Component Summary (MCS) of the 12-Item Short-Form Health Survey (SF-12).
Scores range from 0 to 100; higher scores indicate better mental health-related quality of life.
Unit of measure: units on a scale.
(The exact minimum and maximum depend on the SF-12 scoring algorithm used.)
|
Baseline and 6 weeks
|
|
Change From Baseline in PHQ-9 Total Score at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in the Patient Health Questionnaire-9 (PHQ-9) total score.
Total score ranges from 0 to 27; higher scores indicate more severe depressive symptoms (a worse outcome).
Unit of measure: units on a scale.
|
Baseline and 6 weeks
|
|
Change From Baseline in GAD-7 Total Score at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in the Generalized Anxiety Disorder-7 (GAD-7) total score.
Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms (a worse outcome).
Unit of measure: units on a scale.
|
Baseline and 6 weeks
|
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Change From Baseline in KOSS-SF Total Score at 6 Weeks
Tidsram: Baseline and 6 weeks
|
Change from baseline to 6 weeks in the Korean Occupational Stress Scale - Short Form (KOSS-SF, 24 items).
Item scores are converted to a 0 to 100 scale; higher scores indicate greater occupational stress (a worse outcome).
Unit of measure: units on a scale.
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Baseline and 6 weeks
|
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Mean Absolute Error Between rPPG- and Reference Contact PPG-Derived Heart Rate
Tidsram: Baseline and 6 weeks
|
Mean absolute error between heart rate derived from smartphone remote photoplethysmography (rPPG) and simultaneously measured reference contact PPG.
Unit of measure: beats per minute (bpm).
Lower values indicate better agreement.
|
Baseline and 6 weeks
|
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Correlation Between rPPG- and Reference Contact PPG-Derived HRV (SDNN)
Tidsram: Baseline and 6 weeks
|
Pearson correlation coefficient between heart rate variability (SDNN) derived from rPPG and from reference contact PPG.
Unit of measure: correlation coefficient (r), ranging from -1 to 1; values closer to 1 indicate better agreement.
|
Baseline and 6 weeks
|
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- 4-2026-0449
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