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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Chan Joo Lee, Professor
- Numéro de téléphone: +82-2-2228-8460
- E-mail: zanzu@yuhs.ac
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
|
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Comparateur placebo: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 6 Weeks
Délai: 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.
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Baseline and 6 weeks (change from baseline to Week 6)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With At Least One Adverse Event (AE)
Délai: From randomization through 6 weeks
|
Number of participants with at least one adverse event during the intervention period.
Unit of measure: participants (count).
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From randomization through 6 weeks
|
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Number of Participants With At Least One Serious Adverse Event (SAE)
Délai: 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
|
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Proportion of Participants Achieving Target Application Usage (>= 80%)
Délai: Over the 6-week intervention period
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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.
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Over the 6-week intervention period
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at 6 Weeks
Délai: 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
|
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Change From Baseline in Diastolic Blood Pressure at 6 Weeks
Délai: 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
|
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Change From Baseline in Total Cholesterol at 6 Weeks
Délai: Baseline and 6 weeks
|
Change from baseline to 6 weeks in serum total cholesterol.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
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Change From Baseline in LDL Cholesterol at 6 Weeks
Délai: 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
|
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Change From Baseline in HDL Cholesterol at 6 Weeks
Délai: 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
|
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Change From Baseline in Triglycerides at 6 Weeks
Délai: Baseline and 6 weeks
|
Change from baseline to 6 weeks in serum triglycerides.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
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Change From Baseline in Fasting Plasma Glucose at 6 Weeks
Délai: Baseline and 6 weeks
|
Change from baseline to 6 weeks in fasting plasma glucose.
Unit of measure: mg/dL.
|
Baseline and 6 weeks
|
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Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Weeks
Délai: Baseline and 6 weeks
|
Change from baseline to 6 weeks in glycated hemoglobin (HbA1c).
Unit of measure: percent (%).
|
Baseline and 6 weeks
|
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Change From Baseline in SF-12 Physical Component Summary at 6 Weeks
Délai: 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.)
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Baseline and 6 weeks
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Change From Baseline in SF-12 Mental Component Summary at 6 Weeks
Délai: 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
|
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Change From Baseline in PHQ-9 Total Score at 6 Weeks
Délai: 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
|
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Change From Baseline in GAD-7 Total Score at 6 Weeks
Délai: 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
Délai: 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.
|
Baseline and 6 weeks
|
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Mean Absolute Error Between rPPG- and Reference Contact PPG-Derived Heart Rate
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiaques
- Athérosclérose
- Artériosclérose
- Maladies artérielles occlusives
- Maladies vasculaires périphériques
- Maladie coronarienne
- Ischémie myocardique
- Insuffisance cardiaque
- Maladies cardiovasculaires
- Maladie artérielle périphérique
- Maladie de l'artère coronaire
- Maladies des valves cardiaques
- Insuffisance cardiaque, systolique
Autres numéros d'identification d'étude
- 4-2026-0449
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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