cardiovascular disease
Conditions
Interventions
Name: Personalized JITAI smartphone intervention plus wrist-worn wearable Category: Behavioral (digital health), device use Exposure window: 4 weeks during Phase B (Phase A is 2-week observation wit
notifications are turned off for 2-week post-B follow-up) Components: A JITAI smartphone app delivers 0 to 3 prompts per day, tailored by real-time activity and baseline personality assessment (TI
no scheduled human coaching during the intervention Comparator: Within-subject self-control. Weekly means during Phase A (observation, no notifications) are compared with Phase B (intervention)
Sponsors
Nagoya Aoi University
Nagoya City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Recruiting patients with stable cardiovascular disease who live in the local area (and have not been hospitalized for at least 12 months) Inclusion Criteria 1. Smartphone user who routinely uses the communication app LINE 2. Independent in activities of daily living 3. Agrees to wear a wearable device
Exclusion criteria
Exclusion criteria: 1. Patients with dementia 2. Patients with atrial fibrillation (as Fitbit pulse measurements may be inaccurate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean daily sedentary time (min/day) Timing: compare the last week of Phase A (pre-intervention, Week 2) with the last week of Phase B (after 4 weeks of intervention, Week 6); data source: Fitbit API, synced daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sum of >= 30-minute prolonged sitting (min/day): change in weekly means between end of Phase A (Week 2) and end of Phase B (Week 6). Sum of prolonged sitting >= 30 minutes (min/day): change in weekly means between end of Phase A (Week 2) and end of Phase B (Week 6). Sit-to-stand counts (counts/day): same timing. Steps (steps/day): same timing. Resting heart rate (bpm): change from end of Phase A to end of Phase B, plus maintenance at 2 weeks after Phase B (Week 8; notification-off follow-up). Implementation / acceptability: app launches (per day; averaged across 4 weeks of Phase B) and wear adherence (%; proportion of prescribed wear time from 09:00 to 21:00). Patient-reported outcomes (PROs): KCCQ-12 (total and domain scores) and fatigue VAS at registration, weekly, and 2 weeks after Phase B (Week 8). User experience: SUS score and a semi-structured interview at the end of Phase B (Week 6). Safety: frequency and severity of adverse events (exercise-related, cardiovascular, device-related, skin irritation). Cumulative from start of Phase A through end of follow-up (Week 8); Phase B breakdown as needed. | — |
Countries
Japan
Contacts
Public ContactKoichi Naito
Nagoya Aoi University Department of Physical Therapy, Faculty of Medical Science
Outcome results
None listed