Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062037) titled 'An AB-design pilot study evaluating the effectiveness of a personalized smartphone intervention (JITAI) combined with a wearable device to optimize sedentary time in outpatients with heart disease' on June 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Nagoya Aoi University

Condition: Condition - cardiovascular disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to evaluate the feasibility and preliminary efficacy of an intervention combining a digital nudge-based JITAI app and wearable devices tailored to individual characteristics (TIPI-J) using a single-subject AB design targeting community-dwelling patients with stable cardiovascular disease, and to estimate the effect size to inform future RCT designs. The primary outcomes will be reductions in total daily sitting time and the cumulative duration of continuous sitting sessions lasting 30 minutes or longer. Secondary outcomes will include the number of times the participant stands up, step count, implementation and acceptability indicators (number of app launches, wear rate), patient-reported outcomes (KCCQ-12, fatigue VAS), and physiological indicators (resting heart rate). Safety will be assessed descriptively by monitoring the frequency of adverse events. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 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 without notifications; 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 (TIPI-J)

Prompts are triggered when prolonged sitting reaches 30 minutes or when overall activity is low, encouraging brief sit-to-stand and short walks

A wrist-worn wearable continuously captures daytime activity and syncs to the app Use instructions: Wear and run the app primarily from 09:00 to 21:00. Study staff provide onboarding and safety checks; 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)

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key 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 Key exclusion criteria - 1. Patients with dementia 2. Patients with atrial fibrillation (as Fitbit pulse measurements may be inaccurate) Target Size - 10

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 10 Month 01 Day Date of IRB - 2025 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067543

Disclaimer: Curated by HT Syndication.