Just-In-Time Adaptive Interventions for Diabetic Patients

Not Applicable

Not yet recruiting

• Conditions: Diabetes; Telemedicine; Self-Control
• Interventions: Behavioral: Active control; Behavioral: Just-in-time intervention

• Registration Number: NCT06466837
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. However, the service is time and resource-intensive. With the support of advanced technology, mhealth App seems to be a convenient way to support patients in managing diabetes.

Detailed Description

This study examines the effectiveness of mhealth App plus nurse consultations in promoting self-management behaviours for diabetic patients.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Study Start: 2024-09-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• With a confirmed DM diagnosis for one year or more than one year
• Using governmental mhealth App
• Living in an area with Internet coverage

Exclusion Criteria

• Already engaged in other mHealth programmes
• Physical and cognitive limitations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control	Active control	They will receive 6 bi-weekly nursing consultations.
Just-in-time Intervention	Just-in-time intervention	They will receive just-in-time intervention and 3 monthly nursing consultations.

Primary Outcome Measures

Name	Time	Method
Diabetic self-management behaviour	baseline, three-month, and six-month	measured using the Summary of Diabetes Self-care. Total scores range from 0 to 42, with higher scores representing better self-management performance. Activities questionnaire
Change in HbA1c	baseline, three-month, and six-month	Measured using the A1C Now device, with blood drawn from the subjects' finger

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	baseline, three-month, and six-month	By using the Chinese version of the 12-item Short Form Health Survey. Total score ranges from 0 to 100, higher the better.; version 2
Cost	three-month, and six-month	The cost of the app, including development of new features and maintenance costs, will be estimated from the provider and societal perspectives, including the subjects' travelling costs and time. An ingredient approach will be adopted to estimate the cost.
satisfaction with the JITAIs, as well as usability and technical problems	three-month	using semi-structured group interviews with the intervention group participants
Change in medication adherence	baseline, three-month, and six-month	Measure this by using the Adherence to Refills and Medications Scale. Scores from 12 to 48, higher score better medication adherence.
Change in health service utilization	baseline, three-month, and six-month	Measure the total number of unscheduled visits to general out-patient departments, general practitioners, emergency departments, and hospitals, and the total frequency of health service attendance