Just-In-Time Adaptive Interventions for Diabetic Patients

Diabetes Clinical Trial

Official title:

Promoting Self-management Behaviours Among Older Adults With Diabetes Mellitus by Integrating Just-In-Time Adaptive Interventions in Mobile Health Applications: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466837
• Other study ID #: AWong
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2024
• Source: The Hong Kong Polytechnic University
• Contact: Arkers Wong, PhD
• Phone: 852 3400 3805
• Email: arkers.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: March 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Self-Control
• Telemedicine

Intervention

Behavioral:
• Just-in-time intervention
The intervention group participants will receive just-in-time intervention from a developed app for healthy behavior reminder
• Active control
The control group participants will receive six nursing consultations during the 3-month program period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Measured using the A1C Now device, with blood drawn from the subjects' finger	baseline, three-month, and six-month
Primary	Diabetic self-management behaviour	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	baseline, three-month, and six-month
Secondary	Change in quality of life	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	baseline, three-month, and six-month
Secondary	Change in medication adherence	Measure this by using the Adherence to Refills and Medications Scale. Scores from 12 to 48, higher score better medication adherence.	baseline, three-month, and six-month
Secondary	Change in health service utilization	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	baseline, three-month, and six-month
Secondary	Cost	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.	three-month, and six-month
Secondary	satisfaction with the JITAIs, as well as usability and technical problems	using semi-structured group interviews with the intervention group participants	three-month