- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466837
Just-In-Time Adaptive Interventions for Diabetic Patients
September 8, 2025 updated by: Arkers, Wong, The Hong Kong Polytechnic University
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study examines the effectiveness of mhealth App plus nurse consultations in promoting self-management behaviours for diabetic patients.
Study Type
Interventional
Enrollment (Estimated)
184
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arkers Wong, PhD
- Phone Number: 852 3400 3805
- Email: arkers.wong@polyu.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- District Health Center
-
Contact:
- Stella Au, MSc
- Phone Number: +85234003805
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Just-in-time Intervention
They will receive just-in-time intervention and 3 monthly nursing consultations.
|
The intervention group participants will receive just-in-time intervention from a developed app for healthy behavior reminder
|
|
Active Comparator: Active Control
They will receive 6 bi-weekly nursing consultations.
|
The control group participants will receive six nursing consultations during the 3-month program period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c
Time Frame: baseline, three-month, and six-month
|
Measured using the A1C Now device, with blood drawn from the subjects' finger
|
baseline, three-month, and six-month
|
|
Diabetic self-management behaviour
Time Frame: 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
|
baseline, three-month, and six-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life
Time Frame: 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 |
baseline, three-month, and six-month
|
|
Change in medication adherence
Time Frame: 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.
|
baseline, three-month, and six-month
|
|
Change in health service utilization
Time Frame: 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
|
baseline, three-month, and six-month
|
|
Cost
Time Frame: 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.
|
three-month, and six-month
|
|
satisfaction with the JITAIs, as well as usability and technical problems
Time Frame: three-month
|
using semi-structured group interviews with the intervention group participants
|
three-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arkers Wong, PhD, The Hong Kong Polytechnic University
- Principal Investigator: Arkers NR Wong, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
June 14, 2024
First Submitted That Met QC Criteria
June 14, 2024
First Posted (Actual)
June 20, 2024
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 8, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWong
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.