DiabetesNCT06466837
Just-In-Time Adaptive Interventions for Diabetic Patients
A study testing Just-in-time intervention in people with Diabetes and Self-Control, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes, Self-Control, Telemedicine
- What is being tested?
- Just-in-time intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 31 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a confirmed DM diagnosis for one year or more than one year
- Using governmental mhealth App
- Living in an area with Internet coverage
Who cannot join
- Already engaged in other mHealth programmes
- Physical and cognitive limitations
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This study examines the effectiveness of mhealth App plus nurse consultations in promoting self-management behaviours for diabetic patients.
- Conditions
- Diabetes, Self-Control, Telemedicine
- Being tested
- Just-in-time intervention, Active control
- Keywords
- telecare, older adults, diabetes
- Medical subject headings
- Diabetes Mellitus, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-in-time interventionBehavioural
The intervention group participants will receive just-in-time intervention from a developed app for healthy behavior reminder
Active controlBehavioural
The control group participants will receive six nursing consultations during the 3-month program period.
| Study group | Role | What they receive |
|---|---|---|
| Just-in-time Intervention | Experimental | They will receive just-in-time intervention and 3 monthly nursing consultations. Receives: Behavioral: Just-in-time intervention |
| Active Control | Active comparator | They will receive 6 bi-weekly nursing consultations. Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured using the A1C Now device, with blood drawn from the subjects' finger
Measured: baseline, three-month, and six-month
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
Measured: baseline, three-month, and six-month
Secondary outcomes (5)
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
Measured: baseline, three-month, and six-month
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.
Measured: baseline, three-month, and six-month
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
Measured: baseline, three-month, and six-month
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.
Measured: three-month, and six-month
satisfaction with the JITAIs, as well as usability and technical problems
using semi-structured group interviews with the intervention group participants
Measured: three-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Sep 2024
- Primary completion1 May 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded, two-armed, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
- Investigators
- Arkers Wong, PhD, Principal investigator, The Hong Kong Polytechnic UniversityArkers NR Wong, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466837
- Sponsor's protocol ID
- AWong
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No