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
- Are there results?
- None posted in the registry
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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06466837
- Acronym / sponsor ID
- AWong
- Conditions
- Diabetes, Self-Control, Telemedicine
- Keywords
- telecare, older adults, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blinded, two-armed, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Just-in-time Intervention | Experimental | Behavioral: Just-in-time interventionThey will receive just-in-time intervention and 3 monthly nursing consultations. |
| Active Control | Active comparator | Behavioral: Active controlThey will receive 6 bi-weekly nursing consultations. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With a confirmed DM diagnosis for one year or more than one year
- Using governmental mhealth App
- Living in an area with Internet coverage
Key exclusion criteria (2 listed)
- Already engaged in other mHealth programmes
- Physical and cognitive limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Just-in-time interventionThe intervention group participants will receive just-in-time intervention from a developed app for healthy behavior reminder | Behavioural | Just-in-time Intervention |
| Active controlThe control group participants will receive six nursing consultations during the 3-month program period. | Behavioural | Active Control |
Primary outcome
Change in HbA1c
Time frame: baseline, three-month, and six-month
Measured using the A1C Now device, with blood drawn from the subjects' finger
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
5 secondary outcomes
Change in quality of life
Time frame: baseline, three-month, and six-month
Change in medication adherence
Time frame: baseline, three-month, and six-month
Change in health service utilization
Time frame: baseline, three-month, and six-month
Cost
Time frame: three-month, and six-month
satisfaction with the JITAIs, as well as usability and technical problems
Time frame: three-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arkers Wong, PhD principal investigator
The Hong Kong Polytechnic University
Arkers NR Wong principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: baseline, three-month, and six-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.