Diabetes MellitusNCT05183685
a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus
A study testing telecare consultation and Usual face to face consultation in people with Diabetes Mellitus, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Telecare consultation, which is defined as a two-way synchronized visual (voice and image) communication between patients and healthcare professionals using telecommunication applications such as Zoom, has become a major trend in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- telecare consultation and Usual face to face consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Dec 2022to 9 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic
Who cannot join
- having dementia, having unaccompanied hearing or vision loss, not having an Internet connection at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus in General Out-patient Clinic: A Hybrid Effectiveness-implementation Study
Telecare consultation, which is defined as a two-way synchronized visual (voice and image) communication between patients and healthcare professionals using telecommunication applications such as Zoom, has become a major trend in recent years. The current COVID-19 pandemic provides an impetus to drive change and increase the uptake of telecare consultation in healthcare. To the best of investigators' knowledge, there is no translational research available that simultaneously implements and evaluates the telecare model of care delivered in a primary care setting. The present study will be the first in Hong Kong to fill this service and knowledge gap in the care of DM patients.
- Conditions
- Diabetes Mellitus
- Being tested
- telecare consultation, Usual face to face consultation
- Keywords
- diabetes mellitus, telecare consultation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telecare consultationProcedure or surgery
Participants will use zoom to communicate with the doctors in clinic.
Usual face to face consultationProcedure or surgery
Participants will have face-to-face communication with the doctors in clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants will receive alternative telecare consultation and face to face consultation every 14 weeks. Receives: Procedure: telecare consultation |
| Control group | Placebo comparator | The participants will receive usual face to face consultation every 14 weeks. Receives: Procedure: Usual face to face consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, defined as the amount of blood sugar attached to hemoglobin.
An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months. It's a three-month average because that's typically how long a red blood cell lives. The blood glucose level will be measured at baseline pre-intervention, 42 weeks, and 84 weeks by a doctor.
Measured: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Secondary outcomes (5)
Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level
Investigators are measuring the change of high- and low-density lipoprotein, cholesterol level, triglyceride level
Measured: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
body mass index, defined as the weight in kilograms divided by height in meters.
the change of weight in kilograms divided by height in meters
Measured: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Medication adherence
the change of Medication adherence will be determined using the Adherence to Refills and Medications Scale. This 12-item scale has a total score ranged from 12 to 48, with lower scores representing better medication adherence.
Measured: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Quality of life, defined by the standard of health, comfort, experienced by diabetic patients, which is measured by SF-12 questionnaire. SF-12 questionnaire can measure the physical and mental health components of quality of life among diabetic patients.
Investigators will measure the change of physical and mental health components of quality of life of participants, measured by the Chinese version of Short-form 12-item version 2 scale.The 12 items in the questionnaire included two from each of the physical functioning (PF), role limitation due to physical problems (RP), role limitation due to emotional problems (RE), and mental health (MH) scale and one item from each of the bodily pain (BP), general health (GH), vitality (VT), and social functioning (SF) scale of the original SF-36 questionnaires. The items in the questionnaire were rated on Likert-type scales and summed to provide easily interpretable scales for physical and mental health components. Higher scores indicated better quality of life.
Measured: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic
To measure the utilization of healthcare services by stroke patient before and after the intervention.
Measured: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start10 Dec 2022
- Primary completion31 Aug 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tuen Mun Hospital
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183685
- Sponsor's protocol ID
- A0034230
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong AKC, Liu LZ, Wong FKY, Liang J, Tong DWK, Chan ML, Wong MK, Wong BC, Tang YS, Ho WH, Chiang SC. Who chooses telehealth? A cross-sectional cohort study of diabetic patients in outpatient clinic follow-up. PLOS Digit Health. 2026 Jul 9;5(7):e0001545. doi: 10.1371/journal.pdig.0001545. eCollection 2026 Jul.
PubMed 42424348Wong AKC, Liu LZ, Wong FKY, Liang J, Tong DWK, Chan ML, Wong MK, Wong BC, Tang CYS, Ho WH, Chiang SC. Voices from the field: healthcare professionals' insights on sustaining telemedicine for diabetes management in Hong Kong primary care. Front Digit Health. 2025 Nov 28;7:1665424. doi: 10.3389/fdgth.2025.1665424. eCollection 2025.
PubMed 41395628
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus in General Out-patient Clinic: A Hybrid Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT05183685
- Acronym / sponsor ID
- A0034230
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, telecare consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tuen Mun Hospital
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 10 Jan 2022 (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.
Telecare consultation, which is defined as a two-way synchronized visual (voice and image) communication between patients and healthcare professionals using telecommunication applications such as Zoom, has become a major trend in recent years. The current COVID-19 pandemic provides an impetus to drive change and increase the uptake of telecare consultation in healthcare. To the best of investigators' knowledge, there is no translational research available that simultaneously implements and evaluates the telecare model of care delivered in a primary care setting. The present study will be the first in Hong Kong to fill this service and knowledge gap in the care of DM patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: telecare consultationThe participants will receive alternative telecare consultation and face to face consultation every 14 weeks. |
| Control group | Placebo comparator | Procedure: Usual face to face consultationThe participants will receive usual face to face consultation every 14 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic
Key exclusion criteria (1 listed)
- having dementia, having unaccompanied hearing or vision loss, not having an Internet connection at home
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 |
|---|---|---|
| telecare consultationParticipants will use zoom to communicate with the doctors in clinic. | Procedure or surgery | Intervention group |
| Usual face to face consultationParticipants will have face-to-face communication with the doctors in clinic. | Procedure or surgery | Control group |
Primary outcome
HbA1c, defined as the amount of blood sugar attached to hemoglobin.
Time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months. It's a three-month average because that's typically how long a red blood cell lives. The blood glucose level will be measured at baseline pre-intervention, 42 weeks, and 84 weeks by a doctor.
5 secondary outcomes
Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level
Time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
body mass index, defined as the weight in kilograms divided by height in meters.
Time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Medication adherence
Time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Quality of life, defined by the standard of health, comfort, experienced by diabetic patients, which is measured by SF-12 questionnaire. SF-12 questionnaire can measure the physical and mental health components of quality of life among diabetic patients.
Time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic
Time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
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 15 Sep 2025.
- Derived from this study: PubMed 42424348Wong AKC, Liu LZ, Wong FKY, Liang J, Tong DWK, Chan ML, Wong MK, Wong BC, Tang YS, Ho WH, Chiang SC. Who chooses telehealth? A cross-sectional cohort study of diabetic patients in outpatient clinic follow-up. PLOS Digit Health. 2026 Jul 9;5(7):e0001545. doi: 10.1371/journal.pdig.0001545. eCollection 2026 Jul.
- Derived from this study: PubMed 41395628Wong AKC, Liu LZ, Wong FKY, Liang J, Tong DWK, Chan ML, Wong MK, Wong BC, Tang CYS, Ho WH, Chiang SC. Voices from the field: healthcare professionals' insights on sustaining telemedicine for diabetes management in Hong Kong primary care. Front Digit Health. 2025 Nov 28;7:1665424. doi: 10.3389/fdgth.2025.1665424. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telecare consultation and Usual face to face consultation in people with Diabetes Mellitus, 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 1 inclusion and 1 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 15 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
HbA1c, defined as the amount of blood sugar attached to hemoglobin. (time frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183685, which also lists 2 linked publications.
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 15 Sep 2025.