a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Procedure: telecare consultation
* Procedure: Usual face to face consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic Exclusion Criteria: having dementia, having unaccompanied hearing or vision loss, not having an Internet connection at home

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The participants will receive alternative telecare consultation and face to face consultation every 14 weeks. | Procedure: telecare consultation<br>* Participants will use zoom to communicate with the doctors in clinic.<br>|
| Placebo Comparator: Control group<br>The participants will receive usual face to face consultation every 14 weeks. | Procedure: Usual face to face consultation<br>* Participants will have face-to-face communication with the doctors in clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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. | baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, telecare consultation