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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus
• Interventions: Procedure: telecare consultation; Procedure: Usual face to face consultation

• Registration Number: NCT05183685
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-10
• Study Start: 2022-12-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	telecare consultation	The participants will receive alternative telecare consultation and face to face consultation every 14 weeks.
Control group	Usual face to face consultation	The participants will receive usual face to face consultation every 14 weeks.

Primary Outcome Measures

Name	Time	Method
HbA1c, defined as the amount of blood sugar attached to hemoglobin.	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.

Secondary Outcome Measures

Name	Time	Method
Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level	baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)	Investigators are measuring the change of high- and low-density lipoprotein, cholesterol level, triglyceride level
body mass index, defined as the weight in kilograms divided by height in meters.	baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)	the change of weight in kilograms divided by height in meters
Medication adherence	baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)	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.
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.	baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)	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.
Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic	baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)	To measure the utilization of healthcare services by stroke patient before and after the intervention.

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇭🇰 Tuen Mun, Hong Kong