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

NCT05183685 | Completed

• 1 other identifier: A0034230
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; telecare consultation

Outcome Measures

Primary Outcomes (1)

• 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 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

  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.

  baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)

• 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.

  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

  baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)

Other Outcomes (4)

• Reach, which means reach into the target population. It measures the number of patients who are eligible to receive telecare consultation, excluded, invited.

  84 weeks (T3)

• Adoption, which means adoption by the staff and setting. It measures the user readiness for the program adoption

  baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)

• Implementation. It measures the fidelity of the program

  baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants will receive alternative telecare consultation and face to face consultation every 14 weeks.

Procedure: telecare consultation

Control group

PLACEBO COMPARATOR

The participants will receive usual face to face consultation every 14 weeks.

Procedure: Usual face to face consultation

Interventions

telecare consultation PROCEDURE

Participants will use zoom to communicate with the doctors in clinic.

Intervention group

Usual face to face consultation PROCEDURE

Participants will have face-to-face communication with the doctors in clinic.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic

You may not qualify if:

• having dementia, having unaccompanied hearing or vision loss, not having an Internet connection at home

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Tuen Mun Hospital: collaborator

Study Sites (1)

Tuen Mun Hospital

Tuenmen, Hong Kong

Location

Related Publications (1)

• Wong 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.

  PMID: 41395628 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 10, 2022
• Study Start: December 10, 2022
• Primary Completion: August 31, 2025
• Study Completion: September 9, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)