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

September 8, 2025 updated by: Arkers, Wong, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

780

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Tuenmen, Hong Kong
        • Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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
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)
the change of weight in kilograms divided by height in meters
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)
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.
Time Frame: 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.
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)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach, which means reach into the target population. It measures the number of patients who are eligible to receive telecare consultation, excluded, invited.
Time Frame: 84 weeks (T3)
the number of patients who are eligible to receive telecare consultation, excluded, invited to participate, and enrolled in the study
84 weeks (T3)
Adoption, which means adoption by the staff and setting. It measures the user readiness for the program adoption
Time Frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Use Readiness for Implementation Model Survey to evaluate the adoption success of telecare consultation.
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Implementation. It measures the fidelity of the program
Time Frame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Use performance checklist to evaluate whether each task of the intervention has been implemented according to the protocol
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Maintenance. It measures the sustained effect of the program. Cost-effectiveness will be measured by calculating the cost used in both groups.
Time Frame: 84 weeks (T3)
Cost evaluation.
84 weeks (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Tuen Mun Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2022

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

September 9, 2025

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0034230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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