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Completed

NCT Number: NCT05183685

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuen Mun Hospital

Tuenmen, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telecare consultation

Procedure

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

Usual face to face consultation

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Tuen Mun Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2022
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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