Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05183685
Enrollment
780
Registered
2022-01-10
Start date
2022-12-10
Completion date
2025-09-09
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus, telecare consultation

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.

Interventions

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

PROCEDUREUsual face to face consultation

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

Sponsors

Tuen Mun Hospital
CollaboratorOTHER_GOV
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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
Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride levelbaseline 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
Medication adherencebaseline 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 clinicbaseline 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

MeasureTime frameDescription
Implementation. It measures the fidelity of the programbaseline 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
Maintenance. It measures the sustained effect of the program. Cost-effectiveness will be measured by calculating the cost used in both groups.84 weeks (T3)Cost evaluation.
Adoption, which means adoption by the staff and setting. It measures the user readiness for the program adoptionbaseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)Use Readiness for Implementation Model Survey to evaluate the adoption success of telecare consultation.
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)the number of patients who are eligible to receive telecare consultation, excluded, invited to participate, and enrolled in the study

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026