Clinical trial NCT05183685: a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
telecare consultation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tuen Mun Hospital
First posted: 2022-01-10
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c, defined as the amount of blood sugar attached to hemoglobin.
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Secondary outcomes:
measure: Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
measure: body mass index, defined as the weight in kilograms divided by height in meters.
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
measure: Medication adherence
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
measure: 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.
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
measure: Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Other outcomes:
measure: Reach, which means reach into the target population. It measures the number of patients who are eligible to receive telecare consultation, excluded, invited.
timeFrame: 84 weeks (T3)
measure: Adoption, which means adoption by the staff and setting. It measures the user readiness for the program adoption
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
measure: Implementation. It measures the fidelity of the program
timeFrame: baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
measure: Maintenance. It measures the sustained effect of the program. Cost-effectiveness will be measured by calculating the cost used in both groups.
timeFrame: 84 weeks (T3)
Locations:
city: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital
Study officials:
References: