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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183685
• Other study ID #: A0034230
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: The Hong Kong Polytechnic University
• Contact: Arkers Wong, Ph.D.
• Phone: 85234003805
• Email: arkers.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Procedure:
• telecare consultation
Participants will use zoom to communicate with the doctors in clinic.
• Usual face to face consultation
Participants will have face-to-face communication with the doctors in clinic.

Locations

Country	Name	City	State
Hong Kong	Tuen Mun Hospital	Tuen Mun

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Tuen Mun Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach, which means reach into the target population. It measures the number of patients who are eligible to receive telecare consultation, excluded, invited.	the number of patients who are eligible to receive telecare consultation, excluded, invited to participate, and enrolled in the study	84 weeks (T3)
Other	Adoption, which means adoption by the staff and setting. It measures the user readiness for the program adoption	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)
Other	Implementation. It measures the fidelity of the program	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)
Other	Maintenance. It measures the sustained effect of the program. Cost-effectiveness will be measured by calculating the cost used in both groups.	Cost evaluation.	84 weeks (T3)
Primary	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	Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level	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)
Secondary	body mass index, defined as the weight in kilograms divided by height in meters.	the change of weight in kilograms divided by height in meters	baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Secondary	Medication adherence	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)
Secondary	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.	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)
Secondary	Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic	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)