Back to resultsa Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus
Primary Purpose
Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
telecare consultation
Usual face to face consultation
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus focused on measuring diabetes mellitus, telecare consultation
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
Sites / Locations
- Tuen Mun HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
The participants will receive alternative telecare consultation and face to face consultation every 14 weeks.
The participants will receive usual face to face consultation every 14 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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.
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.
Full Information
NCT ID
NCT05183685
First Posted
December 7, 2021
Last Updated
March 2, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
Tuen Mun Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05183685
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Tuen Mun Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
diabetes mellitus, telecare consultation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The participants will receive alternative telecare consultation and face to face consultation every 14 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The participants will receive usual face to face consultation every 14 weeks.
Intervention Type
Procedure
Intervention Name(s)
telecare consultation
Intervention Description
Participants will use zoom to communicate with the doctors in clinic.
Intervention Type
Procedure
Intervention Name(s)
Usual face to face consultation
Intervention Description
Participants will have face-to-face communication with the doctors in clinic.
Primary Outcome Measure Information:
Title
HbA1c, defined as the amount of blood sugar attached to hemoglobin.
Description
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.
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Secondary Outcome Measure Information:
Title
Fasting lipid profile that will be drawn by patient's blood. The profile includes high and low-density lipoprotein, cholesterol level, and triglyceride level
Description
Investigators are measuring the change of high- and low-density lipoprotein, cholesterol level, triglyceride level
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Title
body mass index, defined as the weight in kilograms divided by height in meters.
Description
the change of weight in kilograms divided by height in meters
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Title
Medication adherence
Description
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.
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Title
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.
Description
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.
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Title
Number of attendances at a general practitioners' office, emergency department, hospital, and general out-patient clinic
Description
To measure the utilization of healthcare services by stroke patient before and after the intervention.
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Other Pre-specified Outcome Measures:
Title
Reach, which means reach into the target population. It measures the number of patients who are eligible to receive telecare consultation, excluded, invited.
Description
the number of patients who are eligible to receive telecare consultation, excluded, invited to participate, and enrolled in the study
Time Frame
84 weeks (T3)
Title
Adoption, which means adoption by the staff and setting. It measures the user readiness for the program adoption
Description
Use Readiness for Implementation Model Survey to evaluate the adoption success of telecare consultation.
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Title
Implementation. It measures the fidelity of the program
Description
Use performance checklist to evaluate whether each task of the intervention has been implemented according to the protocol
Time Frame
baseline pre-intervention (T1), 42 weeks (T2) and 84 weeks (T3)
Title
Maintenance. It measures the sustained effect of the program. Cost-effectiveness will be measured by calculating the cost used in both groups.
Description
Cost evaluation.
Time Frame
84 weeks (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arkers Wong, Ph.D.
Phone
85234003805
Email
arkers.wong@polyu.edu.hk
Facility Information:
Facility Name
Tuen Mun Hospital
City
Tuen Mun
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Chu Wong
Phone
85224686779
12. IPD Sharing Statement
Plan to Share IPD
No
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a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus
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