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Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Diabetes Care Programme
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Care Programme, Diabetes Conversation Map, Type 2 diabetes mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. People with T2DM and follow up at private general practitioner
  2. Age 18-75
  3. Haemoglobin A1c (HbA1c) >7.0%
  4. Can communicate in Cantonese

Exclusion Criteria:

  1. Insulin users
  2. Unstable emotional and/or mental status
  3. Cognitive impairment and/or learning disabilities
  4. Recruited in other research and/or diabetes educational programme during the study period

Sites / Locations

  • Clinics of private general practitionersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes Care Programme

Standard Usual Care

Arm Description

People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who receive the intervention (Diabetes Care Programme) in addition to usual medical care at the GP

People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who only receive the usual medical care at the GP

Outcomes

Primary Outcome Measures

Glycated haemoglobin (HbA1c)
Glycemic control
Self-efficacy level in diabetes management
To assess the Self-efficacy level in diabetes management of Chinese people with diabetes. Includes 20 items of self-care in six domains with 1-10 rating scale. Higher score means better self-care.
Self-efficacy level in diabetes management
To assess the Self-efficacy level in diabetes management of Chinese people with diabetes. Includes 20 items of self-care in six domains with 1-10 rating scale. Higher score means better self-care.

Secondary Outcome Measures

Diabetes Empowerment Scale
To assess the overall psycho-social self-efficacy level of Chinese people with diabetes. It includes 10 items with a 1-5 rating scale. A higher score means a higher level of self-efficacy.
Diabetes Empowerment Scale
To assess the overall psycho-social self-efficacy level of Chinese people with diabetes. It includes 10 items with a 1-5 rating scale. A higher score means a higher level of self-efficacy.
Diabetes Knowledge Questionnaire
To assess the Diabetes self-care knowledge of Chinese people with diabetes. It includes 24 items of diabetes self-care knowledge with the total score range from 0-24. Valid responses with "yes", "no" or "I don't know"; only scored on correct answers. A higher score means a higher level of diabetes knowledge.
Diabetes Knowledge Questionnaire
To assess the Diabetes self-care knowledge of Chinese people with diabetes. It includes 24 items of diabetes self-care knowledge with the total score range from 0-24. Valid responses with "yes", "no" or "I don't know"; only scored on correct answers. A higher score means a higher level of diabetes knowledge.
Quality of life Measurement
The valuation of health status (quality of life) of Chinese people. It includes 5 health dimensions with a sum of negative validity & 1 visual analog scale to reflect the self-rated health score. A higher score means a higher quality of life status.
Quality of life Measurement
The valuation of health status (quality of life) of Chinese people. It includes 5 health dimensions with a sum of negative validity & 1 visual analog scale to reflect the self-rated health score. A higher score means a higher quality of life status.

Full Information

First Posted
April 5, 2020
Last Updated
April 13, 2020
Sponsor
Chinese University of Hong Kong
Collaborators
Association of Hong Kong Nursing Staff
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1. Study Identification

Unique Protocol Identification Number
NCT04348565
Brief Title
Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting
Official Title
An Evaluation of the Effect of a Diabetes Care Programme for People With Type 2 Diabetes Mellitus in Primary Care Setting: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Association of Hong Kong Nursing Staff

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Uncontrolled metabolic parameters and co-morbidity risk factors cause Diabetes Mellitus as the leading cause of a multitude of micro-/macro-vascular complications. According to the International Guidelines and Recommendations, people with Type 2 Diabetes Mellitus (T2DM) should attend diabetes educational programmes periodically and optimize the metabolic index of control. In Hong Kong, General Practitioners with solo-practice (GP-SP) have the least availability of resources and support in DM management. A discrepancy of diabetes care between public and private settings and a gap of clinical practice between public-private healthcare settings is identified. In relation to the big population of T2DM is caring by GP-SP but no structured Diabetes Care Programme (DCP) is in place. A structured DCP for T2DM is in need to fill up the clinical gap and make beneficial to the target subjects. The aim of this study is to evaluate the effectiveness of a DCP for people with T2DM in primary care settings. It is a multi-center, single-blind randomized controlled trial with parallel groups pre-test and post-test design. The evidence-based intervention (DCP) will be carried out in a private primary care setting. People with T2DM attending the GP-SP who meet the study criteria will be randomly assigned into one of the two study groups, either "DCP in addition to usual medical care" or "Usual medical care only" as a control group. The intervention group can beneficial in clinical and psychosocial outcomes after the completion of the 20-week structured DCP with a greater improvement of HbA1c level, Self-Efficacy in diabetes management, Diabetes Empowerment level, Diabetes Knowledge, and Quality of Life than those who only received usual medical care at the GP-SP.
Detailed Description
This study is to implement an evidence-based develop Diabetes Care Programme (DCP) for 152 adults with Type 2 Diabetes Mellitus (T2DM) in a few clinics of a general practitioner with solo-practice (GP-SP) in community, and evaluate its effectiveness by comparing the outcomes between study group (DCP with the usual medical care) and control group (Usual medical care only). It is believed that a structured DCP can promote greater clinical outcomes improvement and behavioral changes in the study group as evidence showed in literature. The primary outcomes are glycemic control (HbA1c level) and Self-Efficacy in diabetes management; whereas Diabetes Empowerment level, Diabetes Knowledge and Quality of Life are the secondary outcomes. The DCP consists of two parts, conduct 3 interactive group education with an innovative educational tool "Diabetes Conversation Map™" sessions by dietitian and diabetes educator/nurse. Then it followed by another 8 weeks for delivering two 15-30 minutes teleconsultations for patient empowerment and follow-up of "Action Plan" by a diabetes educator/nurse. Evaluation of outcomes will be done before the DCP (baseline), at week-8 (right after the group sessions), and at week-20 (4 weeks after the last teleconsultation). In addition, a focus group interview will be carried out after the completion of the whole intervention. It purposes to explore and get valuable descriptive information and feelings from participants about the intervention and diabetes self-management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Care Programme, Diabetes Conversation Map, Type 2 diabetes mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Care Provider
Masking Description
single-blind
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Care Programme
Arm Type
Experimental
Arm Description
People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who receive the intervention (Diabetes Care Programme) in addition to usual medical care at the GP
Arm Title
Standard Usual Care
Arm Type
No Intervention
Arm Description
People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who only receive the usual medical care at the GP
Intervention Type
Other
Intervention Name(s)
Diabetes Care Programme
Intervention Description
20-week Diabetes Care Programme consists of three Diabetes Conversation Map sessions in 8 weeks with 3-4 weeks intervals, then two teleconsultations at week 12th and week 16th
Primary Outcome Measure Information:
Title
Glycated haemoglobin (HbA1c)
Description
Glycemic control
Time Frame
Change from Baseline HbA1c at week 20
Title
Self-efficacy level in diabetes management
Description
To assess the Self-efficacy level in diabetes management of Chinese people with diabetes. Includes 20 items of self-care in six domains with 1-10 rating scale. Higher score means better self-care.
Time Frame
Change from Baseline Self-efficacy level at week 8
Title
Self-efficacy level in diabetes management
Description
To assess the Self-efficacy level in diabetes management of Chinese people with diabetes. Includes 20 items of self-care in six domains with 1-10 rating scale. Higher score means better self-care.
Time Frame
Change from Baseline Self-efficacy level at week 20
Secondary Outcome Measure Information:
Title
Diabetes Empowerment Scale
Description
To assess the overall psycho-social self-efficacy level of Chinese people with diabetes. It includes 10 items with a 1-5 rating scale. A higher score means a higher level of self-efficacy.
Time Frame
Change from Baseline Psycho-social Self-efficacy level at week 8
Title
Diabetes Empowerment Scale
Description
To assess the overall psycho-social self-efficacy level of Chinese people with diabetes. It includes 10 items with a 1-5 rating scale. A higher score means a higher level of self-efficacy.
Time Frame
Change from Baseline Psycho-social Self-efficacy level at week 20
Title
Diabetes Knowledge Questionnaire
Description
To assess the Diabetes self-care knowledge of Chinese people with diabetes. It includes 24 items of diabetes self-care knowledge with the total score range from 0-24. Valid responses with "yes", "no" or "I don't know"; only scored on correct answers. A higher score means a higher level of diabetes knowledge.
Time Frame
Change from Baseline Diabetes self-care knowledge at week 8
Title
Diabetes Knowledge Questionnaire
Description
To assess the Diabetes self-care knowledge of Chinese people with diabetes. It includes 24 items of diabetes self-care knowledge with the total score range from 0-24. Valid responses with "yes", "no" or "I don't know"; only scored on correct answers. A higher score means a higher level of diabetes knowledge.
Time Frame
Change from Baseline Diabetes self-care knowledge at week 20
Title
Quality of life Measurement
Description
The valuation of health status (quality of life) of Chinese people. It includes 5 health dimensions with a sum of negative validity & 1 visual analog scale to reflect the self-rated health score. A higher score means a higher quality of life status.
Time Frame
Change from Baseline Quality of Life status at week 8
Title
Quality of life Measurement
Description
The valuation of health status (quality of life) of Chinese people. It includes 5 health dimensions with a sum of negative validity & 1 visual analog scale to reflect the self-rated health score. A higher score means a higher quality of life status.
Time Frame
Change from Baseline Quality of Life status at week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People with T2DM and follow up at private general practitioner Age 18-75 Haemoglobin A1c (HbA1c) >7.0% Can communicate in Cantonese Exclusion Criteria: Insulin users Unstable emotional and/or mental status Cognitive impairment and/or learning disabilities Recruited in other research and/or diabetes educational programme during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hau Yee H CHUNG
Phone
+852-9651-5919
Email
harrietchung@link.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Tong CHIEN, Professor
Phone
+852-3943-8172
Email
wtchien@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hau Yee H CHUNG
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics of private general practitioners
City
Hong Kong
State/Province
Hong Kong SAR
ZIP/Postal Code
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwok Wai A CHEUNG, Dr.
Phone
+852-9844-4955
Email
alvinckw2000@yahoo.com

12. IPD Sharing Statement

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Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting

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