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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04348565
• Other study ID #: CREC2019.290
• Secondary ID: Clinical Researc
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2020
• Source: Chinese University of Hong Kong
• Contact: Hau Yee H CHUNG
• Phone: +852-9651-5919
• Email: harrietchung[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Diabetes Care Programme
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

Locations

Country	Name	City	State
Hong Kong	Clinics of private general practitioners	Hong Kong	Hong Kong SAR

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Association of Hong Kong Nursing Staff

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated haemoglobin (HbA1c)	Glycemic control	Change from Baseline HbA1c at week 20
Primary	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.	Change from Baseline Self-efficacy level at week 8
Primary	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.	Change from Baseline Self-efficacy level at week 20
Secondary	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.	Change from Baseline Psycho-social Self-efficacy level at week 8
Secondary	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.	Change from Baseline Psycho-social Self-efficacy level at week 20
Secondary	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.	Change from Baseline Diabetes self-care knowledge at week 8
Secondary	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.	Change from Baseline Diabetes self-care knowledge at week 20
Secondary	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.	Change from Baseline Quality of Life status at week 8
Secondary	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.	Change from Baseline Quality of Life status at week 20