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

NCT04348565 | Unknown DMC

• 2 other identifiers: CREC2019.290Clinical Research Ethics
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Care Programme; Diabetes Conversation Map; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• Glycated haemoglobin (HbA1c)

  Glycemic control

  Change from Baseline HbA1c at week 20

• 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

• 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 Outcomes (6)

• Diabetes Empowerment Scale

  Change from Baseline Psycho-social Self-efficacy level at week 8

• Diabetes Empowerment Scale

  Change from Baseline Psycho-social Self-efficacy level at week 20

• Diabetes Knowledge Questionnaire

  Change from Baseline Diabetes self-care knowledge at week 8

• Diabetes Knowledge Questionnaire

  Change from Baseline Diabetes self-care knowledge at week 20

• Quality of life Measurement

  Change from Baseline Quality of Life status at week 8

Study Arms (2)

Diabetes Care Programme

EXPERIMENTAL

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

Other: Diabetes Care Programme

Standard Usual Care

NO INTERVENTION

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

Interventions

Diabetes Care Programme OTHER

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

Diabetes Care Programme

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with T2DM and follow up at private general practitioner
• Age 18-75
• Haemoglobin A1c (HbA1c) \>7.0%
• Can communicate in Cantonese

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Association of Hong Kong Nursing Staff: collaborator

Study Sites (1)

Clinics of private general practitioners

Hong Kong, Hong Kong SAR, Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hau Yee H CHUNG

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hau Yee H CHUNG

CONTACT

+852-9651-5919; harrietchung@link.cuhk.edu.hk

Wai Tong CHIEN, Professor

CONTACT

+852-3943-8172; wtchien@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: single-blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 16, 2020
• Study Start: November 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: April 16, 2020

Record last verified: 2020-04

Locations

HK (1)