Clinical trial NCT04348565: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Care Programme
Diabetes Conversation Map
Type 2 diabetes mellitus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Association of Hong Kong Nursing Staff
First posted: 2020-04-16
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: Change from Baseline HbA1c at week 20
measure: Self-efficacy level in diabetes management
timeFrame: Change from Baseline Self-efficacy level at week 8
measure: Self-efficacy level in diabetes management
timeFrame: Change from Baseline Self-efficacy level at week 20
Secondary outcomes:
measure: Diabetes Empowerment Scale
timeFrame: Change from Baseline Psycho-social Self-efficacy level at week 8
measure: Diabetes Empowerment Scale
timeFrame: Change from Baseline Psycho-social Self-efficacy level at week 20
measure: Diabetes Knowledge Questionnaire
timeFrame: Change from Baseline Diabetes self-care knowledge at week 8
measure: Diabetes Knowledge Questionnaire
timeFrame: Change from Baseline Diabetes self-care knowledge at week 20
measure: Quality of life Measurement
timeFrame: Change from Baseline Quality of Life status at week 8
measure: Quality of life Measurement
timeFrame: Change from Baseline Quality of Life status at week 20
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Clinics of private general practitioners
state: Hong Kong SAR
Study officials:
affiliation: Chinese University of Hong Kong
name: Hau Yee H CHUNG
role: PRINCIPAL_INVESTIGATOR
References: