Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting
NCT ID: NCT04348565
Last Updated: 2020-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
152 participants
INTERVENTIONAL
2019-11-01
2021-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Diabetes Care Programme
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
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
Standard Usual Care
People with Type 2 Diabetes Mellitus of private general practitioner (GP) with solo-practice who only receive the usual medical care at the GP
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Age 18-75
3. Haemoglobin A1c (HbA1c) \>7.0%
4. Can communicate in Cantonese
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Association of Hong Kong Nursing Staff
UNKNOWN
Chinese University of Hong Kong
OTHER
Responsible Party
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Hau Yee CHUNG
Principal Investigator
Principal Investigators
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Hau Yee H CHUNG
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Clinics of private general practitioners
Hong Kong, Hong Kong SAR, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Clinical Research Ethics
Identifier Type: OTHER
Identifier Source: secondary_id
CREC2019.290
Identifier Type: -
Identifier Source: org_study_id
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