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NCT04348565
Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting
NA trial testing Diabetes Care Programme in Diabetes Mellitus, Type 2 in 152 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 152 |
| Start date | 1 November 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Diabetes Care Programme
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04348565
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04348565 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 16 April 2020
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