Diabetes Care Programme for Type 2 Diabetes Mellitus in Primary Care Setting
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
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Hong Kong SAR
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Hong Kong、Hong Kong SAR、香港、Hong Kong
- 募集
- Clinics of private general practitioners
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コンタクト：
- Kwok Wai A CHEUNG, Dr.
- 電話番号：+852-9844-4955
- メール：alvinckw2000@yahoo.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- People with T2DM and follow up at private general practitioner
- Age 18-75
- Haemoglobin A1c (HbA1c) >7.0%
- Can communicate in Cantonese
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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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
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介入なし：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Glycated haemoglobin (HbA1c)
時間枠：Change from Baseline HbA1c at week 20
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Glycemic control
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Change from Baseline HbA1c at week 20
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Self-efficacy level in diabetes management
時間枠：Change from Baseline Self-efficacy level at week 8
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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.
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Change from Baseline Self-efficacy level at week 8
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Self-efficacy level in diabetes management
時間枠：Change from Baseline Self-efficacy level at week 20
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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.
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Change from Baseline Self-efficacy level at week 20
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diabetes Empowerment Scale
時間枠：Change from Baseline Psycho-social Self-efficacy level at week 8
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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.
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Change from Baseline Psycho-social Self-efficacy level at week 8
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Diabetes Empowerment Scale
時間枠：Change from Baseline Psycho-social Self-efficacy level at week 20
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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.
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Change from Baseline Psycho-social Self-efficacy level at week 20
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Diabetes Knowledge Questionnaire
時間枠：Change from Baseline Diabetes self-care knowledge at week 8
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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.
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Change from Baseline Diabetes self-care knowledge at week 8
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Diabetes Knowledge Questionnaire
時間枠：Change from Baseline Diabetes self-care knowledge at week 20
|
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.
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Change from Baseline Diabetes self-care knowledge at week 20
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Quality of life Measurement
時間枠：Change from Baseline Quality of Life status at week 8
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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.
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Change from Baseline Quality of Life status at week 8
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Quality of life Measurement
時間枠：Change from Baseline Quality of Life status at week 20
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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.
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Change from Baseline Quality of Life status at week 20
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協力者と研究者
捜査官
- 主任研究者：Hau Yee H CHUNG、Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CREC2019.290
- Clinical Research Ethics (その他の識別子：Joint CUHK-NTEC CREC)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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