跳至主要内容
临床试验/NCT06513468
NCT06513468尚未招募不适用

The Value of Adding Group Education (DESMOND Method) to the Standard Primary Care Education Practices in Changing Glycemic Control and Self-care Practices in Adults With Type II Diabetes Mellitus: A Randomized Controlled Intervention Study.

Primary Health Care Corporation, Qatar2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
2
主要终点
Blood HbA1C %

研究概览

简要总结

The goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the DESMOND program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . The main questions it aims to answer is:

Does adding group education (DESMOND method) to the standard primary care education practices is effective in changing glycemic control and self-care practices in adults with Type II Diabetes Mellitus .

The enrolled study participants will be randomized to receive either the standard personal health care or group health education (DESMOND) session. questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.

详细描述

  1. Objectives: This pilot, single primary healthcare center study is designed to assess the effect of delivering the group health education DESMOND program as an add-on to the standard health education in type 2 diabetic patients.
  2. Design: This is an analytic randomized controlled intervention study for adult patients who are newly diagnosed type II Diabetes Mellitus. The enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (DESMOND) session. A standard questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of HbA1C. These measurements will be repeated after 3 and 6 months of the intervention for both study groups.
  3. Setting :The Family Medicine clinics in Airport Health Center in Primary care, Qatar.
  4. Participants: Newly diagnosed type II Diabetes Mellitus aged more than 18 years.
  5. Intervention: A six-hour structured group education program to be delivered by one certified DESMOND health educator compared with the standard care.
  6. Main outcome measures : Blood HbA1C % at baseline (before starting the diabetes management protocol of PHCC), after 3, and 6 months of follow up. In addition, the Diabetes self-management score (DSMQ) after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult more than 18 years, newly diagnosed Type II diabetes mellitus (within 4 - 6 weeks of diagnosis) attending the Airport Health Care Center.
  • Not yet receiving any form of standard health education in PHCC.

排除标准

  • Using diuretics or cancer therapy.
  • Had enduring mental health problem.
  • Participants in another research study.
  • Inability to communicate in Arabic or English language

结局指标

主要结局

Blood HbA1C %

时间窗: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

The Diabetes self-management score using the (DSMQ)

时间窗: before starting the diabetes standard care , after 3, and 6 months of follow up for both arms

The Diabetes self-management score (DSMQ) at baseline , after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (DESMOND) method

次要结局

未报告次要终点

研究者

发起方
Primary Health Care Corporation, Qatar
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Engy Salah Mohamed Abdelhamed

Consultant Family Medicine

Primary Health Care Corporation, Qatar

研究点 (2)

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