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临床试验/NCT04847856
NCT04847856已完成不适用

Effectiveness of Diabetic Self-care Education at Primary Health Care Centres in Saudi Arabia: A Pragmatic Randomized Trial in Tabuk

University of Tabuk2 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2020年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
179
试验地点
2
主要终点
To compare the mean differences in the: Blood glucose level, BMI, Waist circumference between intervention and control groups

研究概览

简要总结

Diabetes Self-care Education (DSCE) is a formal term used to describe the ongoing process of facilitating the knowledge, skills, and ability necessary for diabetes self-care.

Supporting self-care is a crucial aspect of any health service, especially the one that targeting diabetes. It has shown a positive effect on the clinical, psychological, and behavioural aspects of diabetics. However, culturally adapted educational services that recognize the context should be established and used carefully, as most of the social media and YouTube educational products are not relevant most of the time.

Diabetic patients who receive no education about their diabetes, are four times as likely to develop complications as those who do not. Oppositely, those who attending diabetes education programs are less likely to develop long-term complications.

The core question of the trial is to find an answer to the question: how the Diabetes self-care information, education provided by trained health care educator at primary care is effective in controlling patterns of blood glucose, reducing BMI, and enhancing self-care behaviour among diabetic patients attending chronic care clinic compared to the control group receiving routine care for diabetes.

详细描述

A pragmatic Trial is a modern approach for testing research hypotheses in real life to draw inspiration from the implemented intervention to inform decision making and change in health policy at the level of primary health care and the community.

The trial outcomes could be used in making new policy that directly contributes to the model of care, health economics, and population health management program. It is a 12 months pragmatic randomized trial that will recruit type II diabetic patients attending primary health care centres in Tabuk city.

Conclusion:

Upon successful completion of the trial, the primary and secondary outcomes of the trial like reduction in the blood glucose level, Body Mass Index (BMI), waist circumference, HbA1c, serum cholesterol level, and blood pressure are expected. Besides, the development of new recommendations for diabetes self-care policy, model of care, and on-the-job training at primary health care.

Sample size calculation:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • The participants were type II diabetic patients of both genders attending the selected primary health care centers irrespective of their duration of disease and the types of medication currently received. The participants were adults aged 18 years and above.

排除标准

  • Children and young adults with juvenile diabetes mellitus were excluded. In addition, severely ill patients, patients with mental disorders were also excluded.

结局指标

主要结局

To compare the mean differences in the: Blood glucose level, BMI, Waist circumference between intervention and control groups

时间窗: 12 months

A reduction in the average blood glucose level, BMI, waist circumference over12 months' duration.

次要结局

  • To compare the mean differences in the: HbA1C, Serum cholestrol, and blood pressure between intervention and control groups(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fakhralddin Abbas Mohammed Elfakki

Assistant Professor of Preventive Medicine and Epidemiology

University of Tabuk

研究点 (2)

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