【ChiCTR2000040292】A nurse-led community-based self-management program for patients with type 2 diabetes mellitus

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基本信息

登记号

ChiCTR2000040292

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-11-27

临床申请受理号

靶点

适应症

Diabetes mellitus

试验通俗题目

A nurse-led community-based self-management program for patients with type 2 diabetes mellitus

试验专业题目

Effectiveness of a nurse-led community-based self-management program for patients with type 2 diabetes mellitus in Western Ethiopia: A pilot study

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临床试验信息

试验目的

1. To determine the rate of eligibility, recruitment, retention, and percentage of missing data at the item level of the questionnaire in a nurse-led community-based DSMES intervention among adult patients with type 2 diabetes and their family caregivers; 2. To estimate the effect sizes of HbA1c, lipid profiles, SBP, DBP, BMI, self-care behaviors, quality of life, and family support behavior for the future full-scale study among adult patients with type 2 diabetes mellitus; 3. To examine the preliminary effect of a nurse-led community-based DSMES on HbA1c, lipid profiles, SBP, DBP, BMI, self-management behaviors, quality of life, and level of family support among adult patients with type 2 diabetes mellitus; 4. To examine the preliminary effect of a nurse-led community-based DSMES on family support behavior among family caregivers of adult patients with type 2 diabetes; 5. To explore the acceptability of DSMES intervention among adult patients with type 2 diabetes mellitus and their family caregivers.

试验分类

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试验类型

随机抽样

试验分期

探索性研究/预试验

随机化

Before the start of subject recruitment, an independent team member who will not involve in subject recruitment and will not have contact with potential participants will generate a randomization list using the online research randomizer software (https://www.randomizer.org/).

盲法

Due to the nature of the intervention, participants and intervention providers could not be blinded. Data collectors will be masked by the group of study participants through coding.

试验项目经费来源

From the university's budget

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-12-01

试验终止时间

2021-09-30

是否属于一致性

入选标准

Patients will be included if: - 1) diagnosed with type 2 diabetes mellitus (the diagnosis will be retrieved from the patient's medical records); 2) aged 18 years or above; 3) came from two selected Kebeles of the city; 4) taking medication treatments (insulin and/or oral hypoglycemic agents); 5) sign a written informed consent to participate in the study. The family member will be included if: - 1) one primary family caregiver; 2) aged 18 years or above; 3) has the willingness to provide support; and 4) living in the same home with the patient.；

排除标准

The patients will be excluded if: - 1) patients with cognitive impairment. The cognitive status of the patients will be retrieved from the medical record of the patient; 2) unable to nominate one family member who can support them in DM management, 3) a pregnant woman with type 2 diabetes. She will be excluded due to possible difficulty in completing the intervention and follow-up related to pregnancy-related physiologic changes, 4) patients with physical impairment like blindness, paralysis, etc. The patients may not be able to attend the DSMES sessions due to these impairments, and 5) unable to speak and understand the Afaan Oromoo language (the local popular spoken language). Since the intervention will be given in the Afaan Oromoo language, the patients unable to speak and understand the language may face the difficulty of continuing the education sessions. The family member will be excluded if: 1) has physical limitations to perform caregiver responsibilities.；

研究者信息

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试验机构

香港理工大學

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