C Diriba Dereje, Leung Doris Y P, Suen Lorna K P
School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.
School of Nursing, Tung Wah College, Kowloon, Hong Kong.
Diabet Med. 2021 Aug;38(8):e14587. doi: 10.1111/dme.14587. Epub 2021 May 8.
To develop and examine the preliminary effects of a nurse-led, community-based diabetes self management education and support program on clinical outcomes, self care behaviours, quality of life and family support through a pilot randomized controlled trial among adults living with type 2 diabetes in Western Ethiopia.
A two-arm parallel-group pilot randomized controlled trial involving participant-caregiver dyads will be conducted. A total of 76 dyads will be recruited, with 38 dyads randomly allocated to the intervention arm receiving six sessions of the diabetes self management education and support program supported by an educational handbook, flier and video on top of the usual care; the control arm will continue to receive the usual care. The intervention will be guided by social cognitive theory and related international guidelines for diabetes management, addressing misconceptions, using culturally tailored foods and involving family members in the intervention. Participants will be recruited at Nekemte Specialized Hospital over 2 months. Nurses will deliver the intervention in the community in Nekemte, western Ethiopia. Diabetes self care behaviour, quality of life, family support, glycosylated haemoglobin, body mass index, blood pressure and lipid profiles will be assessed. Descriptive statistics will summarize the sociodemographic variables of the dyads; people living with diabetes' clinical outcomes, self care behaviours, quality of life and the level of family support; family caregivers' behaviours; and the acceptability level. Cohen's d will be computed to estimate the effect size.
The Chinese Clinical Trial Registry prospectively registered the trial, and the registration number was ChiCTR2000040292.
通过在埃塞俄比亚西部患有2型糖尿病的成年人中进行一项试点随机对照试验，开发并检验一项由护士主导、基于社区的糖尿病自我管理教育与支持项目对临床结局、自我护理行为、生活质量和家庭支持的初步效果。
将进行一项涉及参与者-照顾者二元组的双臂平行组试点随机对照试验。总共将招募76个二元组，其中38个二元组将被随机分配到干预组，接受六次糖尿病自我管理教育与支持项目，该项目由一本教育手册、传单和视频提供支持，同时接受常规护理；对照组将继续接受常规护理。干预将以社会认知理论和相关糖尿病管理国际指南为指导，解决误解，使用符合文化习惯的食物，并让家庭成员参与干预。将在2个月内在内克梅特专科医院招募参与者。护士将在埃塞俄比亚西部内克梅特的社区提供干预。将评估糖尿病自我护理行为、生活质量、家庭支持、糖化血红蛋白、体重指数、血压和血脂谱。描述性统计将总结二元组的社会人口统计学变量；糖尿病患者的临床结局、自我护理行为、生活质量和家庭支持水平；家庭照顾者的行为；以及可接受程度。将计算科恩d值以估计效应大小。
中国临床试验注册中心对该试验进行了前瞻性注册，注册号为ChiCTR2000040292。
