ABSTRACT
AIM: 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. METHODS: 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 selfâ 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. TRIAL REGISTRATION: The Chinese Clinical Trial Registry prospectively registered the trial, and the registration number was ChiCTR2000040292.
