Randomised controlled trial on the effect of social support on disease control, mental health and health-related quality of life in people with diabetes from Côte d’Ivoire: the SoDDiCo study protocol

Autor: Günther Fink, Nicole Probst-Hensch, Sonja Merten, Jürg Utzinger, Marek Kwiatkowski, Franck Kokora Ekou, Ikenna C Eze, Joseph Aka, Felix Kouamé Acka
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMJ Open, Vol 14, Iss 1 (2024)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2022-069934
Popis: Introduction Diabetes mellitus (DM) and its severe complications contribute significantly to disability and, hence, burden of disease. Poor mental health, a frequent DM consequence, may hinder successful diabetes control in low-income and middle-income countries (LMICs). Evidence suggests social support as a cost-effective tool to improve diabetes self-management, behaviour and mental health. However, its real-world application in LMICs has rarely been tested. We aim to investigate the effect of a social support intervention on disease control, mental health and health-related quality of life in people with diabetes from Côte d’Ivoire (SoDDiCo) through a randomised controlled trial.Methods and analysis The trial will take place in the Centre Antidiabétique d’Abidjan, Institut National de Santé Publique, Abidjan, Côte d’Ivoire. We will prospectively randomise up to 1500 people with newly diagnosed diabetes into two parallel arms: intervention (routine care+family supporter accompanying clinical management) and control (routine care), using gender-stratified blocked randomisation with random block sizes of 10, 16, 20 and 24. Participants will undergo baseline, 3-month and 12-month postrandomisation assessments. The primary study outcome will be glycated haemoglobin (HbA1c). Secondary outcomes will include glycaemic control (HbA1c
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