A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults with Type 2 Diabetes Mellitus: A SPIRIT Compliant Study Protocol for Randomized Controlled Trial

BACKGROUND: The rising burden of type 2 diabetes mellitus (DM) and its associated complications is affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care systems and the national economies. Given the enormous health and economic impact, preventing type 2 DM progression and reducing the risk of complications require immediate attention. Evidence from western countries suggests that self-management can slow the progression of type 2 DM and minimize the risk of major complications lowering health-care costs. Effective self-management, however, demands patients’ confidence and their full commitment to perform self-care tasks necessitating a patient-centered approach. This study aims to test the efficacy of a patient-centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM. PATIENTS AND METHODS: The study will be carried out as a parallel arm, randomized, controlled trial in four public tertiary care hospitals in Faisalabad, Pakistan. A total of 612 patients with type 2 DM will be recruited and randomly assigned to two groups: a control and an intervention group. The intervention group will receive a patient-centered self-management intervention for eight weeks duration. Subjects will be followed up for three months. The primary outcome will be glycemic control (HbA1c), and secondary outcome variables will include self-efficacy and self-care behaviors all measured at three points in time (baseline, at the end of intervention and at three months follow-up). DISCUSSION: This randomized controlled trial will provide critical information about the efficacy of patient-centered self-management intervention in improving HbA1c, self-efficacy and self-care behaviors. If successful, this evidence-based care intervention may be provided to all DM patients by updating hospital policies. TRIAL REGISTRATION: NIH: US National Library of Medicine clinicaltrials.gov Identifier: NCT05491252, Shifa Tameer e Millat University Protocol Record: 335-21. Registration date: August 08, 2022. Recruitment began: April 21, 2022. Recruitment completed: July 27, 2022. URL http://www.clinicaltrials.gov.