Asmat Kainat, Dhamani Khairunnisa, Froelicher Erika Sivarajan, Gul Raisa
Shifa College of Nursing & Midwifery, Shifa Tameer-e-Millat University, Islamabad, Pakistan.
Department of Physiological Nursing, School of Nursing, Department of Epidemiology & Biostatistics, School of Medicine, University of California, San Francisco, CA, USA.
Diabetes Metab Syndr Obes. 2023 Jan 26;16:225-236. doi: 10.2147/DMSO.S385715. eCollection 2023.
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.
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).
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.
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.
2型糖尿病（DM）及其相关并发症带来的负担日益加重，正在影响个体的功能能力、生活质量以及对医疗服务的需求，对医疗保健系统和国家经济产生重大经济影响。鉴于其巨大的健康和经济影响，预防2型糖尿病进展并降低并发症风险需要立即引起关注。西方国家的证据表明，自我管理可以减缓2型糖尿病的进展，并将主要并发症的风险降至最低，从而降低医疗成本。然而，有效的自我管理需要患者的信心以及他们对执行自我护理任务的充分投入，这需要以患者为中心的方法。本研究旨在测试以患者为中心的自我管理干预措施对改善2型糖尿病成年人血糖控制、自我效能感和自我护理行为的疗效。
本研究将在巴基斯坦费萨拉巴德的四家公立三级护理医院进行平行组随机对照试验。总共将招募612名2型糖尿病患者，并随机分为两组：对照组和干预组。干预组将接受为期八周的以患者为中心的自我管理干预。对受试者进行为期三个月的随访。主要结局将是血糖控制（糖化血红蛋白），次要结局变量将包括自我效能感和自我护理行为，所有这些均在三个时间点（基线、干预结束时和三个月随访时）进行测量。
这项随机对照试验将提供有关以患者为中心的自我管理干预在改善糖化血红蛋白、自我效能感和自我护理行为方面疗效的关键信息。如果成功，这一基于证据的护理干预措施可能会通过更新医院政策提供给所有糖尿病患者。
美国国立医学图书馆（NIH）：clinicaltrials.gov标识符：NCT05491252，希法塔米尔伊米拉特大学方案记录：335 - 21。注册日期：2022年8月8日。招募开始日期：2022年4月21日。招募完成日期：2022年7月27日。网址：http://www.clinicaltrials.gov
