Department Of Community Medicine and Family Medicine, All India Institute of Medical Sciences, Bhubaneswar, India.
Department Of Community Medicine, Institute of Medical Sciences & SUM Hospital, Bhubaneswar, India.
Trials. 2024 Jan 3;25(1):22. doi: 10.1186/s13063-023-07824-w.
The main contributors to death and disability from chronic illnesses in developing nations are elevated blood pressure (hypertension), blood sugar (diabetes mellitus), and blood cholesterol (dyslipidaemia). Even though there are affordable treatments, the treatment gap for these conditions is still significant. Few pilot studies from industrialized nations discuss the value of peer-led interventions for achieving community-level management of blood pressure and blood sugar. This study aims to evaluate the effectiveness of peer-led intervention compared to standard care in achieving control of selected non-communicable diseases (NCDs) in Indian context at 1 year of intervention among people of 30-60 years with hypertension and/or diabetes mellitus and/or dyslipidaemia.
A cluster-randomized controlled trial will be conducted in villages of two rural blocks of the Khordha district of Odisha from August 2023 to December 2024. A total of 720 eligible participants (360 in the intervention group and 360 in the control group) will be recruited and randomized into two study arms. The participants in the intervention arm will receive a peer-led intervention model for 6 months in addition to standard care. The sessions will be based on the six domains of NCDs - self-care, follow-up care, medication, physical activity, diet, limiting substance use, mental health and co-morbidities. The mean reduction in blood pressure, HbA1C, and blood cholesterol in the intervention arm compared to the standard care arm will be the main outcome.
The increasing burden of NCDs demands for newer strategies for management. Peer-led interventions have proven to be useful at the international level. Incorporating it in India will have remarkable results in controlling NCDs.
Clinical Trial Registry of India (CTRI) CTRI/2023/02/050022. Registered on 23 February 2023.
在发展中国家,导致死亡和残疾的主要因素是高血压(hypertension)、高血糖(diabetes mellitus)和高胆固醇血症(dyslipidaemia)。尽管有负担得起的治疗方法,但这些疾病的治疗差距仍然很大。很少有来自工业化国家的试点研究探讨同伴主导干预在实现社区层面管理血压和血糖方面的价值。本研究旨在评估同伴主导干预在印度背景下,与标准护理相比,在控制高血压和/或糖尿病和/或高胆固醇血症的 30-60 岁人群中,在 1 年的干预中对选定的非传染性疾病(NCDs)的有效性。
本研究将在 2023 年 8 月至 2024 年 12 月期间在奥里萨邦 Khordha 区的两个农村街区的村庄进行一项基于群组的随机对照试验。将招募并随机分配共 720 名符合条件的参与者(干预组 360 名,对照组 360 名)进入两个研究组。干预组的参与者将在标准护理的基础上接受为期 6 个月的同伴主导干预模式。课程将基于 NCDs 的六个领域 - 自我护理、随访护理、药物治疗、体育活动、饮食、限制物质使用、心理健康和合并症。干预组与标准护理组相比,血压、HbA1C 和血胆固醇的平均降低将是主要结果。
NCDs 的负担不断增加,需要新的管理策略。同伴主导的干预措施已被证明在国际上是有效的。将其纳入印度将在控制 NCDs 方面产生显著效果。
印度临床试验注册处(CTRI)CTRI/2023/02/050022。于 2023 年 2 月 23 日注册。