Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, P.R. China.
Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yat-sen University, No.135 Xingang West Road, Guangzhou, 510275, P.R. China.
BMC Geriatr. 2020 Mar 30;20(1):123. doi: 10.1186/s12877-020-01528-5.
China's limited health care resources cannot meet the needs of chronic disease treatment and management of its rapid growing ageing population. The improvement and maintenance of patient's self-management is essential to disease management. Given disease management mainly occurs in the context of family, this study proposes to validate a Couple-based Collaborative Management Model of chronic diseases that integrates health professionals and family supporters; such as to empower the couples with disease management knowledge and skills, and to improve the couples' health and quality of life.
The proposed study will validate a couple-based collaborative management model of Type 2 Diabetes Mellitus (T2DM) in a community-based multicenter, two-arm, randomized controlled trial of block design in Guangzhou, China. Specifically, 194 T2DM patients aged ≥55 and their partners recruited from community health care centers will be randomized at the patient level for each center at a 1:1 ratio into the couple-based intervention arm and the individual-based control arm. For the intervention arm, both the patients and their spouses will receive four-weekly structured group education & training sessions and 2 months of weekly tailored behavior change boosters; while these interventions will be only provided to the patients in the control group. Behavior change incentives will be targeted at the couples or only at the patient respectively. Treatment effects on patients' hemoglobin, spouses' quality of life, alongside couples' behavior outcomes will be compared between arms. Study implementation will be evaluated considering its Reach, Effectiveness, Adoption, Implementation and Maintenance following the RE-AIM framework.
This study will generate a model of effective collaboration between community health professionals and patients' family, which will shield light on chronic disease management strategy for the increasing ageing population.
Chinese Clinical Trial Registry, ChiCTR1900027137, Registered 1st Nov. 2019.
中国有限的医疗保健资源无法满足快速老龄化人口的慢性病治疗和管理需求。改善和维持患者的自我管理对于疾病管理至关重要。鉴于疾病管理主要发生在家庭环境中，本研究提出验证一种基于夫妻的慢性病协同管理模式，该模式整合了卫生专业人员和家庭支持者；为夫妻提供疾病管理知识和技能，提高夫妻的健康和生活质量。
本研究将在中国广州的社区为基础的多中心、两臂、随机对照试验中，以区块设计验证一种基于夫妻的 2 型糖尿病（T2DM）协同管理模式。具体来说，将从社区卫生保健中心招募 194 名年龄≥55 岁的 T2DM 患者及其伴侣，按每个中心的 1:1 比例，按患者水平随机分为基于夫妻的干预组和基于个体的对照组。对于干预组，患者及其配偶将接受为期四周的结构化小组教育和培训课程，以及两个月每周的定制行为改变助推器；而这些干预措施将仅在对照组中提供给患者。行为改变激励措施将分别针对夫妻或仅针对患者。将比较两组治疗效果，即患者的血红蛋白、配偶的生活质量以及夫妻的行为结果。根据 RE-AIM 框架，将评估研究实施情况，包括可及性、效果、采用、实施和维持。
本研究将产生一种社区卫生专业人员与患者家属之间有效合作的模式，为不断增加的老年人口的慢性病管理策略提供启示。
中国临床试验注册中心，ChiCTR1900027137，注册于 2019 年 11 月 1 日。
