The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, 6/F, Esther Lee Building, Shatin, Hong Kong SAR, China.
Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University, Changsha, China.
BMC Geriatr. 2021 Mar 2;21(1):152. doi: 10.1186/s12877-021-02097-x.
Older patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity.
The study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients' diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention.
This study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients' adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings.
The trial is registered at ChiCTR.org.cn ( ChiCTR2000030011 ; date February 19, 2020).
患有多种疾病的老年患者存在较高的药物治疗不依从风险。自我管理支持已被证实是提高慢性病患者药物治疗依从性的有效策略。然而，对于患有多种疾病的老年患者，药物自我管理干预的效果知之甚少。本文介绍了一项研究的方案，旨在评估护士主导的药物自我管理干预在提高社区居住的患有多种疾病的老年患者药物治疗依从性和健康结局方面的有效性。
研究方案遵循 2013 年干预性试验标准协议项目建议。这是一项多中心、单盲、两臂随机对照试验。将从中国长沙的三个社区卫生中心招募患有多种疾病的老年患者。共有 136 名参与者将被随机分配接受常规护理或常规护理加药物自我管理干预。干预将由社区护士提供。为期 6 周的干预包括三次面对面教育课程和两次每周电话随访。对照组的参与者继续接受社区医疗保健提供者提供的所有常规护理，包括慢性病管理、药物处方、转介到医院专科医生、健康教育以及中心就诊时对患者疾病和治疗的咨询。主要结局是通过 5 项药物治疗依从性报告量表来衡量的药物治疗依从性。次要结局包括药物自我管理能力（药物知识、药物信念、药物社会支持、药物技能和药物自我效能）、治疗体验（药物治疗满意度和治疗负担）、生活质量和医疗服务利用情况。所有结局都将在基线、干预后立即和干预后 3 个月进行测量。
本研究将为患有多种疾病和依从性问题的老年患者提供护士提供的药物自我管理干预的有效性证据。如果该研究结果被证明能有效提高患者的依从性和健康结局，预计将为社区常规慢性病管理中的医疗保健提供者提供基于证据的自我管理支持策略。
该试验在中国临床试验注册中心注册（ChiCTR2000030011；日期为 2020 年 2 月 19 日）。
