Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Community Health Nursing Department, Faculty of Nursing, Cairo University, Cairo, Egypt.
BMJ Open. 2022 Feb 15;12(2):e049741. doi: 10.1136/bmjopen-2021-049741.
To evaluate the effectiveness of a tailored multidimensional intervention in reducing the care burden of family caregivers of stroke survivors. This intervention considered caregivers' perceived needs and incorporated three evidence-based dimensions (psychoeducation, skill-building and peer support).
A prospective randomised control trial.
A community-based study conducted in Egypt.
A total of 110 caregivers aged ≥18 years who cared for a survivor within 6 months of stroke, with modified Rankin Scale scores of 3-5, and without other physical disabilities or terminal illnesses were recruited between December 2019 and May 2020. Participants were assigned to the intervention group (IG; n=55) and control group (CG; n=55) through open-label, parallel 1:1 randomisation.
The IG was provided with tailored multidimensional interventions for 6 months until November 2020, including three home visits, six home-based telephone calls and one peer-support session. The CG received simple educational instructions at a single visit.
The participants completed the Zarit Burden Interview (primary outcome) and the WHO Quality of Life-BREF (secondary outcome) before the intervention (T0), at 3 months (T1) and at 6 months (T2).
No differences were observed between the characteristics of the groups at baseline (T0). The independent t-test showed no significant differences in the care burden and Quality of Life (QoL) at T1 and T2 between the groups. The intervention had no significant effect on the outcomes between or within groups over time, as shown by the repeated-measures analysis of variance. However, the group and time interaction had significant main effects on caregivers' QoL (psychological and social domains).
The main results showed that participants in the IG did not experience an improvement in the main outcomes. Nevertheless, the improvement in the psychological and social domains may have been attributed to our intervention.
NCT04211662.
评估针对家庭照顾者的量身定制多维干预措施在降低脑卒中幸存者照顾者负担方面的有效性。该干预措施考虑了照顾者的感知需求，并纳入了三个基于证据的维度（心理教育、技能培养和同伴支持）。
前瞻性随机对照试验。
在埃及进行的社区研究。
共招募了 110 名年龄≥18 岁的照顾者，他们在脑卒中后 6 个月内照顾幸存者，改良 Rankin 量表评分为 3-5 分，且无其他身体残疾或绝症。2019 年 12 月至 2020 年 5 月期间，采用开放标签、平行 1:1 随机分组的方法将参与者分配到干预组（IG；n=55）和对照组（CG；n=55）。
IG 在 6 个月内接受了量身定制的多维干预措施，包括 3 次家访、6 次家庭电话随访和 1 次同伴支持会议。CG 在一次就诊时接受了简单的教育指导。
参与者在干预前（T0）、3 个月（T1）和 6 个月（T2）完成了 Zarit 负担量表（主要结局）和世界卫生组织生活质量简表（次要结局）。
在基线（T0）时，两组的特征无差异。独立样本 t 检验显示，两组在 T1 和 T2 时的照顾负担和生活质量无显著差异。重复测量方差分析显示，干预对组间和组内的结果均无显著影响。然而，组间和时间交互对照顾者的生活质量（心理和社会领域）有显著的主要影响。
主要结果显示，干预组参与者的主要结局无改善。然而，心理和社会领域的改善可能归因于我们的干预。
NCT04211662。
