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双元应对干预社会参与对脑卒中幸存者有效性的随机对照试验研究方案。

Effectiveness of the Dyadic Coping Intervention of Social Participation (DCISP) for stroke survivors: study protocol for a randomized controlled trial.

机构信息

School of Nursing, Shanghai University of Traditional Chinese Medicine, No.1200 Cailun road, Pudong New Area, Shanghai, 201203, China.

出版信息

BMC Psychol. 2024 Sep 27;12(1):500. doi: 10.1186/s40359-024-01994-1.

Abstract

BACKGROUND

Enhancing social participation is not only the main goal of stroke survivors' community rehabilitation but also a protective factor affecting their physical and emotional health. The current state of stroke survivors' social participation is not encouraging due to the high disability incidence of stroke. Spouses may play a facilitating role in the social participation of patients by providing them with support and assistance. However, there remains a lack of evidence specifically regarding dyadic coping interventions of social participation for stroke survivors, and the intervention strategies are still underdeveloped without clear theoretical frameworks. Therefore, this proposed study aims to develop and evaluate the effectiveness of the Dyadic Coping Intervention of Social Participation (DCISP) for survivors of first-episode homebound stroke.

METHODS

A single-blind (assessor-blinded), randomized controlled trial will be conducted to verify the effectiveness of DCISP. The randomized controlled trial will be preceded by a feasibility study (N = 20) of DCISP in stroke survivors. Stroke survivors will be randomly classified (1:1) into either a control (N = 50) or an experimental group (N = 50). In addition to routine care, participants in the experimental group will receive six 40 ~ 45 min sessions of guidance, once every two weeks. The primary outcome is social participation of stroke survivors, measured using Impact on Participation and Autonomy Questionnaire (IPA) and Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), and the secondary outcomes will be measured by Knowledge Questionnaire for Stroke Patients (SPKQ), Stroke-specific Quality of Life Scale (SS-QOL), Dyadic Coping Inventory (DCI), Modified Rankin Scale (mRS) and Zarit Caregiver Burden Interview (ZBI-22). These will be measured at baseline(T0), during the intervention (T1 = 1 month), and after intervention completion (T2 = 3 months, T3 = 6 months).

DISCUSSION

Findings from the study will provide evidence of the effects of DCISP on improving the social participation of first-episode homebound stroke survivors. The results of this study may support the implementation of survivor-spouse dyads care support in stroke survivors and provide a reference for clinical rehabilitation nursing practice, offering new insights into nursing interventions for stroke patients.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR) ChiCTR2400083072. Registered on 20 July 2023.

摘要

背景

提高社会参与度不仅是脑卒中幸存者社区康复的主要目标,也是影响其身心健康的保护因素。由于脑卒中的高致残率,脑卒中幸存者的社会参与现状不容乐观。配偶可以通过提供支持和帮助,在患者的社会参与中发挥促进作用。然而,目前针对脑卒中幸存者的夫妻应对社会参与的干预措施,还缺乏具体的证据,干预策略也不发达,没有明确的理论框架。因此,本研究旨在为首次居家脑卒中幸存者开发和评估夫妻应对社会参与干预(Dyadic Coping Intervention of Social Participation,DCISP)的效果。

方法

采用单盲(评估者盲)、随机对照试验来验证 DCISP 的有效性。在对脑卒中幸存者进行 DCISP 的可行性研究(N=20)之前,将进行一项随机对照试验。脑卒中幸存者将被随机分为对照组(N=50)或实验组(N=50)。除常规护理外,实验组参与者还将接受 6 次 40~45 分钟的指导,每两周一次。主要结局是脑卒中幸存者的社会参与度,使用参与和自主问卷(Impact on Participation and Autonomy Questionnaire,IPA)和康复参与评定量表(Utrecht Scale for Evaluation of Rehabilitation-Participation,USER-P)进行测量,次要结局将使用脑卒中患者知识问卷(Knowledge Questionnaire for Stroke Patients,SPKQ)、脑卒中特定生活质量量表(Stroke-specific Quality of Life Scale,SS-QOL)、夫妻应对量表(Dyadic Coping Inventory,DCI)、改良 Rankin 量表(Modified Rankin Scale,mRS)和照顾者负担量表(Zarit Caregiver Burden Interview,ZBI-22)进行测量。这些将在基线(T0)、干预期间(T1=1 个月)和干预完成后(T2=3 个月,T3=6 个月)进行测量。

讨论

该研究的结果将为提高首次居家脑卒中幸存者的社会参与度的 DCISP 效果提供证据。该研究的结果可能支持在脑卒中幸存者中实施幸存者-配偶二联体的护理支持,并为临床康复护理实践提供参考,为脑卒中患者的护理干预提供新的思路。

试验注册

中国临床试验注册中心(ChiCTR),ChiCTR2400083072。注册于 2023 年 7 月 20 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6091/11437903/3c5a977a56db/40359_2024_1994_Fig1_HTML.jpg

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