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临床试验/NCT05646589
NCT05646589已完成不适用

Implementation and Evaluation of a Person-centred Care Transition Support for People With Stroke/TIA

Karolinska Institutet3 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
213
试验地点
3
主要终点
Care Transition Measure

研究概览

简要总结

The goal of this clinical trial is to test a person-centred care transition support in people with stroke/TIA. The main questions it aims to answer are:

  • Does a multi-component care transition intervention have an effect on perceived quality of care transitions, health literacy, collected medications, medication adherence, perceived person-centeredness, functioning, recurrent stroke/TIA, healthcare utilization and caregiver burden?
  • What are the experiences of the intervention components and the implementation process?
  • How does the intervention get adapted and implemented in practice?
  • What contextual moderators and mechanisms of the intervention can likely explain the potential effects of the intervention?

Participants will receive a person-centred care transition support that includes a set of activities targeting how healthcare professionals can improve quality with care transition and support health literacy for self-management of secondary stroke prevention for persons who are to be discharged from hospitals after stroke or TIA.

Researchers will compare participants who receive the person-centred care transition support with participants receiving regular care transitions to see if the person-centred care transition support has any effects on perceived quality of care transitions, health literacy, collected medications, medication adherence, perceived person-centeredness, functioning, recurrent stroke/TIA, healthcare utilization and caregiver burden.

详细描述

Care transitions following a stroke call for integrated care approaches to reduce death and disability. The proposed research described in this study protocol aims to evaluate the ef-fectiveness of a person-centred multicomponent care transition support and the process in terms of contextual moderators, implementation aspects and mechanisms of impact.

A non-randomized controlled trial design will be used. The intervention includes person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming.

Patients with stroke or TIA who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation will be included. Follow-ups will be conducted at one week, 3 months and 12 months. Data will be collected on the primary outcome of perceived quality of the care transition, and on the secondary outcomes of health literacy, medication adherence, and perceived person-centeredness. Data for process evaluation will be collected through semi-structured interviews, focus groups, partici-patory observations, and the Normalisation Measure Development Questionnaire.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who have had a first time ever or recurrent stroke or TIA; who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation; and who are able to give informed consent by themselves.

排除标准

  • unable to give informed consent, due to e.g., severe aphasia or dementia.

结局指标

主要结局

Care Transition Measure

时间窗: 1 week after discharge from hospital

Questionnaire that assesses perceived quality in care transitions. The total score (0-100) reflects the overall perceived quality of the care transition, with lower scores indicating a poor quality care transition, and higher scores indicating a higher quality care transition

次要结局

  • The Medication Adherence Report Scale (patient)(1 week, 3 and 12 months after inclusion)
  • General Person-centred Care Questionnaire(1 week, 3 and 12 months after inclusion)
  • Stroke Impact Scale, perceived recovery (patient)(inclusion, 1 week, 3 and 12 months after inclusion)
  • EuroQol 5D(1 week and 12 months after inclusion)
  • Stroke Patient Education Retention(1 week, 3 and 12 months after inclusion)
  • Satisfaction with care and rehabilitation(1 week, 3 and 12 months after inclusion)
  • Health Literacy Survey(1 week, 3 and 12 months after inclusion)
  • General Self-Efficacy Scale(12 months after inclusion)
  • Caregiver Burden Scale (significant other)(3 months after inclusion)
  • Life Satisfaction Checklist, item 1 (significant other)(3 months after inclusion)
  • Health Literacy Questionnaire(1 week, 3 and 12 months after inclusion)
  • EuroQol 5D (significant other)(3 months after inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Ytterberg

Lecturer, associate professor (docent)

Karolinska Institutet

研究点 (3)

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