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临床试验/NCT03956160
NCT03956160Unknown不适用

Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform

Hospices Civils de Lyon0 个研究点目标入组 200 人开始时间: 2021年12月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
Participation at 6 months after hospital discharge

研究概览

简要总结

Due to the brutality of stroke and increasingly shorter lengths of hospital stay, patients and their families must adapt quickly to the patient's new state of health and the new role of caregiver for family members. Patients and caregivers report a significant need for advice and information during this transition period. Thus, the provision of information through an Internet platform could meet these characteristics, in association with individualised support by a case-manager to ensure continuity of care and improve care pathway.

The investigating team's hypothesis is that, through comprehensive, individualized and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition program, combining an Internet platform and telephone follow-up by a case-manager, could improve patients' level of participation and quality of life.

详细描述

Going back home following a stroke is a key step for the patient and his or her relatives. Due to the brutality of stroke and increasingly shorter lengths of hospital stay, patients and their families must adapt quickly to the patient's new state of health and the new role of caregiver for family members. Currently, 70% of patients return home directly after treatment in a stroke center. Following the acute phase, the patient's care path involves many health and social workers. However, the health care system is complex and difficult for patients and their caregivers to understand. A lack of support during the hospital/home transition has significant negative consequences for the patient (reduced functional prognosis, quality of life and reintegration, increased risk of recurrence) and his or her caregiver (increased perceived burden, decreased quality of life, socio-economic impact).

Patients and caregivers report a significant need for advice and information during this transition period. They are looking for individualized, good quality information and whose nature evolves over time with the needs and recovery of the patient. Thus, the provision of information through an Internet platform could meet these characteristics, in association with individualised support by a case-manager to ensure continuity of care and improve care pathway. In France, no such program has been developed to date for stroke. Existing transition programmes mainly focus on home rehabilitation and do not offer a comprehensive approach to the situation, integrating caregivers. In addition, no programs have been developed in partnership with patients and families to best meet their needs.

The investigator's hypothesis is that, through comprehensive, individualized and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition program, combining an Internet platform and telephone follow-up by a case-manager, could improve patients' level of participation and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Adult patient,
  • Having had a first confirmed, ischemic or hemorrhagic stroke
  • Managed in the participating stroke center
  • Whose return home directly from the stroke center is planned
  • Presenting a modified Rankin score of 1 to 3 when deciding to leave the stroke center
  • Having given its written consent
  • Whose main residence is located in the Rhône department of France
  • Aphasic patients may be included if a caregiver can follow up with the case manager

排除标准

  • Patient residing in an institution prior to stroke
  • Supported in the gerontological field before stroke
  • Inability to communicate by telephone with the case-manager and absence of a caregiver to follow up by telephone with the case-manager

结局指标

主要结局

Participation at 6 months after hospital discharge

时间窗: 6 months

Patient participation score, measured by the score obtained in the "participation" dimension of the stroke-specific quality of life scale: Stroke Impact Scale 6 months after discharge from hospital

次要结局

  • Anxiety and depression scores at 6 months after hospital discharge(6 months)
  • Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS)(6 months)
  • Anxiety and depression scores at 12 months after hospital discharge(12 months)
  • Sleep quality at 12 months after hospital discharge: Pittsburgh scale(12 months)
  • Prognosis at 12 months after hospital discharge (hospitalizations)(12 months)
  • Prognosis at 12 months after hospital discharge (neurologic disability)(12 months)
  • Prognosis at 12 months after hospital discharge (death)(12 months)
  • Maintaining hospital discharge prescriptions at 12 months after hospital discharge(12 months)
  • Participation at 12 months(12 months)
  • Sleep quality at 6 months after hospital discharge: Pittsburgh scale(6 months)
  • Sleepiness at 12 months after hospital discharge(12 months)
  • Prognosis at 12 months after hospital discharge (Stroke recurrence)(12 months)
  • Fatigue at 6 months after hospital discharge(6 months)
  • Sleepiness at 6 months after hospital discharge(6 months)
  • Cognitive disorders at 12 months after hospital discharge(12 months)
  • Access to care at 12 months after hospital discharge(12 months)
  • Access to social services at 12 months after hospital discharge(12 months)
  • Maintaining hospital discharge prescriptions at 6 months after hospital discharge(6 months)
  • Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS)(12 months)
  • Fatigue at 12 months after hospital discharge(12 months)
  • Cognitive disorders at hospital discharge(1 day)
  • Occupational status at 12 months after hospital discharge(12 months)
  • Social isolation at discharge from hospital(1 day)
  • Patient activation level at discharge from hospital(1 day)
  • Patient activation level at 12 months after hospital discharge(12 months)
  • Maintenance at home at 12 months after hospital discharge(12 months)
  • Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire(6 months)
  • Social isolation at 12 months after hospital discharge(12 months)
  • Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire(12 months)
  • Social isolation at 6 months after hospital discharge(6 months)
  • Patient activation level at 6 months after hospital discharge(6 months)
  • Satisfaction with the support received upon return home: ad-hoc questionnaire(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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