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Clinical Trials/NCT03956160
NCT03956160
Unknown
Not Applicable

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 sites200 target enrollmentDecember 30, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Hospices Civils de Lyon
Enrollment
200
Primary Endpoint
Participation at 6 months after hospital discharge
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 30, 2021
End Date
September 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Participation at 6 months after hospital discharge

Time Frame: 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

Secondary Outcomes

  • 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)

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