Clinical trial NCT05928832: Evaluation of the Feasibility of a Patient-centered Transition Program for Stroke Patients and Their Informal Caregivers, Combining Follow-up by a Case-manager and Access to an Internet Information Platform
Official title: Evaluation of the Feasibility of a Patient-centered Transition Program for Stroke Patients and Their Informal Caregivers, Combining Follow-up by a Case-manager and Access to an Internet Information Platform
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Participation
Case-manager
Internet information platform
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 families must adapt quickly to the patient's new state of health and the new role of informal 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 informal 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 informal caregiver (increased perceived burden, decreased quality of life, socio-economic impact).

Patients and informal 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 individualized 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 programs 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 needs.

An hospital-to-home transition support program in partnership with patients and relatives using a "user-centered design" approach has been developed in order to best meet needs.

A first phase of co-construction has been conducted while 4 participatory workshops for (patients, informal caregivers, healthcare assistants and professionals in the social field) were carried out to precisely define and develop the program. The program was developed in based on data from the scientific literature, an inventory of existing systems and the experience of participants. During this phase a usability testing of the platform developed during the workshops with patients and informal caregivers following a Think Aloud method has also been conducted.

The hypothesis is that the implementation of this patient-centered post-stroke hospital/home transition program, combining an Internet platform and follow-up by a case-manager, is feasible within stroke center and will receive good acceptability from healthcare professionals, patients and informal caregivers.


Eligibility criteria: Inclusion Criteria:

For patients:

* Adult patient,
* Having had a first confirmed, ischemic or hemorrhagic stroke
* Hospitalized in a participating stroke center,
* Living at home before the stroke,
* 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 (absence of significant disability with moderate disability)
* Having given its written consent
* Whose main residence is located in the Rhône department
* Aphasic patients, who have disorders that limit their ability to communicate by phone with the case-manager will be included in the event of identification of an informal caregiver with telephone support.
* Aphasic patients may be included if an informal caregiver can follow up with the case manager

For informal caregivers:

* Adult patient
* Being a caregiver of a patient agreeing to participate in the NAVISTROKE study,
* Having given their written consent

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
* Pregnant or breastfeeding women,
* Persons deprived of their liberty by a judicial or administrative decision,
* Persons under psychiatric care
* Persons admitted to a health or social establishment for purposes other than research,
* Persons of full age subject to a legal protection measure (guardians, curators),
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme,
* Subjects participating in other intervention research with an exclusion period still in progress at inclusion
* Patients who do not understand French

Primary outcomes:
measure: Feasibility of implementing the Navistroke program
timeFrame: 6 months
Secondary outcomes:
measure: Patients - Quality of life of patients
timeFrame: 6 months
measure: Patients - Participation score of patients
timeFrame: 6 months
measure: Patients - Anxiety and depression scores between discharge and 6 months
timeFrame: 6 months
measure: Patients - Fatigue between discharge and 6 months
timeFrame: 6 months
measure: Patients - Social isolation between discharge and 6 month
timeFrame: 6 months
measure: Patients - Satisfaction
timeFrame: 6 months
measure: Patients - Information feeling
timeFrame: 6 months
measure: Informal caregivers - Evolution of the quality of life between the patient's discharge from hospital and 6 months
timeFrame: 6 months
measure: Informal caregivers - Level of perceived burden
timeFrame: 6 months
measure: Informal caregivers - Evolution of the global anxiety-depression score between discharge and 6 months after the patient's discharge from hospital
timeFrame: 6 months
measure: Informal caregivers - Satisfaction with the support and information received when returning home
timeFrame: 6 months
measure: Informal caregivers - Information feeling
timeFrame: 6 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Unité Neuro-Vasculaire des Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Study officials:
References: