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

NCT05928832 | Unknown

• 1 other identifier: 69HCL23_0237
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Participation; Case-manager; Internet information platform

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing the Navistroke program

  Conclusion on the feasibility if the composite criteria is positive, namely: * Inclusion of 30 patients over a period of 4 months. * Realization of at least two exchanges out of the four defined in the follow-up with the case-manager for the 15 patients included in the intervention group. * Maintenance of the intervention during the 6-months study period

  6 months

Secondary Outcomes (12)

• Patients - Quality of life of patients

  6 months

• Patients - Participation score of patients

  6 months

• Patients - Anxiety and depression scores between discharge and 6 months

  6 months

• Patients - Fatigue between discharge and 6 months

  6 months

• Patients - Social isolation between discharge and 6 month

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will receive an information letter on their discharge presenting the follow-up from which they will benefit: call from the case-manager and access to the internet platform.

Other: Follow-up by a case-manager and access to the internet platform

Control group

NO INTERVENTION

Patients randomized to the control group will receive the usual practices

Interventions

Follow-up by a case-manager and access to the internet platform OTHER

Patients in the intervention group receive an information letter on their discharge presenting the follow-up from which they benefit:call from the case-manager and access to the internet platform. The case-manager meets the patient and/or informal caregiver on the day of discharge from hospital. He recontacts the patient and/or informal caregiver within 7 days after returning home. A follow-up is offered to patients and caregivers following their return home, according to the objectives defined during the initial interview. The total duration of the support is 6 months maximum including at least 4 contacts with the case-manager,but this is refined and adapted with the patient, according to needs. Similarly, the frequency and methods (face-to-face or remote) of contact varies according to the needs of the patients and the stage of support, and is defined by the case-manager and patient. Patients and/or informal caregivers is also able to contact the case-manager 'on request'.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• Patients who do not understand French

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Unité Neuro-Vasculaire des Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, 69677, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Julie MD HAESEBAERT

CONTACT

472684905; julie.haesebaert01@chu-lyon.fr

Anne TERMOZ

CONTACT

427856300; anne.termoz@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following publication
• Access Criteria: julie.haesebaert01@chu-lyon.fr

Locations

FR (1)