Clinical trial NCT03956160: Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform
Official title: Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Caregiver
Support
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 200
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: 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.

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

Primary outcomes:
measure: Participation at 6 months after hospital discharge
timeFrame: 6 months
Secondary outcomes:
measure: Participation at 12 months
timeFrame: 12 months
measure: Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS)
timeFrame: 6 months
measure: Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS)
timeFrame: 12 months
measure: Anxiety and depression scores at 6 months after hospital discharge
timeFrame: 6 months
measure: Anxiety and depression scores at 12 months after hospital discharge
timeFrame: 12 months
measure: Fatigue at 6 months after hospital discharge
timeFrame: 6 months
measure: Fatigue at 12 months after hospital discharge
timeFrame: 12 months
measure: Sleep quality at 6 months after hospital discharge: Pittsburgh scale
timeFrame: 6 months
measure: Sleep quality at 12 months after hospital discharge: Pittsburgh scale
timeFrame: 12 months
measure: Sleepiness at 6 months after hospital discharge
timeFrame: 6 months
measure: Sleepiness at 12 months after hospital discharge
timeFrame: 12 months
measure: Prognosis at 12 months after hospital discharge (Stroke recurrence)
timeFrame: 12 months
measure: Prognosis at 12 months after hospital discharge (hospitalizations)
timeFrame: 12 months
measure: Prognosis at 12 months after hospital discharge (neurologic disability)
timeFrame: 12 months
measure: Prognosis at 12 months after hospital discharge (death)
timeFrame: 12 months
measure: Cognitive disorders at hospital discharge
timeFrame: 1 day
measure: Cognitive disorders at 12 months after hospital discharge
timeFrame: 12 months
measure: Access to care at 12 months after hospital discharge
timeFrame: 12 months
measure: Access to social services at 12 months after hospital discharge
timeFrame: 12 months
measure: Maintaining hospital discharge prescriptions at 6 months after hospital discharge
timeFrame: 6 months
measure: Maintaining hospital discharge prescriptions at 12 months after hospital discharge
timeFrame: 12 months
measure: Occupational status at 12 months after hospital discharge
timeFrame: 12 months
measure: Social isolation at discharge from hospital
timeFrame: 1 day
measure: Social isolation at 6 months after hospital discharge
timeFrame: 6 months
measure: Social isolation at 12 months after hospital discharge
timeFrame: 12 months
measure: Patient activation level at discharge from hospital
timeFrame: 1 day
measure: Patient activation level at 6 months after hospital discharge
timeFrame: 6 months
measure: Patient activation level at 12 months after hospital discharge
timeFrame: 12 months
measure: Maintenance at home at 12 months after hospital discharge
timeFrame: 12 months
measure: Satisfaction with the support received upon return home: ad-hoc questionnaire
timeFrame: 12 months
measure: Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire
timeFrame: 6 months
measure: Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Julie Haesebaert, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Termoz A, Delvallee M, Damiolini E, Marchal M, Preau M, Huchon L, Mazza S, Habchi O, Bravant E, Derex L, Nighoghossian N, Cakmak S, Rabilloud M, Denis A, Schott AM, Haesebaert J. Co-design and evaluation of a patient-centred transition programme for stroke patients, combining case management and access to an internet information platform: study protocol for a randomized controlled trial - NAVISTROKE. BMC Health Serv Res. 2022 Apr 22;22(1):537. doi: 10.1186/s12913-022-07907-5.