Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform
- Conditions
- Stroke
- Interventions
- Other: A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.
- Registration Number
- NCT03956160
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation. For 12 months from the return home, patients in the intervention group will benefit from telephone support by a trained case-manager (number and frequency of contacts defined according to the patient's needs) and access to an Internet platform. The intervention aims to improve the patient's ability to manage his or her situation and meet his or her needs upon return home, including identifying and requesting the necessary health or social resources.
- Primary Outcome Measures
Name Time Method Participation at 6 months after hospital discharge 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 Outcome Measures
Name Time Method Anxiety and depression scores at 6 months after hospital discharge 6 months Change of anxiety and depression scores between discharge home and 6 months measured by the Hospital Anxiety and Depression scale (HADS) score.
Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS) 6 months Score of the other dimensions of the Stroke Impact Scale (SIS) at 6 months: force dimension, manual function, daily activities, mobility, communication, emotions, memory/thinking and global recovery.
Anxiety and depression scores at 12 months after hospital discharge 12 months Change of anxiety and depression scores between discharge home and 12 months measured by the Hospital Anxiety and Depression scale (HADS) score.
Sleep quality at 12 months after hospital discharge: Pittsburgh scale 12 months Sleep quality measured by the Pittsburgh scale between discharge home and 12 months
Prognosis at 12 months after hospital discharge (hospitalizations) 12 months Unscheduled hospitalizations or emergency room visits within 12 months of discharge from hospital.
Prognosis at 12 months after hospital discharge (neurologic disability) 12 months Modified Rankin Score at 12-month
Prognosis at 12 months after hospital discharge (death) 12 months Death at 12 months
Maintaining hospital discharge prescriptions at 12 months after hospital discharge 12 months Therapeutic persistence: maintenance of therapeutic prescriptions for discharge from hospital at 12 months. The prescriptions for secondary preventive treatment of stroke will be considered. Data will be collected by interviewing the patient.
Participation at 12 months 12 months Participation score at 12 months after discharged home
Sleep quality at 6 months after hospital discharge: Pittsburgh scale 6 months Sleep quality measured by the Pittsburgh scale between discharge home and 6 months
Sleepiness at 12 months after hospital discharge 12 months Sleepiness level measured by the Epworth scale between discharge home and 12 months
Prognosis at 12 months after hospital discharge (Stroke recurrence) 12 months Stroke recurrence within 12 months, reported by the patient and/or caregiver and validated by checking the hospitalization report.
Fatigue at 6 months after hospital discharge 6 months Changes in fatigue level measured by the Pichot scale between discharge home and 6 months
Sleepiness at 6 months after hospital discharge 6 months Sleepiness level measured by the Epworth scale between discharge home and 6 months
Cognitive disorders at 12 months after hospital discharge 12 months Cognitive disorders at 12 months measured by the Montreal Cognitive Assessment (MOCA) scale
Access to care at 12 months after hospital discharge 12 months Consumption of care (consultations and hospitalizations) collected from the regional health insurance database
Access to social services at 12 months after hospital discharge 12 months Requests for social support made
Maintaining hospital discharge prescriptions at 6 months after hospital discharge 6 months Therapeutic persistence: maintenance of therapeutic prescriptions for discharge from hospital at 6 months. The prescriptions for secondary preventive treatment of stroke will be considered. Data will be collected by interviewing the patient.
Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS) 12 months Score of the other dimensions of the Stroke Impact Scale (SIS) at 12 months: force dimension, manual function, daily activities, mobility, communication, emotions, memory/thinking and global recovery.
Fatigue at 12 months after hospital discharge 12 months Changes in fatigue level measured by the Pichot scale between discharge home and 12 months
Cognitive disorders at hospital discharge 1 day Cognitive disorders at discharge from hospital measured by the Montreal Cognitive Assessment (MOCA) scale
Occupational status at 12 months after hospital discharge 12 months Occupational status at 12 months: return to work will be defined by working at least one day per week. Among these patients, resumption of the same professional activity, professional reclassification or adapted working time, early retirement.
Social isolation at discharge from hospital 1 day Social isolation at discharge from hospital measured by the Social Support score Questionnaire 6
Patient activation level at discharge from hospital 1 day Patient activation will be measured by the score obtained at the "Patient activation Measure" scale. This questionnaire is composed of 22 items that assess the patient's knowledge, skills and confidence level to manage their own situation (self-management).
Patient activation level at 12 months after hospital discharge 12 months Patient activation will be measured by the score obtained at the "Patient activation Measure" scale. This questionnaire is composed of 22 items that assess the patient's knowledge, skills and confidence level to manage their own situation (self-management).
Maintenance at home at 12 months after hospital discharge 12 months Data concerning the patient's place of residence 12 months after hospital discharge will be collected by interviewing the patient
Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire 6 months Feeling of information about stroke and medical and social care at 6 months through an ad-hoc questionnaire
Social isolation at 12 months after hospital discharge 12 months Social isolation at 12 months after discharge from hospital measured by the Social Support score
Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire 12 months Feeling of information about stroke and medical and social care at 12 months through an ad-hoc questionnaire
Social isolation at 6 months after hospital discharge 6 months Social isolation at 6 months after discharge from hospital measured by the Social Support score
Patient activation level at 6 months after hospital discharge 6 months Patient activation will be measured by the score obtained at the "Patient activation Measure" scale. This questionnaire is composed of 22 items that assess the patient's knowledge, skills and confidence level to manage their own situation (self-management).
Satisfaction with the support received upon return home: ad-hoc questionnaire 12 months Satisfaction with the support received upon return home, measured at 12 months by an ad-hoc questionnaire