Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform

Stroke Clinical Trial

— NAVISTROKE  

Official title:

Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03956160
• Other study ID #: 69HCL19_0042
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Hospices Civils de Lyon
• Contact: Julie Haesebaert, Dr
• Phone: 4 72 68 49 05
• Email: julie.haesebaert01[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.
4 participatory co-design workshops lasting 4 hours each that will follow a "user-centered design" approach: identification of end-user needs, prototyping/development of the intervention (case-management procedures and platform), iterative improvement, end-user testing. Based on the cognitive social theory underpinning the intervention, scientific literature, an overview of existing organizations and the results of the Stroke 69 and Arthur Tybra studies (patient needs following the acute phase), the advisory committee will: Define the case-manager's profile, and required knowledge and skills Identify the resources and tools to be proposed on the Internet platform Test the tools and content Refine the program evaluation criteria Test and validate the study procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation at 6 months after hospital discharge	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	6 months
Secondary	Participation at 12 months	Participation score at 12 months after discharged home	12 months
Secondary	Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS)	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.	6 months
Secondary	Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS)	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.	12 months
Secondary	Anxiety and depression scores at 6 months after hospital discharge	Change of anxiety and depression scores between discharge home and 6 months measured by the Hospital Anxiety and Depression scale (HADS) score.	6 months
Secondary	Anxiety and depression scores at 12 months after hospital discharge	Change of anxiety and depression scores between discharge home and 12 months measured by the Hospital Anxiety and Depression scale (HADS) score.	12 months
Secondary	Fatigue at 6 months after hospital discharge	Changes in fatigue level measured by the Pichot scale between discharge home and 6 months	6 months
Secondary	Fatigue at 12 months after hospital discharge	Changes in fatigue level measured by the Pichot scale between discharge home and 12 months	12 months
Secondary	Sleep quality at 6 months after hospital discharge: Pittsburgh scale	Sleep quality measured by the Pittsburgh scale between discharge home and 6 months	6 months
Secondary	Sleep quality at 12 months after hospital discharge: Pittsburgh scale	Sleep quality measured by the Pittsburgh scale between discharge home and 12 months	12 months
Secondary	Sleepiness at 6 months after hospital discharge	Sleepiness level measured by the Epworth scale between discharge home and 6 months	6 months
Secondary	Sleepiness at 12 months after hospital discharge	Sleepiness level measured by the Epworth scale between discharge home and 12 months	12 months
Secondary	Prognosis at 12 months after hospital discharge (Stroke recurrence)	Stroke recurrence within 12 months, reported by the patient and/or caregiver and validated by checking the hospitalization report.	12 months
Secondary	Prognosis at 12 months after hospital discharge (hospitalizations)	Unscheduled hospitalizations or emergency room visits within 12 months of discharge from hospital.	12 months
Secondary	Prognosis at 12 months after hospital discharge (neurologic disability)	Modified Rankin Score at 12-month	12 months
Secondary	Prognosis at 12 months after hospital discharge (death)	Death at 12 months	12 months
Secondary	Cognitive disorders at hospital discharge	Cognitive disorders at discharge from hospital measured by the Montreal Cognitive Assessment (MOCA) scale	1 day
Secondary	Cognitive disorders at 12 months after hospital discharge	Cognitive disorders at 12 months measured by the Montreal Cognitive Assessment (MOCA) scale	12 months
Secondary	Access to care at 12 months after hospital discharge	Consumption of care (consultations and hospitalizations) collected from the regional health insurance database	12 months
Secondary	Access to social services at 12 months after hospital discharge	Requests for social support made	12 months
Secondary	Maintaining hospital discharge prescriptions at 6 months after hospital discharge	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.	6 months
Secondary	Maintaining hospital discharge prescriptions at 12 months after hospital discharge	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.	12 months
Secondary	Occupational status at 12 months after hospital discharge	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.	12 months
Secondary	Social isolation at discharge from hospital	Social isolation at discharge from hospital measured by the Social Support score Questionnaire 6	1 day
Secondary	Social isolation at 6 months after hospital discharge	Social isolation at 6 months after discharge from hospital measured by the Social Support score	6 months
Secondary	Social isolation at 12 months after hospital discharge	Social isolation at 12 months after discharge from hospital measured by the Social Support score	12 months
Secondary	Patient activation level at discharge from hospital	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).	1 day
Secondary	Patient activation level at 6 months after hospital discharge	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).	6 months
Secondary	Patient activation level at 12 months after hospital discharge	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).	12 months
Secondary	Maintenance at home at 12 months after hospital discharge	Data concerning the patient's place of residence 12 months after hospital discharge will be collected by interviewing the patient	12 months
Secondary	Satisfaction with the support received upon return home: ad-hoc questionnaire	Satisfaction with the support received upon return home, measured at 12 months by an ad-hoc questionnaire	12 months
Secondary	Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire	Feeling of information about stroke and medical and social care at 6 months through an ad-hoc questionnaire	6 months
Secondary	Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire	Feeling of information about stroke and medical and social care at 12 months through an ad-hoc questionnaire	12 months