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

NCT ID: NCT03956160

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2022-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.

Intervention Type: OTHER

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.

Control group

Patients randomized to the control group will receive the usual practices. As part of the study, they will be contacted for data collection upon their return home, at 6 months and 12 months by a clinical research associate.

Access to the internet platform and an interview with the case-manager will be offered at the end of the study to patients in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Haesebaert, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Central Contacts

Julie Haesebaert, Dr

Role: CONTACT

julie.haesebaert01@chu-lyon.fr

4 72 68 49 05 ext. 33

Anne Termoz

Role: CONTACT

anne.termoz@chu-lyon.fr

4 27 85 63 00 ext. 33

References

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.

Reference Type: DERIVED

PMID: 35459183 (View on PubMed)

Other Identifiers

69HCL19_0042

Identifier Type: -

Identifier Source: org_study_id