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

NCT03956160 | Unknown

• 1 other identifier: 69HCL19_0042
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

Caregiver; Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Participation at 12 months

  12 months

• Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS)

  6 months

• Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS)

  12 months

• Anxiety and depression scores at 6 months after hospital discharge

  6 months

• Anxiety and depression scores at 12 months after hospital discharge

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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.

Interventions

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

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Related Publications (1)

• 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.

  PMID: 35459183 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Julie Haesebaert, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Haesebaert, Dr

CONTACT

4 72 68 49 05; julie.haesebaert01@chu-lyon.fr

Anne Termoz

CONTACT

4 27 85 63 00; 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: May 15, 2019
• First Posted: May 20, 2019
• Study Start: December 30, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

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