Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study

NCT04197258 | Recruiting

• 1 other identifier: 69HCL19_0233
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 in-hospital lengths of stay, patients and their families must adapt quickly to the patient's new health functioning and the new caregiving and support role for family members. Peer support could be an innovative and inexpensive approach to addressing these issues. Peer-helpers are patient-partners who put their experiential knowledge from life with the disease at the disposal of other patients to offer them social and emotional support in the management of the disease in connection with care, social and community structures. Group peer support programs face organizational challenges and fail to address the full range of patient needs for stroke home visits. Individualized and more flexible support could better meet the needs of patients. Our hypothesis is that individual peer support improves quality of life and patient empowerment during the discharge period compared to usual practice.

Conditions

Stroke

Keywords

Stroke; Peer support

Outcome Measures

Primary Outcomes (1)

• Feasibility measure

  The feasibility of the intervention will be evaluated as success with a combined criteria including: * Recruitment and training of 2 peer helpers, * Support offered to 20 patients by the peer helpers during the intervention period defined by at least one meeting before and one contact after discharge per patient included in period after, * Good acceptability by patients, carers and peer helpers. These data will be collected by a qualitative approach associating semi-directive interviews, focus groups and participant observation.

  6 months

Secondary Outcomes (15)

• Quality of life between the discharge from hospital and 6 months

  6 months

• Quality of life between the discharge from hospital and 6 months

  6 months

• Quality of life between the discharge from hospital and 6 months

  6 months

• Quality of life between the discharge from hospital and 6 months

  6 months

• Quality of life between the discharge from hospital and 6 months

  6 months

Study Arms (2)

intervention group

EXPERIMENTAL

For 6 months after discharge, patients in the intervention group will benefit from peer support by a trained patient (number and frequency of contacts defined according to the patient's needs). The intervention aims to improve the patient's ability to manage his or her situation and meet his or her needs upon discharge at home, including identifying and seeking for the necessary health or social resources

Other: Peer support

control group

NO INTERVENTION

Patients included in the control group before intervention will receive the usual practices. As part of the study, they will be contacted for data collection 6 months after the transition to home by a clinical research associate.

Interventions

Peer support OTHER

The intervention studied is the psycho-social support by a peer-helper to the patients and their main informal caregiver during the return home following a stay in rehabilitation center for a stroke. Peer support intervention will be based on evidence, Bandura's social learning and social support theory, and the results of our ongoing study of the needs of patients and their caregivers as a result of returning home (Stroke69). It will include a meeting before the discharge and a regular follow-up for 6 months (face-to-face meetings, virtual or by phone), adapted to the needs of the patient and his caregiver, taking into account the social environment and in connection with the devices existing sanitary and social.

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 rehabilitation center
• Whose discharge to home directly from the rehabilitation 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
• Aphasic patients may be included if a caregiver can follow up with the case manager

You may not qualify if:

• Patient living in an institution prior to stroke
• included in a gerontological network before stroke
• Patient unable to understand quality of life questionnaires
• Patient with unstable medical or psychological conditions who, in the opinion of the investigator, could lead the subject to be non-compliant or uncooperative during the study or could compromise patient safety or participation in the study
• Patient under guardianship or curatorship
• Patient not affiliated to a social health insurance

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Julie Haesebaert, MD

CONTACT

472684905; julie.haesebaert01@chu-lyon.fr

Anne Termoz

CONTACT

427856300; anne.termoz@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 13, 2019
• Study Start: October 9, 2020
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

FR (1)