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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Peer support

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Haesebaert, MD; Phone Number: +33 472684905; Email: julie.haesebaert01@chu-lyon.fr
• Study Contact Backup: Name: Anne Termoz; Phone Number: +33 427856300; Email: anne.termoz@chu-lyon.fr

Study Locations

• France
  • Saint-Genis-Laval, France, 69230
    • Recruiting
    • Hôpital Henry Gabrielle
    • Contact: Gilles RODE, Pr; Phone Number: +33 4 78 86 50 66; Email: gilles.rode@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; 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; 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.
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: force dimension	6 months
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: manual function	6 months
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: AVQ/AVD	6 months
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: Mobility	6 months
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: Communication and Emotions	6 months
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: Memory and thinking	6 months
Quality of life between the discharge from hospital and 6 months	Evolution of the dimensions of the SIS at hospital discharge and 6 months: global recovery	6 months
Anxiety and depression scores between discharge and 6 months	Evolution of anxiety and depression scores between discharge and 6 months after discharge, measured by the Hospital Anxiety and Depression scale (HADS) score	6 months
Patient activation Measure	Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score	6 months
Disability	proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs<3)	6 months
Adherence	proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)	6 months
Human, material and financial assistance provided at home	Human, material and financial assistance provided at home collected by interviewing the patient	6 months
Satisfaction measure	Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient	6 months
Caregiver burden	Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale	6 months
Caregiver satisfaction	Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver	6 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Peer support
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 69HCL19_0233

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No