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

Stroke Clinical Trial

— PARADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197258
• Other study ID #: 69HCL19_0233
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: February 5, 2025

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Julie Haesebaert, MD
• Phone: 472684905
• Email: julie.haesebaert01[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 5, 2025
• Est. primary completion date: February 5, 2025
• 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 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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Henry Gabrielle	Saint-Genis-Laval

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient activation Measure	Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score	6 months
Secondary	Disability	proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs<3)	6 months
Secondary	Adherence	proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)	6 months
Secondary	Human, material and financial assistance provided at home	Human, material and financial assistance provided at home collected by interviewing the patient	6 months
Secondary	Satisfaction measure	Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient	6 months
Secondary	Caregiver burden	Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale	6 months
Secondary	Caregiver satisfaction	Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver	6 months