Back to resultsEvaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study (PARADE)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Peer support
Sponsored by
About this trial
This is an interventional health services research trial for Stroke focused on measuring Stroke, Peer support
Eligibility Criteria
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
Sites / Locations
- Hôpital Henry GabrielleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
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
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
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
Patient activation Measure
Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score
Disability
proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs<3)
Adherence
proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)
Human, material and financial assistance provided at home
Human, material and financial assistance provided at home collected by interviewing the patient
Satisfaction measure
Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient
Caregiver burden
Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale
Caregiver satisfaction
Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver
Full Information
NCT ID
NCT04197258
First Posted
December 5, 2019
Last Updated
February 13, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT04197258
Brief Title
Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study
Acronym
PARADE
Official Title
Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
February 5, 2025 (Anticipated)
Study Completion Date
February 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Peer support
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Peer support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility measure
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: force dimension
Time Frame
6 months
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: manual function
Time Frame
6 months
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: AVQ/AVD
Time Frame
6 months
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: Mobility
Time Frame
6 months
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: Communication and Emotions
Time Frame
6 months
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: Memory and thinking
Time Frame
6 months
Title
Quality of life between the discharge from hospital and 6 months
Description
Evolution of the dimensions of the SIS at hospital discharge and 6 months: global recovery
Time Frame
6 months
Title
Anxiety and depression scores between discharge and 6 months
Description
Evolution of anxiety and depression scores between discharge and 6 months after discharge, measured by the Hospital Anxiety and Depression scale (HADS) score
Time Frame
6 months
Title
Patient activation Measure
Description
Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score
Time Frame
6 months
Title
Disability
Description
proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs<3)
Time Frame
6 months
Title
Adherence
Description
proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)
Time Frame
6 months
Title
Human, material and financial assistance provided at home
Description
Human, material and financial assistance provided at home collected by interviewing the patient
Time Frame
6 months
Title
Satisfaction measure
Description
Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient
Time Frame
6 months
Title
Caregiver burden
Description
Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale
Time Frame
6 months
Title
Caregiver satisfaction
Description
Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Haesebaert, MD
Phone
472684905
Ext
+33
Email
julie.haesebaert01@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Termoz
Phone
427856300
Ext
+33
Email
anne.termoz@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles RODE, Pr
Phone
4 78 86 50 66
Ext
+33
Email
gilles.rode@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study
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