StrokePARADENCT04197258
Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study
A study testing Peer support in people with Stroke, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Peer support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2020to 5 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
Gilles RODE, Pr, 4 78 86 50 66 ext. +33, gilles.rode@chu-lyon.fr
About this study
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
- Being tested
- Peer support
- Keywords
- Stroke, Peer support
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Patient activation Measure
Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score
Measured: 6 months
Disability
proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs<3)
Measured: 6 months
Adherence
proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)
Measured: 6 months
Human, material and financial assistance provided at home
Human, material and financial assistance provided at home collected by interviewing the patient
Measured: 6 months
Satisfaction measure
Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient
Measured: 6 months
Caregiver burden
Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale
Measured: 6 months
Caregiver satisfaction
Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start9 Oct 2020
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197258
- Sponsor's protocol ID
- 69HCL19_0233
- Acronym
- PARADE
- Status last verified
- May 2025
- First submitted
- 5 Dec 2019
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study
- ClinicalTrials.gov ID
- NCT04197258
- Acronym / sponsor ID
- PARADE / 69HCL19_0233
- Conditions
- Stroke
- Keywords
- Stroke, Peer support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Peer supportFor 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer supportThe 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. | Other | intervention group |
Primary outcome
Feasibility measure
Time frame: 6 months
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.
15 secondary outcomes
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Quality of life between the discharge from hospital and 6 months
Time frame: 6 months
Anxiety and depression scores between discharge and 6 months
Time frame: 6 months
Patient activation Measure
Time frame: 6 months
Disability
Time frame: 6 months
Adherence
Time frame: 6 months
Human, material and financial assistance provided at home
Time frame: 6 months
Satisfaction measure
Time frame: 6 months
Caregiver burden
Time frame: 6 months
Caregiver satisfaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support in people with Stroke, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Haesebaert, MD (472684905 ext. +33, julie.haesebaert01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.