Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04197258
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility measure', 'timeFrame': '6 months', 'description': 'The feasibility of the intervention will be evaluated as success with a combined criteria including:\n\n* Recruitment and training of 2 peer helpers,\n* 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,\n* 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.'}], 'secondaryOutcomes': [{'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: force dimension'}, {'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: manual function'}, {'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: AVQ/AVD'}, {'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: Mobility'}, {'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: Communication and Emotions'}, {'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: Memory and thinking'}, {'measure': 'Quality of life between the discharge from hospital and 6 months', 'timeFrame': '6 months', 'description': 'Evolution of the dimensions of the SIS at hospital discharge and 6 months: global recovery'}, {'measure': 'Anxiety and depression scores between discharge and 6 months', 'timeFrame': '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'}, {'measure': 'Patient activation Measure', 'timeFrame': '6 months', 'description': 'Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score'}, {'measure': 'Disability', 'timeFrame': '6 months', 'description': 'proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs\\<3)'}, {'measure': 'Adherence', 'timeFrame': '6 months', 'description': 'proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)'}, {'measure': 'Human, material and financial assistance provided at home', 'timeFrame': '6 months', 'description': 'Human, material and financial assistance provided at home collected by interviewing the patient'}, {'measure': 'Satisfaction measure', 'timeFrame': '6 months', 'description': 'Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient'}, {'measure': 'Caregiver burden', 'timeFrame': '6 months', 'description': 'Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale'}, {'measure': 'Caregiver satisfaction', 'timeFrame': '6 months', 'description': "Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Peer support'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "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.\n\nPeer 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient,\n* Having had a first confirmed, ischemic or hemorrhagic stroke\n* Managed in the participating rehabilitation center\n* Whose discharge to home directly from the rehabilitation center is planned\n* Presenting a modified Rankin score of 1 to 3 when deciding to leave the stroke center\n* Having given its written consent\n* Whose main residence is located in the Rhône department\n* Aphasic patients may be included if a caregiver can follow up with the case manager\n\nExclusion Criteria:\n\n* Patient living in an institution prior to stroke\n* included in a gerontological network before stroke\n* Patient unable to understand quality of life questionnaires\n* 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\n* Patient under guardianship or curatorship\n* Patient not affiliated to a social health insurance'}, 'identificationModule': {'nctId': 'NCT04197258', 'acronym': 'PARADE', 'briefTitle': 'Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the Impact of an Individual Peer Support Intervention for Stroke Patients When Returning Home: a Mixed Methods Pilot Study', 'orgStudyIdInfo': {'id': '69HCL19_0233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', '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).\n\nThe 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", 'interventionNames': ['Other: Peer support']}, {'type': 'NO_INTERVENTION', 'label': 'control group', '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.'}], 'interventions': [{'name': 'Peer support', 'type': 'OTHER', '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.\n\nPeer 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.", 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69230', 'city': 'Saint-Genis-Laval', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles RODE, Pr', 'role': 'CONTACT', 'email': 'gilles.rode@chu-lyon.fr', 'phone': '4 78 86 50 66', 'phoneExt': '+33'}], 'facility': 'Hôpital Henry Gabrielle', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}], 'centralContacts': [{'name': 'Julie Haesebaert, MD', 'role': 'CONTACT', 'email': 'julie.haesebaert01@chu-lyon.fr', 'phone': '472684905', 'phoneExt': '+33'}, {'name': 'Anne Termoz', 'role': 'CONTACT', 'email': 'anne.termoz@chu-lyon.fr', 'phone': '427856300', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}