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Recruiting NCT04197258

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer support.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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-

Primary outcome measures

  • Feasibility measure [Time frame: 6 months]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Hôpital Henry Gabrielle — Saint-Genis-Laval

Identifiers

NCT: NCT04197258 · 69HCL19_0233

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗