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NCT Number: NCT04197258

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location status: Recruiting

Location contact

Gilles RODE, Pr

CONTACT

[email protected]

4 78 86 50 66 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Support

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: force dimension

  2. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: manual function

  3. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: AVQ/AVD

  4. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: Mobility

  5. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: Communication and Emotions

  6. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: Memory and thinking

  7. Quality of life between the discharge from hospital and 6 months

    Time frame: 6 months

    Evolution of the dimensions of the SIS at hospital discharge and 6 months: global recovery

  8. Anxiety and depression scores between discharge and 6 months

    Time frame: 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

  9. Patient activation Measure

    Time frame: 6 months

    Evolution of patient activation between discharge and 6 months after discharge, measured by the Patient activation Measure (PAM) score

  10. Disability

    Time frame: 6 months

    proportion of patients with disabilities at 6 months evaluated by the Modified Rankin Scale (no disability corresponding to mRs<3)

  11. Adherence

    Time frame: 6 months

    proportion of adherent patients at 6 months evaluated by the Medication Adherence Rating Scale (MARS)

  12. Human, material and financial assistance provided at home

    Time frame: 6 months

    Human, material and financial assistance provided at home collected by interviewing the patient

  13. Satisfaction measure

    Time frame: 6 months

    Perceived satisfaction of the support received on during the discharge period will be collected by interviewing the patient

  14. Caregiver burden

    Time frame: 6 months

    Evolution of caregiver burden between discharge and 6 months after discharge, measured by the Zarit burden scale

  15. Caregiver satisfaction

    Time frame: 6 months

    Perceived caregiver satisfaction of the support during the patient's discharge period will be collected by interviewing caregiver

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Termoz

CONTACT

[email protected]

427856300 ext. +33

Julie Haesebaert, MD

CONTACT

[email protected]

472684905 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PARADE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2019
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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