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Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform (NAVISTROKE)

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ClinicalTrials.gov Identifier: NCT03956160
Recruitment Status : Not yet recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Due to the brutality of stroke and increasingly shorter lengths of hospital stay, patients and their families must adapt quickly to the patient's new state of health and the new role of caregiver for family members. Patients and caregivers report a significant need for advice and information during this transition period. Thus, the provision of information through an Internet platform could meet these characteristics, in association with individualised support by a case-manager to ensure continuity of care and improve care pathway.

The investigating team's hypothesis is that, through comprehensive, individualized and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition program, combining an Internet platform and telephone follow-up by a case-manager, could improve patients' level of participation and quality of life.


Condition or disease Intervention/treatment Phase
Stroke Other: A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation. Not Applicable

Detailed Description:

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 lengths of hospital stay, patients and their families must adapt quickly to the patient's new state of health and the new role of caregiver for family members. Currently, 70% of patients return home directly after treatment in a stroke center. Following the acute phase, the patient's care path involves many health and social workers. However, the health care system is complex and difficult for patients and their caregivers to understand. A lack of support during the hospital/home transition has significant negative consequences for the patient (reduced functional prognosis, quality of life and reintegration, increased risk of recurrence) and his or her caregiver (increased perceived burden, decreased quality of life, socio-economic impact).

Patients and caregivers report a significant need for advice and information during this transition period. They are looking for individualized, good quality information and whose nature evolves over time with the needs and recovery of the patient. Thus, the provision of information through an Internet platform could meet these characteristics, in association with individualised support by a case-manager to ensure continuity of care and improve care pathway. In France, no such program has been developed to date for stroke. Existing transition programmes mainly focus on home rehabilitation and do not offer a comprehensive approach to the situation, integrating caregivers. In addition, no programs have been developed in partnership with patients and families to best meet their needs.

The investigator's hypothesis is that, through comprehensive, individualized and flexible support for patients and their caregivers, a patient-centred post-stroke hospital/home transition program, combining an Internet platform and telephone follow-up by a case-manager, could improve patients' level of participation and quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: Intervention group

For 12 months from the return home, patients in the intervention group will benefit from telephone support by a trained case-manager (number and frequency of contacts defined according to the patient's needs) and access to an Internet platform.

The intervention aims to improve the patient's ability to manage his or her situation and meet his or her needs upon return home, including identifying and requesting the necessary health or social resources.

Other: A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.

4 participatory co-design workshops lasting 4 hours each that will follow a "user-centered design" approach: identification of end-user needs, prototyping/development of the intervention (case-management procedures and platform), iterative improvement, end-user testing.

Based on the cognitive social theory underpinning the intervention, scientific literature, an overview of existing organizations and the results of the Stroke 69 and Arthur Tybra studies (patient needs following the acute phase), the advisory committee will:

  • Define the case-manager's profile, and required knowledge and skills
  • Identify the resources and tools to be proposed on the Internet platform
  • Test the tools and content
  • Refine the program evaluation criteria
  • Test and validate the study procedures.

No Intervention: Control group

Patients randomized to the control group will receive the usual practices. As part of the study, they will be contacted for data collection upon their return home, at 6 months and 12 months by a clinical research associate.

Access to the internet platform and an interview with the case-manager will be offered at the end of the study to patients in the control group.




Primary Outcome Measures :
  1. Participation at 6 months after hospital discharge [ Time Frame: 6 months ]
    Patient participation score, measured by the score obtained in the "participation" dimension of the stroke-specific quality of life scale: Stroke Impact Scale 6 months after discharge from hospital


Secondary Outcome Measures :
  1. Participation at 12 months after hospital discharge [ Time Frame: 12 months ]
    Evolution of the patient participation score between discharge and 12 months after discharge

  2. Quality of life at discharge from hospital [ Time Frame: 1 day ]
    Evolution of the other dimensions of the Stroke Impact Scale (SIS) at hospital discharge: force dimension, manual function, daily activities, mobility, communication, emotions, memory/thinking and global recovery.

  3. Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS) [ Time Frame: 6 months ]
    Evolution of the other dimensions of the Stroke Impact Scale (SIS) at 6 months: force dimension, manual function, daily activities, mobility, communication, emotions, memory/thinking and global recovery.

  4. Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS) [ Time Frame: 12 months ]
    Evolution of the other dimensions of the Stroke Impact Scale (SIS) at 12 months: force dimension, manual function, daily activities, mobility, communication, emotions, memory/thinking and global recovery.

  5. Anxiety and depression scores at discharge from hospital [ Time Frame: 1 day ]
    Evolution of anxiety and depression scores at discharge measured by the Hospital Anxiety and Depression scale (HADS) score.

  6. Anxiety and depression scores at 6 months after hospital discharge [ Time Frame: 6 months ]
    Evolution of anxiety and depression scores at 6 months measured by the Hospital Anxiety and Depression scale (HADS) score.

  7. Anxiety and depression scores at 12 months after hospital discharge [ Time Frame: 12 months ]
    Evolution of anxiety and depression scores at 12 months measured by the Hospital Anxiety and Depression scale (HADS) score.

  8. Fatigue at discharge from hospital [ Time Frame: 1 day ]
    Changes in fatigue level measured by the Pichot scale

  9. Fatigue at 6 months after hospital discharge [ Time Frame: 6 months ]
    Changes in fatigue level measured by the Pichot scale

  10. Fatigue at 12 months after hospital discharge [ Time Frame: 12 months ]
    Changes in fatigue level measured by the Pichot scale

  11. Sleep quality: Pittsburgh scale [ Time Frame: 1 day ]
    Sleep quality measured by the Pittsburgh scale

  12. Sleep quality at 6 months after hospital discharge: Pittsburgh scale [ Time Frame: 6 months ]
    Sleep quality measured by the Pittsburgh scale

  13. Sleep quality at 12 months after hospital discharge: Pittsburgh scale [ Time Frame: 12 months ]
    Sleep quality measured by the Pittsburgh scale

  14. Sleepiness [ Time Frame: 1 day ]
    Sleepiness level measured by the Epworth scale

  15. Sleepiness at 6 months after hospital discharge [ Time Frame: 6 months ]
    Sleepiness level measured by the Epworth scale

  16. Sleepiness at 12 months after hospital discharge [ Time Frame: 12 months ]
    Sleepiness level measured by the Epworth scale

  17. Prognosis at 12 months after hospital discharge (Stroke recurrence) [ Time Frame: 12 months ]
    Stroke recurrence within 12 months, reported by the patient and/or caregiver and validated by checking the hospitalization report.

  18. Prognosis at 12 months after hospital discharge (hospitalizations) [ Time Frame: 12 months ]
    Unscheduled hospitalizations or emergency room visits within 12 months of discharge from hospital.

  19. Prognosis at 12 months after hospital discharge (neurologic disability) [ Time Frame: 12 months ]
    Modified Rankin Score at 12-month

  20. Prognosis at 12 months after hospital discharge (death) [ Time Frame: 12 months ]
    Death at 12 months

  21. Cognitive disorders at hospital discharge [ Time Frame: 1 day ]
    Cognitive disorders at discharge from hospital measured by the Montreal Cognitive Assessment (MOCA) scale

  22. Cognitive disorders at 12 months after hospital discharge [ Time Frame: 12 months ]
    Cognitive disorders at 12 months measured by the Montreal Cognitive Assessment (MOCA) scale

  23. Access to care at 12 months after hospital discharge [ Time Frame: 12 months ]
    Consumption of care (consultations and hospitalizations) collected from the regional health insurance database

  24. Access to social services at 12 months after hospital discharge [ Time Frame: 12 months ]
    Requests for social support made

  25. Maintaining hospital discharge prescriptions at 6 months after hospital discharge [ Time Frame: 6 months ]
    Therapeutic persistence: maintenance of therapeutic prescriptions for discharge from hospital at 6 months. The prescriptions for secondary preventive treatment of stroke will be considered. Data will be collected by interviewing the patient.

  26. Maintaining hospital discharge prescriptions at 12 months after hospital discharge [ Time Frame: 12 months ]
    Therapeutic persistence: maintenance of therapeutic prescriptions for discharge from hospital at 12 months. The prescriptions for secondary preventive treatment of stroke will be considered. Data will be collected by interviewing the patient.

  27. Occupational status at 12 months after hospital discharge [ Time Frame: 12 months ]
    Occupational status at 12 months: return to work will be defined by working at least one day per week. Among these patients, resumption of the same professional activity, professional reclassification or adapted working time, early retirement.

  28. Social isolation at discharge from hospital [ Time Frame: 1 day ]
    Social isolation at discharge from hospital measured by the Social Support score Questionnaire 6

  29. Social isolation at 6 months after hospital discharge [ Time Frame: 6 months ]
    Social isolation at 6 months after discharge from hospital measured by the Social Support score

  30. Social isolation at 12 months after hospital discharge [ Time Frame: 12 months ]
    Social isolation at 12 months after discharge from hospital measured by the Social Support score

  31. Patient activation level at discharge from hospital [ Time Frame: 1 day ]
    Patient activation will be measured by the score obtained at the "Patient activation Measure" scale. This questionnaire is composed of 22 items that assess the patient's knowledge, skills and confidence level to manage their own situation (self-management).

  32. Patient activation level at 6 months after hospital discharge [ Time Frame: 6 months ]
    Patient activation will be measured by the score obtained at the "Patient activation Measure" scale. This questionnaire is composed of 22 items that assess the patient's knowledge, skills and confidence level to manage their own situation (self-management).

  33. Patient activation level at 12 months after hospital discharge [ Time Frame: 12 months ]
    Patient activation will be measured by the score obtained at the "Patient activation Measure" scale. This questionnaire is composed of 22 items that assess the patient's knowledge, skills and confidence level to manage their own situation (self-management).

  34. Maintenance at home at 12 months after hospital discharge [ Time Frame: 12 months ]
    Data concerning the patient's place of residence 12 months after hospital discharge will be collected by interviewing the patient

  35. Satisfaction with the support received upon return home: ad-hoc questionnaire [ Time Frame: 12 months ]
    Satisfaction with the support received upon return home, measured at 12 months by an ad-hoc questionnaire

  36. Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire [ Time Frame: 6 months ]
    Feeling of information about stroke and medical and social care at 6 months through an ad-hoc questionnaire

  37. Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire [ Time Frame: 12 months ]
    Feeling of information about stroke and medical and social care at 12 months through an ad-hoc questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient,
  • Having had a first confirmed, ischemic or hemorrhagic stroke
  • Managed in the participating stroke center
  • Whose return home directly from the stroke 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 of France
  • Aphasic patients may be included if a caregiver can follow up with the case manager

Exclusion Criteria:

  • Patient residing in an institution prior to stroke
  • Supported in the gerontological field before stroke
  • Inability to communicate by telephone with the case-manager and absence of a caregiver to follow up by telephone with the case-manager

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956160


Contacts
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Contact: Julie Haesebaert, Dr 4 72 68 49 05 ext 33 julie.haesebaert01@chu-lyon.fr
Contact: Anne Termoz 4 27 85 63 00 ext 33 anne.termoz@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Julie Haesebaert, Dr Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03956160    
Other Study ID Numbers: 69HCL19_0042
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Caregiver
Support
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases