StrokeNAVISTROKENCT03956160
Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform
A study testing A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation. in people with Stroke, run by Hospices Civils de Lyon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.
- Keywords
- Caregiver, Support
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation. |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation at 6 months after hospital discharge
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
Measured: 6 months
Secondary outcomes (32)
Participation at 12 months
Participation score at 12 months after discharged home
Measured: 12 months
Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS)
Score 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.
Measured: 6 months
Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS)
Score 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.
Measured: 12 months
Anxiety and depression scores at 6 months after hospital discharge
Change of anxiety and depression scores between discharge home and 6 months measured by the Hospital Anxiety and Depression scale (HADS) score.
Measured: 6 months
Anxiety and depression scores at 12 months after hospital discharge
Change of anxiety and depression scores between discharge home and 12 months measured by the Hospital Anxiety and Depression scale (HADS) score.
Measured: 12 months
Fatigue at 6 months after hospital discharge
Changes in fatigue level measured by the Pichot scale between discharge home and 6 months
Measured: 6 months
Fatigue at 12 months after hospital discharge
Changes in fatigue level measured by the Pichot scale between discharge home and 12 months
Measured: 12 months
Sleep quality at 6 months after hospital discharge: Pittsburgh scale
Sleep quality measured by the Pittsburgh scale between discharge home and 6 months
Measured: 6 months
Sleep quality at 12 months after hospital discharge: Pittsburgh scale
Sleep quality measured by the Pittsburgh scale between discharge home and 12 months
Measured: 12 months
Sleepiness at 6 months after hospital discharge
Sleepiness level measured by the Epworth scale between discharge home and 6 months
Measured: 6 months
Sleepiness at 12 months after hospital discharge
Sleepiness level measured by the Epworth scale between discharge home and 12 months
Measured: 12 months
Prognosis at 12 months after hospital discharge (Stroke recurrence)
Stroke recurrence within 12 months, reported by the patient and/or caregiver and validated by checking the hospitalization report.
Measured: 12 months
Prognosis at 12 months after hospital discharge (hospitalizations)
Unscheduled hospitalizations or emergency room visits within 12 months of discharge from hospital.
Measured: 12 months
Prognosis at 12 months after hospital discharge (neurologic disability)
Modified Rankin Score at 12-month
Measured: 12 months
Prognosis at 12 months after hospital discharge (death)
Death at 12 months
Measured: 12 months
Cognitive disorders at hospital discharge
Cognitive disorders at discharge from hospital measured by the Montreal Cognitive Assessment (MOCA) scale
Measured: 1 day
Cognitive disorders at 12 months after hospital discharge
Cognitive disorders at 12 months measured by the Montreal Cognitive Assessment (MOCA) scale
Measured: 12 months
Access to care at 12 months after hospital discharge
Consumption of care (consultations and hospitalizations) collected from the regional health insurance database
Measured: 12 months
Access to social services at 12 months after hospital discharge
Requests for social support made
Measured: 12 months
Maintaining hospital discharge prescriptions at 6 months after hospital discharge
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.
Measured: 6 months
Maintaining hospital discharge prescriptions at 12 months after hospital discharge
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.
Measured: 12 months
Occupational status at 12 months after hospital discharge
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.
Measured: 12 months
Social isolation at discharge from hospital
Social isolation at discharge from hospital measured by the Social Support score Questionnaire 6
Measured: 1 day
Social isolation at 6 months after hospital discharge
Social isolation at 6 months after discharge from hospital measured by the Social Support score
Measured: 6 months
Social isolation at 12 months after hospital discharge
Social isolation at 12 months after discharge from hospital measured by the Social Support score
Measured: 12 months
Patient activation level at discharge from hospital
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).
Measured: 1 day
Patient activation level at 6 months after hospital discharge
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).
Measured: 6 months
Patient activation level at 12 months after hospital discharge
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).
Measured: 12 months
Maintenance at home at 12 months after hospital discharge
Data concerning the patient's place of residence 12 months after hospital discharge will be collected by interviewing the patient
Measured: 12 months
Satisfaction with the support received upon return home: ad-hoc questionnaire
Satisfaction with the support received upon return home, measured at 12 months by an ad-hoc questionnaire
Measured: 12 months
Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire
Feeling of information about stroke and medical and social care at 6 months through an ad-hoc questionnaire
Measured: 6 months
Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire
Feeling of information about stroke and medical and social care at 12 months through an ad-hoc questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start30 Dec 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Haesebaert, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956160
- Sponsor's protocol ID
- 69HCL19_0042
- Acronym
- NAVISTROKE
- Status last verified
- Sep 2021
- First submitted
- 15 May 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) may be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Publications
Termoz A, Delvallee M, Damiolini E, Marchal M, Preau M, Huchon L, Mazza S, Habchi O, Bravant E, Derex L, Nighoghossian N, Cakmak S, Rabilloud M, Denis A, Schott AM, Haesebaert J. Co-design and evaluation of a patient-centred transition programme for stroke patients, combining case management and access to an internet information platform: study protocol for a randomized controlled trial - NAVISTROKE. BMC Health Serv Res. 2022 Apr 22;22(1):537. doi: 10.1186/s12913-022-07907-5.
PubMed 35459183
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform
- ClinicalTrials.gov ID
- NCT03956160
- Acronym / sponsor ID
- NAVISTROKE / 69HCL19_0042
- Conditions
- Stroke
- Keywords
- Caregiver, Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 20 May 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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.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. |
| Control group | No intervention | –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. |
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 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 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. | Other | Intervention group |
Primary outcome
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
32 secondary outcomes
Participation at 12 months
Time frame: 12 months
Quality of life at 6 months after hospital discharge: Stroke Impact Scale (SIS)
Time frame: 6 months
Quality of life at 12 months after hospital discharge: Stroke Impact Scale (SIS)
Time frame: 12 months
Anxiety and depression scores at 6 months after hospital discharge
Time frame: 6 months
Anxiety and depression scores at 12 months after hospital discharge
Time frame: 12 months
Fatigue at 6 months after hospital discharge
Time frame: 6 months
Fatigue at 12 months after hospital discharge
Time frame: 12 months
Sleep quality at 6 months after hospital discharge: Pittsburgh scale
Time frame: 6 months
Sleep quality at 12 months after hospital discharge: Pittsburgh scale
Time frame: 12 months
Sleepiness at 6 months after hospital discharge
Time frame: 6 months
Sleepiness at 12 months after hospital discharge
Time frame: 12 months
Prognosis at 12 months after hospital discharge (Stroke recurrence)
Time frame: 12 months
Prognosis at 12 months after hospital discharge (hospitalizations)
Time frame: 12 months
Prognosis at 12 months after hospital discharge (neurologic disability)
Time frame: 12 months
Prognosis at 12 months after hospital discharge (death)
Time frame: 12 months
Cognitive disorders at hospital discharge
Time frame: 1 day
Cognitive disorders at 12 months after hospital discharge
Time frame: 12 months
Access to care at 12 months after hospital discharge
Time frame: 12 months
Access to social services at 12 months after hospital discharge
Time frame: 12 months
Maintaining hospital discharge prescriptions at 6 months after hospital discharge
Time frame: 6 months
Maintaining hospital discharge prescriptions at 12 months after hospital discharge
Time frame: 12 months
Occupational status at 12 months after hospital discharge
Time frame: 12 months
Social isolation at discharge from hospital
Time frame: 1 day
Social isolation at 6 months after hospital discharge
Time frame: 6 months
Social isolation at 12 months after hospital discharge
Time frame: 12 months
Patient activation level at discharge from hospital
Time frame: 1 day
Patient activation level at 6 months after hospital discharge
Time frame: 6 months
Patient activation level at 12 months after hospital discharge
Time frame: 12 months
Maintenance at home at 12 months after hospital discharge
Time frame: 12 months
Satisfaction with the support received upon return home: ad-hoc questionnaire
Time frame: 12 months
Feeling towards information at 6 months after hospital discharge: ad-hoc questionnaire
Time frame: 6 months
Feeling towards information at 12 months after hospital discharge: ad-hoc questionnaire
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 35459183Termoz A, Delvallee M, Damiolini E, Marchal M, Preau M, Huchon L, Mazza S, Habchi O, Bravant E, Derex L, Nighoghossian N, Cakmak S, Rabilloud M, Denis A, Schott AM, Haesebaert J. Co-design and evaluation of a patient-centred transition programme for stroke patients, combining case management and access to an internet information platform: study protocol for a randomized controlled trial - NAVISTROKE. BMC Health Serv Res. 2022 Apr 22;22(1):537. doi: 10.1186/s12913-022-07907-5.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) may be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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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. This study is not recruiting at the moment.
Julie Haesebaert, Dr principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
A study testing A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation. in people with Stroke, run by Hospices Civils de Lyon.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Haesebaert, Dr (4 72 68 49 05 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?
Participation at 6 months after hospital discharge (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956160, which also lists 1 linked publication.
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 17 Sep 2021.