StrokeP-NAVISTROKENCT05928832
Evaluation of the Feasibility of a Patient-centered Transition Program for Stroke Patients and Their Informal Caregivers, Combining Follow-up by a Case-manager and Access to an Internet Information Platform
A study testing Follow-up by a case-manager and access to the internet platform in people with Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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 families must adapt quickly to the patient's new state of health and the new role of informal 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?
- Follow-up by a case-manager and access to the internet platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 Aug 2024
- 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
- For patients:
- Adult patient,
- Having had a first confirmed, ischemic or hemorrhagic stroke
- Hospitalized in a participating stroke center,
- Living at home before the stroke,
- Whose return home directly from the stroke center is planned
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- Presenting a modified Rankin score of 1 to 3 when deciding to leave the stroke center (absence of significant disability with moderate disability)
- Having given its written consent
- Whose main residence is located in the Rhône department
- Aphasic patients, who have disorders that limit their ability to communicate by phone with the case-manager will be included in the event of identification of an informal caregiver with telephone support.
- Aphasic patients may be included if an informal caregiver can follow up with the case manager
- For informal caregivers:
- Adult patient
- Being a caregiver of a patient agreeing to participate in the NAVISTROKE study,
- Having given their written consent
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
- Pregnant or breastfeeding women,
- Persons deprived of their liberty by a judicial or administrative decision,
- Persons under psychiatric care
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- Persons admitted to a health or social establishment for purposes other than research,
- Persons of full age subject to a legal protection measure (guardians, curators),
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme,
- Subjects participating in other intervention research with an exclusion period still in progress at inclusion
- Patients who do not understand French
Trial locations and contacts
1 site in 1 country.
France1 site
Unité Neuro-Vasculaire des Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, 69677
Laurent MD DEREX, 0472357809 ext. +33, laurent.derex@chu-lyon.fr
About this 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 lengths of hospital stay, patients and families must adapt quickly to the patient's new state of health and the new role of informal 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 informal 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 informal caregiver (increased perceived burden, decreased quality of life, socio-economic impact).
Patients and informal 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 individualized 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 programs 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 needs.
Read more
An hospital-to-home transition support program in partnership with patients and relatives using a "user-centered design" approach has been developed in order to best meet needs.
A first phase of co-construction has been conducted while 4 participatory workshops for (patients, informal caregivers, healthcare assistants and professionals in the social field) were carried out to precisely define and develop the program. The program was developed in based on data from the scientific literature, an inventory of existing systems and the experience of participants. During this phase a usability testing of the platform developed during the workshops with patients and informal caregivers following a Think Aloud method has also been conducted.
The hypothesis is that the implementation of this patient-centered post-stroke hospital/home transition program, combining an Internet platform and follow-up by a case-manager, is feasible within stroke center and will receive good acceptability from healthcare professionals, patients and informal caregivers.
- Conditions
- Stroke
- Being tested
- Follow-up by a case-manager and access to the internet platform
- Keywords
- Stroke, Participation, Case-manager, Internet information platform
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up by a case-manager and access to the internet platformOther
Patients in the intervention group receive an information letter on their discharge presenting the follow-up from which they benefit:call from the case-manager and access to the internet platform. The case-manager meets the patient and/or informal caregiver on the day of discharge from hospital. He recontacts the patient and/or informal caregiver within 7 days after returning home. A follow-up is offered to patients and caregivers following their return home, according to the objectives defined during the initial interview. The total duration of the support is 6 months maximum including at least 4 contacts with the case-manager,but this is refined and adapted with the patient, according to needs. Similarly, the frequency and methods (face-to-face or remote) of contact varies according to the needs of the patients and the stage of support, and is defined by the case-manager and patient. Patients and/or informal caregivers is also able to contact the case-manager 'on request'.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention group will receive an information letter on their discharge presenting the follow-up from which they will benefit: call from the case-manager and access to the internet platform. Receives: Other: Follow-up by a case-manager and access to the internet platform |
| Control group | No intervention | Patients randomized to the control group will receive the usual practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing the Navistroke program
Conclusion on the feasibility if the composite criteria is positive, namely:
- Inclusion of 30 patients over a period of 4 months.
- Realization of at least two exchanges out of the four defined in the follow-up with the case-manager for the 15 patients included in the intervention group.
- Maintenance of the intervention during the 6-months study period
Measured: 6 months
Secondary outcomes (12)
Patients - Quality of life of patients
Measured by the score of the Stroke Impact Scale (SIS) 6 months after discharged home.
This is a specific quality of life scale for patients post-stroke. The scale contains 64 items measuring 8 different domains (strength, hand functionality, Activities of Daily Living ADL/ Instrumental Activities of Daily Living IADL, mobility, communication, emotion, memory/thinking and social participation) and one item assessing overall recovery out of 100. The items are scored using a Likert scale with 5 response options. The score is reported out of 100 for each dimension (100 = no difficulties, 0= maximum difficulties)
Measured: 6 months
Patients - Participation score of patients
Measured by the score obtained in the "participation" dimension of the SIS, 6 months after discharged home.
Measured: 6 months
Patients - Anxiety and depression scores between discharge and 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.
HADS is a specific depression and anxiety scale of 14 items. The scale contains 14 items of which 7 measure anxiety and 7 measure depression. The items are scored from 0 to 3, giving two scores out of 21 for each dimension; a score above 11 indicates an anxious or depressed state.
Measured: 6 months
Patients - Fatigue between discharge and 6 months
Changes in fatigue level measured by the Pichot scale between discharge and 6 months.
Pichot scale is a specific fatigue scale of 8 items. The items are scored from 0 to 4. A score above 22 indicates an excessive fatigue.
Measured: 6 months
Patients - Social isolation between discharge and 6 month
Social isolation at discharge and 6 months measured by the Social Support score Questionnaire 6.
Individuals are required to respond to the 6 items by (a) indicating the number of individuals available to support them and (b) rating their level of satisfaction with social support. Scores can range from 0 (no social support) to 6 (very high social support) for the number of available supports, and from 1 (very unsatisfied) to 6 (very satisfied) for the satisfaction domain in each item or area. From these scores in the 6 areas, an average score is calculated for the number of available supports and for satisfaction.
Measured: 6 months
Patients - Satisfaction
Satisfaction with the support received upon return home, measured at 6 months by an ad-hoc questionnaire of 11 items.
Measured: 6 months
Patients - Information feeling
Satisfaction with the information received about the pathology, the medical and social care upon return home, measured at 6 months by an ad-hoc questionnaire of 11 items.
Measured: 6 months
Informal caregivers - Evolution of the quality of life between the patient's discharge from hospital and 6 months
Measured by the Short Form-12 (SF-12) questionnaire between discharge and 6 months.
This is a validated scale measuring health-related quality of life. Score is between 0 and 100, A higher score is associated to a better outcome.
Measured: 6 months
Informal caregivers - Level of perceived burden
Measured by the ZARIT burden of care scale (Zarit Burden scale) This is a self questionnaire assessing the suffering of caregivers. Score is between 0 and 88. A higher score is associated to a worse outcome.
Measured: 6 months
Informal caregivers - Evolution of the global anxiety-depression score between discharge and 6 months after the patient's discharge from hospital
Evolution of anxiety and depression scores between discharge and 6 months after discharge, measured by the Hospital Anxiety and Depression scale (HADS) score.
HADS is a specific depression and anxiety scale of 14 items. The scale contains 14 items of which 7 measure anxiety and 7 measure depression. The items are scored from 0 to 3, giving two scores out of 21 for each dimension; a score above 11 indicates an anxious or depressed state.
Measured: 6 months
Informal caregivers - Satisfaction with the support and information received when returning home
Satisfaction with the support received upon return home, measured at 6 months by an ad-hoc questionnaire of 11 items.
Measured: 6 months
Informal caregivers - Information feeling
Satisfaction with the information received about the pathology, the medical and social care upon return home, measured at 6 months by an ad-hoc questionnaire of 11 items.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928832
- Sponsor's protocol ID
- 69HCL23_0237
- Acronym
- P-NAVISTROKE
- Status last verified
- Aug 2023
- First submitted
- 23 Jun 2023
- Last updated
- 14 Aug 2023
- 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
Delvallee M, Blazer A, Marchal M, Termoz A, Habchi O, Schott AM, Derex L, Haesebaert J. Feasibility and acceptability of a randomized controlled trial of a patient-centred transition program for stroke survivors and their caregivers-P-NAVISTROKE study. Disabil Rehabil. 2026 Aug 20:1-16. doi: 10.1080/09638288.2026.2719948. Online ahead of print.
PubMed 42621673
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of a Patient-centered Transition Program for Stroke Patients and Their Informal Caregivers, Combining Follow-up by a Case-manager and Access to an Internet Information Platform
- ClinicalTrials.gov ID
- NCT05928832
- Acronym / sponsor ID
- P-NAVISTROKE / 69HCL23_0237
- Conditions
- Stroke
- Keywords
- Stroke, Participation, Case-manager, Internet information platform
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
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 families must adapt quickly to the patient's new state of health and the new role of informal 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 informal 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 informal caregiver (increased perceived burden, decreased quality of life, socio-economic impact).
Patients and informal 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 individualized 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 programs 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 needs.
An hospital-to-home transition support program in partnership with patients and relatives using a "user-centered design" approach has been developed in order to best meet needs.
A first phase of co-construction has been conducted while 4 participatory workshops for (patients, informal caregivers, healthcare assistants and professionals in the social field) were carried out to precisely define and develop the program. The program was developed in based on data from the scientific literature, an inventory of existing systems and the experience of participants. During this phase a usability testing of the platform developed during the workshops with patients and informal caregivers following a Think Aloud method has also been conducted.
The hypothesis is that the implementation of this patient-centered post-stroke hospital/home transition program, combining an Internet platform and follow-up by a case-manager, is feasible within stroke center and will receive good acceptability from healthcare professionals, patients and informal caregivers.
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: Follow-up by a case-manager and access to the internet platformPatients in the intervention group will receive an information letter on their discharge presenting the follow-up from which they will benefit: call from the case-manager and access to the internet platform. |
| Control group | No intervention | –Patients randomized to the control group will receive the usual practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patient,
- Having had a first confirmed, ischemic or hemorrhagic stroke
- Hospitalized in a participating stroke center,
- Living at home before the stroke,
- Whose return home directly from the stroke center is planned
Key exclusion criteria (11 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
- Pregnant or breastfeeding women,
- Persons deprived of their liberty by a judicial or administrative decision,
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 |
|---|---|---|
| Follow-up by a case-manager and access to the internet platformPatients in the intervention group receive an information letter on their discharge presenting the follow-up from which they benefit:call from the case-manager and access to the internet platform. The case-manager meets the patient and/or informal caregiver on the day of discharge from hospital. He recontacts the patient and/or informal caregiver within 7 days after returning home. A follow-up is offered to patients and caregivers following their return home, according to the objectives defined during the initial interview. The total duration of the support is 6 months maximum including at least 4 contacts with the case-manager,but this is refined and adapted with the patient, according to needs. Similarly, the frequency and methods (face-to-face or remote) of contact varies according to the needs of the patients and the stage of support, and is defined by the case-manager and patient. Patients and/or informal caregivers is also able to contact the case-manager 'on request'. | Other | Intervention group |
Primary outcome
Feasibility of implementing the Navistroke program
Time frame: 6 months
Conclusion on the feasibility if the composite criteria is positive, namely: * Inclusion of 30 patients over a period of 4 months. * Realization of at least two exchanges out of the four defined in the follow-up with the case-manager for the 15 patients included in the intervention group. * Maintenance of the intervention during the 6-months study period
12 secondary outcomes
Patients - Quality of life of patients
Time frame: 6 months
Patients - Participation score of patients
Time frame: 6 months
Patients - Anxiety and depression scores between discharge and 6 months
Time frame: 6 months
Patients - Fatigue between discharge and 6 months
Time frame: 6 months
Patients - Social isolation between discharge and 6 month
Time frame: 6 months
Patients - Satisfaction
Time frame: 6 months
Patients - Information feeling
Time frame: 6 months
Informal caregivers - Evolution of the quality of life between the patient's discharge from hospital and 6 months
Time frame: 6 months
Informal caregivers - Level of perceived burden
Time frame: 6 months
Informal caregivers - Evolution of the global anxiety-depression score between discharge and 6 months after the patient's discharge from hospital
Time frame: 6 months
Informal caregivers - Satisfaction with the support and information received when returning home
Time frame: 6 months
Informal caregivers - Information feeling
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 42621673Delvallee M, Blazer A, Marchal M, Termoz A, Habchi O, Schott AM, Derex L, Haesebaert J. Feasibility and acceptability of a randomized controlled trial of a patient-centred transition program for stroke survivors and their caregivers-P-NAVISTROKE study. Disabil Rehabil. 2026 Aug 20:1-16. doi: 10.1080/09638288.2026.2719948. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up by a case-manager and access to the internet platform in people with Stroke, run by Hospices Civils de Lyon at 1 site in France.
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 15 inclusion and 11 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 MD HAESEBAERT (472684905 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?
Feasibility of implementing the Navistroke program (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 NCT05928832, 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 14 Aug 2023.