Stroke, AcuteNCT04296981
Impact of Video-based Information Regarding Functional Rehabilitation
A study testing video-based patient information in people with Stroke, Acute and Anxiety, run by Hélène Corriveau at 1 site in Canada.
Trial summary
At CHUS Fleurimont, one in five patients hospitalized for this condition needs to be transferred to an intensive functional rehabilitation unit (URFI) located in another establishment of the Centre intégré universitaire de santé et de service sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Anxiety, Stress
- What is being tested?
- video-based patient information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to 15 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have had a stroke
- be subject (or have a relative subject) to a request for admission to intensive functional rehabilitation sent or to come
- be able to communicate and understand the guidelines for participating in the assessments and viewing the video
- understand French orally and in writing
Who cannot join
- having already made a stay in intensive functional rehabilitation following a stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Video-based Information Regarding Functional Rehabilitation (RFI) on Knowledge, Stress and Anxiety of People Who Have Suffered a Stroke and Their Relatives
At CHUS Fleurimont, one in five patients hospitalized for this condition needs to be transferred to an intensive functional rehabilitation unit (URFI) located in another establishment of the Centre intégré universitaire de santé et de service sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de Estrie-CHUS). Patients and their relatives must therefore adapt to a new environment and a new care team, which can cause additional concern and uncertainty for their new condition. Thus, the importance of educating the patient and their family so that they understand the nature of the stroke, as well as the elements and stages of rehabilitation that lie ahead, are essentials so that they can make an informed choice about acceptance and type of rehabilitation. However, to date, little material is available to facilitate communication between the professional and the patient and his/her family. In this perspective, our research team has developed a video which aims to improve the knowledge of people and loved ones on intensive functional rehabilitation (RFI) and its care settings. The objectives of this study are:
- Evaluate the effect of viewing the video on post-stroke patients and their relatives on:
Read more
- Perceived stress
- Anxiety
- Knowledge on intensive functional rehabilitation
- Measure participants satisfaction regarding the video
- Evaluate the association between socio-demographic outcomes (age, sex, degree of impairment, relation with the patient, NIHSS, MRS) and perceived stress, anxiety and knowledge regarding rehabilitation.
Read the detailed description
Rational :
One of the main recommendations of a committee of experts on the provision of rehabilitation services in Quebec is that people who have had a stroke should start rehabilitation as soon as possible once their medical condition has stabilized. This rehabilitation therefore begins in the hospital center, in acute care, but can continue if necessary in a rehabilitation center specialized for this purpose. At CHUS Fleurimont, one in five patients hospitalized for this condition needs to be transferred to an intensive functional rehabilitation unit (URFI) located in another establishment of the Centre intégré universitaire de santé et de service sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de Estrie-CHUS). Patients and their relatives must therefore adapt to a new environment and a new care team, which can cause additional concern and uncertainty for their new condition. Thus, the importance of educating the patient and their family so that they understand the nature of the stroke, as well as the elements and stages of rehabilitation that lie ahead, are essentials so that they can make an informed choice about acceptance and type of rehabilitation. However, to date, little material is available to facilitate communication between the professional and the patient and his/her family. In this perspective, our research team has developed a video which aims to improve the knowledge of people and loved ones on intensive functional rehabilitation (RFI) and its care settings.
Objective :
Objectives of this project are :
- Evaluate the effect of viewing the video on post-stroke patients and their relatives on:
- Perceived stress
- Anxiety
- Knowledge on intensive functional rehabilitation
- Measure participants satisfaction regarding the video
- Evaluate the association between socio-demographic outcomes (age, sex, degree of impairment, relation with the patient, NIHSS, MRS) and perceived stress, anxiety and knowledge regarding rehabilitation.
Method :
In order to meet the objectives of the study, a pre-experimental study (pré-/post-test with a single group will be used. A first data collection will take place (T1) as soon as the consent form is signed, comprising the following variables: 1) socio-demographic data, 2) perceived stress, 3) level of anxiety and 4) knowledge of intensive functional rehabilitation. The video will then be viewed once by the participants during this same visit. The Intensive functional rehabilitation Knowledge Questionnaire will be re-administered immediately after viewing the video. Before the discharge from the stroke unit, between 24 and 72 hours after recruitment, a second assessment (T2) will take place.The assessments will then be administered a second time. In addition, a questionnaire on satisfaction regarding the video will be administered.
Anticipated results :
If the results of this study are conclusives, the video could be used with all patients requiring intensive functional rehabilitation following a stroke, but also with patients presenting other health problems such as head trauma and other polytrauma requiring intensive functional rehabilitation. The video could also be used and adapted for the other CIUSSS hospital centers of Estrie-CHUS such as the CH center hospitalier Mégantic, Granby and Cowansville which also treat this type of clientele.
- Conditions
- Stroke, Acute, Anxiety, Stress, Knowledge, Attitudes, Practice
- Being tested
- video-based patient information
- Keywords
- Rehabilitation, Stroke, anxiety, stress, knowledge
- Medical subject headings
- Stroke, Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-based patient informationOther
explanatory video (8 minutes) concerning communication, stroke issues and stages of the continuum of care
| Study group | Role | What they receive |
|---|---|---|
| video-based patient information | Experimental | Viewing an explanatory video (8 minutes) to improve communication and understanding of stroke issues and stages of the continuum of care Receives: Other: video-based patient information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress
Perceived Stress Scale where (total score on 50: higher score meaning higher stress). The scale assesses the extent to which a person perceives life situations as stressful overall.
Measured: Change from baseline (i.e. before viewing the video (T1)) and before discharge from hospital (2-3 days after T1) (T2-part B).
Secondary outcomes (3)
Change in anxiety
Hospital Anxiety and Depression Scale: detects anxiety and depressive disorders (2 sub-score on 21; higher score meaning higher anxiety symptoms)
Measured: Change from baseline (i.e. before viewing the video (T1)) and before discharge from hospital (2-3 days after T1) (T2-part B).
Change in knowledge on intensive functional rehabilitation
Home made questionnaire: 12 questions on intensive functional rehabilitation (total score on 12; higher score meaning higher knowledge on intensive fucn
Measured: Change from baseline (i.e.before viewing the video (T1)), and immediately after viewing the video (T2-part A) and before discharge from hospital (2-3 days after T1) (T2-part B).
Participants satisfaction regarding the video
Home made questionnaire (12 questions regarding their appreciation of the video. Total score on 60:higher score meaning higher satisfaction)
Measured: before discharge from hospital (2-3 days after T1) (T2-part B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Apr 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hélène Corriveau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hélène Corriveau, Université de Sherbrooke
- Investigators
- Hélène Corriveau, PhD, Principal investigator, CIUSSS de l'Estrie-CHUS and Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296981
- Sponsor's protocol ID
- 2020-3610
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Video-based Information Regarding Functional Rehabilitation (RFI) on Knowledge, Stress and Anxiety of People Who Have Suffered a Stroke and Their Relatives
- ClinicalTrials.gov ID
- NCT04296981
- Acronym / sponsor ID
- 2020-3610
- Conditions
- Stroke, Acute, Anxiety, Stress, Knowledge, Attitudes, Practice
- Keywords
- Rehabilitation, Stroke, anxiety, stress, knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hélène CorriveauUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 5 Mar 2020 (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.
At CHUS Fleurimont, one in five patients hospitalized for this condition needs to be transferred to an intensive functional rehabilitation unit (URFI) located in another establishment of the Centre intégré universitaire de santé et de service sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de Estrie-CHUS). Patients and their relatives must therefore adapt to a new environment and a new care team, which can cause additional concern and uncertainty for their new condition. Thus, the importance of educating the patient and their family so that they understand the nature of the stroke, as well as the elements and stages of rehabilitation that lie ahead, are essentials so that they can make an informed choice about acceptance and type of rehabilitation. However, to date, little material is available to facilitate communication between the professional and the patient and his/her family. In this perspective, our research team has developed a video which aims to improve the knowledge of people and loved ones on intensive functional rehabilitation (RFI) and its care settings. The objectives of this study are:
- Evaluate the effect of viewing the video on post-stroke patients and their relatives on:
- Perceived stress
- Anxiety
- Knowledge on intensive functional rehabilitation
- Measure participants satisfaction regarding the video
- Evaluate the association between socio-demographic outcomes (age, sex, degree of impairment, relation with the patient, NIHSS, MRS) and perceived stress, anxiety and knowledge regarding rehabilitation.
Detailed description
Rational :
One of the main recommendations of a committee of experts on the provision of rehabilitation services in Quebec is that people who have had a stroke should start rehabilitation as soon as possible once their medical condition has stabilized. This rehabilitation therefore begins in the hospital center, in acute care, but can continue if necessary in a rehabilitation center specialized for this purpose. At CHUS Fleurimont, one in five patients hospitalized for this condition needs to be transferred to an intensive functional rehabilitation unit (URFI) located in another establishment of the Centre intégré universitaire de santé et de service sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de Estrie-CHUS). Patients and their relatives must therefore adapt to a new environment and a new care team, which can cause additional concern and uncertainty for their new condition. Thus, the importance of educating the patient and their family so that they understand the nature of the stroke, as well as the elements and stages of rehabilitation that lie ahead, are essentials so that they can make an informed choice about acceptance and type of rehabilitation. However, to date, little material is available to facilitate communication between the professional and the patient and his/her family. In this perspective, our research team has developed a video which aims to improve the knowledge of people and loved ones on intensive functional rehabilitation (RFI) and its care settings.
Objective :
Objectives of this project are :
- Evaluate the effect of viewing the video on post-stroke patients and their relatives on:
- Perceived stress
- Anxiety
- Knowledge on intensive functional rehabilitation
- Measure participants satisfaction regarding the video
- Evaluate the association between socio-demographic outcomes (age, sex, degree of impairment, relation with the patient, NIHSS, MRS) and perceived stress, anxiety and knowledge regarding rehabilitation.
Method :
In order to meet the objectives of the study, a pre-experimental study (pré-/post-test with a single group will be used. A first data collection will take place (T1) as soon as the consent form is signed, comprising the following variables: 1) socio-demographic data, 2) perceived stress, 3) level of anxiety and 4) knowledge of intensive functional rehabilitation. The video will then be viewed once by the participants during this same visit. The Intensive functional rehabilitation Knowledge Questionnaire will be re-administered immediately after viewing the video. Before the discharge from the stroke unit, between 24 and 72 hours after recruitment, a second assessment (T2) will take place.The assessments will then be administered a second time. In addition, a questionnaire on satisfaction regarding the video will be administered.
Anticipated results :
If the results of this study are conclusives, the video could be used with all patients requiring intensive functional rehabilitation following a stroke, but also with patients presenting other health problems such as head trauma and other polytrauma requiring intensive functional rehabilitation. The video could also be used and adapted for the other CIUSSS hospital centers of Estrie-CHUS such as the CH center hospitalier Mégantic, Granby and Cowansville which also treat this type of clientele.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video-based patient information | Experimental | Other: video-based patient informationViewing an explanatory video (8 minutes) to improve communication and understanding of stroke issues and stages of the continuum of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have had a stroke
- be subject (or have a relative subject) to a request for admission to intensive functional rehabilitation sent or to come
- be able to communicate and understand the guidelines for participating in the assessments and viewing the video
- understand French orally and in writing
Key exclusion criteria (1 listed)
- having already made a stay in intensive functional rehabilitation following a stroke
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 |
|---|---|---|
| video-based patient informationexplanatory video (8 minutes) concerning communication, stroke issues and stages of the continuum of care | Other | video-based patient information |
Primary outcome
Change in perceived stress
Time frame: Change from baseline (i.e. before viewing the video (T1)) and before discharge from hospital (2-3 days after T1) (T2-part B).
Perceived Stress Scale where (total score on 50: higher score meaning higher stress). The scale assesses the extent to which a person perceives life situations as stressful overall.
3 secondary outcomes
Change in anxiety
Time frame: Change from baseline (i.e. before viewing the video (T1)) and before discharge from hospital (2-3 days after T1) (T2-part B).
Change in knowledge on intensive functional rehabilitation
Time frame: Change from baseline (i.e.before viewing the video (T1)), and immediately after viewing the video (T2-part A) and before discharge from hospital (2-3 days after T1) (T2-part B).
Participants satisfaction regarding the video
Time frame: before discharge from hospital (2-3 days after T1) (T2-part B).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Hélène Corriveau, PhD principal investigator
CIUSSS de l'Estrie-CHUS and Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video-based patient information in people with Stroke, Acute and Anxiety, run by Hélène Corriveau at 1 site in Canada.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 7 Feb 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress (time frame: Change from baseline (i.e. before viewing the video (T1)) and before discharge from hospital (2-3 days after T1) (T2-part B).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.