- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296981
Impact of Video-based Information Regarding Functional Rehabilitation
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 4C4
- CIUSSS de l'Estrie-CHUS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- having already made a stay in intensive functional rehabilitation following a stroke
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: video-based patient information
Viewing an explanatory video (8 minutes) to improve communication and understanding of stroke issues and stages of the continuum of care
|
explanatory video (8 minutes) concerning communication, stroke issues and stages of the continuum of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline (i.e. before viewing the video (T1)) and before discharge from hospital (2-3 days after T1) (T2-part B).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Hospital Anxiety and Depression Scale: detects anxiety and depressive disorders (2 sub-score on 21; higher score meaning higher anxiety symptoms)
|
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).
|
Home made questionnaire: 12 questions on intensive functional rehabilitation (total score on 12; higher score meaning higher knowledge on intensive fucn
|
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).
|
Home made questionnaire (12 questions regarding their appreciation of the video.
Total score on 60:higher score meaning higher satisfaction)
|
before discharge from hospital (2-3 days after T1) (T2-part B).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hélène Corriveau, PhD, CIUSSS de l'Estrie-CHUS and Université de Sherbrooke
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-3610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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