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Impact of Video-based Information Regarding Functional Rehabilitation

Primary Purpose

Stroke, Acute, Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
video-based patient information
Sponsored by
Hélène Corriveau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke, Acute focused on measuring Rehabilitation, Stroke, anxiety, stress, knowledge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CIUSSS de l'Estrie-CHUS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

video-based patient information

Arm Description

Viewing an explanatory video (8 minutes) to improve communication and understanding of stroke issues and stages of the continuum of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in anxiety
Hospital Anxiety and Depression Scale: detects anxiety and depressive disorders (2 sub-score on 21; higher score meaning higher anxiety symptoms)
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
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)

Full Information

First Posted
February 27, 2020
Last Updated
February 3, 2022
Sponsor
Hélène Corriveau
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1. Study Identification

Unique Protocol Identification Number
NCT04296981
Brief Title
Impact of Video-based Information Regarding Functional Rehabilitation
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hélène Corriveau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Anxiety, Stress, Knowledge, Attitudes, Practice
Keywords
Rehabilitation, Stroke, anxiety, stress, knowledge

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
video-based patient information
Arm Type
Experimental
Arm Description
Viewing an explanatory video (8 minutes) to improve communication and understanding of stroke issues and stages of the continuum of care
Intervention Type
Other
Intervention Name(s)
video-based patient information
Intervention Description
explanatory video (8 minutes) concerning communication, stroke issues and stages of the continuum of care
Primary Outcome Measure Information:
Title
Change in perceived stress
Description
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.
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).
Secondary Outcome Measure Information:
Title
Change in anxiety
Description
Hospital Anxiety and Depression Scale: detects anxiety and depressive disorders (2 sub-score on 21; higher score meaning higher anxiety symptoms)
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).
Title
Change in knowledge on intensive functional rehabilitation
Description
Home made questionnaire: 12 questions on intensive functional rehabilitation (total score on 12; higher score meaning higher knowledge on intensive fucn
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).
Title
Participants satisfaction regarding the video
Description
Home made questionnaire (12 questions regarding their appreciation of the video. Total score on 60:higher score meaning higher satisfaction)
Time Frame
before discharge from hospital (2-3 days after T1) (T2-part B).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Corriveau, PhD
Organizational Affiliation
CIUSSS de l'Estrie-CHUS and Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS de l'Estrie-CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Video-based Information Regarding Functional Rehabilitation

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