Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Educational videos
Sponsored by

About this trial
This is an interventional other trial for Stroke focused on measuring Caregivers, Educational videos, Subacute phase
Eligibility Criteria
Inclusion Criteria:
- Familiar or known of patients in the subacute phase of ischemic stroke.
- Familiar or known of stable dependent patients with diagnosis of hemiplegia.
- Caregiver aged 18-65 years.
Exclusion Criteria:
- Caregiver with cognitive , severe auditory and/or visual problems.
- Caregiver of patients who do not collaborate due to their cognitive, neurological or psychiatric conditions.
- Caregiver of patients with comorbidities that affect mobility, such as other neurological disorders, orthopedic and/or traumatological alterations.
Sites / Locations
- Universidad Cayetano Heredia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational videos
Arm Description
Subjects allocated in this arms will receive the educational videos.
Outcomes
Primary Outcome Measures
Practice level
We will use the "evaluation form of the practice level", a check list with items that the caregiver should perform for the 8 activities represented in the 8 videos, for each activity a minimum of 4 items and a maximum of 9 items will be evaluated. The number of items for each activity is summed, so the total number of items is 49. Therefore, the minimum score is 0% (the caregiver performed 0% of items) and the maximum score is 100% (the caregiver performed 100% of items). The higher percentage represents a better result. This instrument will be review for experts, so the number of items could change.
Secondary Outcome Measures
Knowledge level
We will use the "evaluation form of the knowledge level", which was designed for the study, a questionnaire with one-answer questions related to 8 activities represented in the 8 videos, for each activity a minimum of 2 questions and a maximum of 4 questions will be evaluated. The number of questions for each activity is summed, so the total number of questions is 25. Therefore, the minimum score is 0% (the caregiver answered correctly 0% of questions) and the maximum score is 100% (the caregiver answered correctly 100% of questions). The higher percentage represents a better result. This instrument will be review for experts, so the number of questions could change.
Satisfaction level
We will use the "evaluation form of the satisfaction level", which was designed for the study, a questionnaire with 3 questions of Likert scale and 2 opened questions related to the 8 videos. Therefore, the results will be reported according to each question. This instrument will be review for experts, so this could change.
Full Information
NCT ID
NCT03571152
First Posted
June 17, 2018
Last Updated
March 23, 2020
Sponsor
Universidad Peruana Cayetano Heredia
1. Study Identification
Unique Protocol Identification Number
NCT03571152
Brief Title
Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke
Official Title
Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 2, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Peruana Cayetano Heredia
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
Stroke is the second cause of death and third of disability in the adult population, By 2020 it is projected like the fourth cause of disability-adjusted life year (DALY) and by 2030 it is estimated that it will lead the global burden of morbidity from chronic noncommunicable diseases. As a consequence of stroke, patients show a certain degree of dependence and spend most of their time with a caregiver, especially since the subacute phase of the stroke. 80% of patients who survive have motor problems. The proper care during the first three months will significantly improve until 95% the patient rehabilitation. Caregivers have reported the need for information about clinical, prevention and treatment of stroke, like information about specific tasks of patient care, mobilizations, exercises, etc. Therefore, it is necessary to train and educate the caregivers in physical aspects of care, recovery and secondary prevention. However, oversaturated health systems, insufficient number of specialists, social inequity, limited coverage and speed of access to health services are factors that make difficult to educate caregivers. Studies have demonstrated that the Information Technology applied to health is a promising solution to educate and empower the patient, carer and family. For instance, the use of educational videos to improve the level of practice or knowledge of patients with chronic pain and chronic obstructive pulmonary disease. This project aims to evaluate the efficacy of the use of educational videos for caregivers of patients in subacute phase of stroke through of the change of the level of practice, knowledge and satisfaction.
Detailed Description
Sample size A sample size of 10 participants, it is possible to detect minimum differences of 10% to 20%, with standard deviations of 5% to 10%.
Statistical analysis plan The data collected will be entered into a database in Microsoft Excel, to be analyzed by the Epi Info statistical program. The qualitative variables will be analyzed by frequencies and percentages, the quantitative variables by arithmetic mean and standard deviation, some of them categorized for its interpretation. The bivariate analysis between two qualitative variables will be carried out using Fisher's exact test, the analysis between a qualitative variable and a quantitative one will be carried out through the Mann-Whitney U tests (non-normal distribution) and Student's t test (normal distribution). After the intervention, the level of practice and knowledge of the caregivers on the basic management of patients in the subacute phase of the stroke will generate a variable called "change of score", whose p-value should be less than 0.05.
Plan for missing data Due to the characteristics of the intervention, the investigators do not expect much loss to follow up patients after recruitment. However, all missing data will be reported as such.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Caregivers, Educational videos, Subacute phase
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-experimental study design The level of practice and knowledge of the caregiver will be evaluated according to the video(s) corresponding to the session. Patient participation is expected for the evaluation of the caregiver's level of practice. After thirty minutes of use of the video, the level of practice and knowledge of the caregiver will be evaluated again for the same video. In each session this methodology will continue until the eighth video. At the end of all the videos, the level of satisfaction of the caregivers in relation to the videos will be evaluated.
Masking
None (Open Label)
Masking Description
No masking.
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational videos
Arm Type
Experimental
Arm Description
Subjects allocated in this arms will receive the educational videos.
Intervention Type
Other
Intervention Name(s)
Educational videos
Intervention Description
The level of practice and knowledge of the caregiver will be evaluated according to the video(s) corresponding to the session. Patient participation is expected for the evaluation of the caregiver's level of practice. After thirty minutes of use of the video, the level of practice and knowledge of the caregiver will be evaluated again for the same video. In each session this methodology will continue until the eighth video. At the end of all the videos, the level of satisfaction of the caregivers in relation to the videos will be evaluated.
Primary Outcome Measure Information:
Title
Practice level
Description
We will use the "evaluation form of the practice level", a check list with items that the caregiver should perform for the 8 activities represented in the 8 videos, for each activity a minimum of 4 items and a maximum of 9 items will be evaluated. The number of items for each activity is summed, so the total number of items is 49. Therefore, the minimum score is 0% (the caregiver performed 0% of items) and the maximum score is 100% (the caregiver performed 100% of items). The higher percentage represents a better result. This instrument will be review for experts, so the number of items could change.
Time Frame
Before and after 30 minutes of watching each video the participant will be evaluated. This method will be used for the 8 videos developed. Therefore, there will be a change in the practice level.
Secondary Outcome Measure Information:
Title
Knowledge level
Description
We will use the "evaluation form of the knowledge level", which was designed for the study, a questionnaire with one-answer questions related to 8 activities represented in the 8 videos, for each activity a minimum of 2 questions and a maximum of 4 questions will be evaluated. The number of questions for each activity is summed, so the total number of questions is 25. Therefore, the minimum score is 0% (the caregiver answered correctly 0% of questions) and the maximum score is 100% (the caregiver answered correctly 100% of questions). The higher percentage represents a better result. This instrument will be review for experts, so the number of questions could change.
Time Frame
Before and after 30 minutes of watching each video, the participant will be evaluated. This method will be used for the 8 videos developed. Therefore, there will be a change in the knowledge level.
Title
Satisfaction level
Description
We will use the "evaluation form of the satisfaction level", which was designed for the study, a questionnaire with 3 questions of Likert scale and 2 opened questions related to the 8 videos. Therefore, the results will be reported according to each question. This instrument will be review for experts, so this could change.
Time Frame
After of watching all the videos, the participant will be evaluated. Minimum 1 video and maximum 3 videos will be evaluated per day. Therefore, minimum 3 days and maximum 8 days will be needed. The days will not be necessarily followed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Familiar or known of patients in the subacute phase of ischemic stroke.
Familiar or known of stable dependent patients with diagnosis of hemiplegia.
Caregiver aged 18-65 years.
Exclusion Criteria:
Caregiver with cognitive , severe auditory and/or visual problems.
Caregiver of patients who do not collaborate due to their cognitive, neurological or psychiatric conditions.
Caregiver of patients with comorbidities that affect mobility, such as other neurological disorders, orthopedic and/or traumatological alterations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Sánchez Huamash, BSc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Cayetano Heredia
City
Lima
State/Province
San Martín De Porres
ZIP/Postal Code
Lima 31
Country
Peru
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan description. No applicable.
Citations:
PubMed Identifier
24505342
Citation
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Results Reference
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PubMed Identifier
7741608
Citation
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Results Reference
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PubMed Identifier
15502272
Citation
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Results Reference
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PubMed Identifier
25624827
Citation
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Results Reference
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PubMed Identifier
12920254
Citation
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Results Reference
background
PubMed Identifier
20511303
Citation
Di Monaco M, Trucco M, Di Monaco R, Tappero R, Cavanna A. The relationship between initial trunk control or postural balance and inpatient rehabilitation outcome after stroke: a prospective comparative study. Clin Rehabil. 2010 Jun;24(6):543-54. doi: 10.1177/0269215509353265.
Results Reference
background
PubMed Identifier
24467676
Citation
Young ME, Lutz BJ, Creasy KR, Cox KJ, Martz C. A comprehensive assessment of family caregivers of stroke survivors during inpatient rehabilitation. Disabil Rehabil. 2014;36(22):1892-902. doi: 10.3109/09638288.2014.881565. Epub 2014 Jan 28.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/20592268
Description
The role of caregiver involvement in upper-limb treatment in individuals with subacute stroke.
Learn more about this trial
Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke
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