Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke

March 23, 2020 updated by: Claudia Sanchez, Universidad Peruana Cayetano Heredia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • San Martín De Porres
      • Lima, San Martín De Porres, Peru, Lima 31
        • Universidad Cayetano Heredia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational videos
Subjects allocated in this arms will receive the educational videos.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practice level
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.
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Knowledge level
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.
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.
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.
Satisfaction level
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Claudia M Sánchez Huamash, BSc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

December 2, 2018

Study Completion (Actual)

December 10, 2018

Study Registration Dates

First Submitted

June 17, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan description. No applicable.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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