Clinical trial NCT03571152: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Caregivers
Educational videos
Subacute phase
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Practice level
timeFrame: 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 outcomes:
measure: Knowledge level
timeFrame: 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.
measure: Satisfaction level
timeFrame: 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.
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Cayetano Heredia
state: San Martín De Porres
Study officials:
name: Claudia M Sánchez Huamash, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.