NCT03571152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

June 17, 2018

Last Update Submit

March 23, 2020

Conditions

Keywords

CaregiversEducational videosSubacute phase

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Knowledge level

    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

    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.

Study Arms (1)

Educational videos

EXPERIMENTAL

Subjects allocated in this arms will receive the educational videos.

Other: Educational videos

Interventions

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.

Educational videos

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Cayetano Heredia

Lima, San Martín de Porres, Lima 31, Peru

Location

Related Publications (7)

  • Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.

    PMID: 24505342BACKGROUND
  • Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part I: Outcome. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):399-405. doi: 10.1016/s0003-9993(95)80567-2.

    PMID: 7741608BACKGROUND
  • Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.

    PMID: 15502272BACKGROUND
  • Karthikbabu S, Chakrapani M, Ganeshan S, Rakshith KC, Nafeez S, Prem V. A review on assessment and treatment of the trunk in stroke: A need or luxury. Neural Regen Res. 2012 Sep 5;7(25):1974-7. doi: 10.3969/j.issn.1673-5374.2012.25.008.

    PMID: 25624827BACKGROUND
  • Duncan P, Studenski S, Richards L, Gollub S, Lai SM, Reker D, Perera S, Yates J, Koch V, Rigler S, Johnson D. Randomized clinical trial of therapeutic exercise in subacute stroke. Stroke. 2003 Sep;34(9):2173-80. doi: 10.1161/01.STR.0000083699.95351.F2. Epub 2003 Aug 14.

    PMID: 12920254BACKGROUND
  • 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.

    PMID: 20511303BACKGROUND
  • 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.

    PMID: 24467676BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Claudia M Sánchez Huamash, BSc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2018

First Posted

June 27, 2018

Study Start

September 1, 2018

Primary Completion

December 2, 2018

Study Completion

December 10, 2018

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

There is no plan description. No applicable.

Locations