Home » Trials » SLCTR/2021/031
Developing an educational programme for family caregivers of dependent stroke survivors on care related to activities of daily living (ADL)
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SLCTR Registration Number
SLCTR/2021/031
Date of Registration
The date of last modification
Nov 11, 2021
Scientific Title of Trial
Developing an educational programme for family caregivers of dependent stroke survivors on care related to activities of daily living (ADL)
Public Title of Trial
A caregiver-training educational programme for family caregivers compared to standard care in dependent stroke survivors to improve the competencies of care related to Activities of Daily Living
Disease or Health Condition(s) Studied
Stroke
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1267-8631
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Will an educational programme for family caregivers provide knowledge, enhance skills, and meet the attitudinal changes required to provide better care for dependent stroke survivors?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
1.Study setting: Male/ Female medical wards of National Hospital Sri Lanka, Colombo South Teaching Hospital and Base Hospital Homagama.
2.Randomization:
a) Method of randomization: Simple randomization method is used to randomize the sample. 2(b) Unit of randomization Family caregivers of dependent stroke survivors whose family members who have been treated in the selected study settings. c) Sequence generations will be conducted using computerized random number generator. 2(d) Allocation concealment sequentially numbered opaque, sealed envelopes (SNOSE) will be used as the method of allocation concealment and this will be conducted by a separate individual who is not actively contributed to the RCT data collection.
3. Intervention: According to the analysis of the Phase I, background information of the nature of the educational programme and educational programme has been developed accordingly and it has been developed for family caregivers of dependent stroke survivors. This intervention includes two main study materials which are a mobile application and a printed caregiving manual.
Mobile application contains series of videos educating family caregivers of dependent stroke survivors on improving caregiving practices. (i.e., How to feed a patient orally, how to feed a patient via NG tube, How to care for a patient with urinary catheter, How to give a bed bath and improve the personal hygiene etc.) Further, this educational programme contains some poster presentations which can be displayed on the mobile application screen in order to improve the knowledge of the family caregivers.
The printed version of caregiver manual is used as an alternative method for family caregivers who are having issues of operating mobile application due to any reason. This has also been developed according to the findings of the pre interventional phase of the study (Phase I). This material includes step by step caregiving guidance on selected caregiving procedures as same as the videos used in mobile application. Further, this booklet also includes the different section which caters the education of family caregivers of dependent stroke survivors.
These educational materials will be used additionally to the standard medical and nursing care as well as post stroke follow up care in the intervention group when the randomized control trial is proceeding. After administering the educational materials family caregivers will be met for additional support and specific care related guidance as required by them within 1 week.
Control group participants of the study will receive only the usual standard medical management, nursing care and post stroke follow up care and therapy. Further, usually practicing rehabilitation will be provided and practicing methods of health education will be conducted to the participants.
However, after completion of the study and analysis, if the educational materials are found to be effective control group participants also will be obtained the educational materials.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Improvement of the family caregivers’ knowledge, attitudes and caregiving practices on Activities of Daily Living. Knowledge, attitudes and perceived skills will be assessed using the structured questionnaire.Actual skills of the family caregivers of the dependent stroke survivors will be assessed by using the developed observational checklist. |
[ Primary outcomes will be assessed after one week of hospital discharge. ] |
Secondary outcome(s)
1.
None |
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Target number/sample size
200 (100 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-12-15
Anticipated end date
2022-03-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University research grant award Department of Nursing and Midwifery, Faculty of Allied Health Sciences, University of Sri Jayewardenepura. Grant No. ASP/01/RE/MED/2017/69
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-06-26
Approval number
53/17
Details of Ethics Review Committee
Name: | Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayewardenepura |
Institutional Address: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka. |
Telephone: | +94112758000 |
Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
S. A. M. H. Kumara
Post Graduate Student
Faculty of Graduate Studies,
University of Sri Jayewardenepura.
0776900320
mkumara200@gmail.com
Contact Person for Public Queries
Prof. S. W. Wimalasekera
Associate Professor
Department of Physiology,
Faculty of Medical Sciences,
University of Sri Jayewardenepura.
0777487203
savithriww@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results