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)


SLCTR Registration Number


Date of Registration

11 Nov 2021

The date of last modification

Nov 11, 2021

Application Summary

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


Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

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


Study design


Randomized controlled trial


Masking not used


Standard therapy/practice




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

  1. Family caregivers of all patients who are admitted, diagnosed with stroke and treated in a medical ward of NHSL, CSTH, Base Hospital, Homagama.
  2. Family caregivers who have rated their stroke survivor's ability to perform Activities of Daily Living in the Barthel index - Sinhala version below 60 out of 100.
  3. Family caregivers who look after their stroke survivors at their home, once discharged.

Exclusion criteria

  1. Family caregivers who have cognitive impairments and vision or hearing impairments that would interfere with comprehension and expression will be excluded.
  2. Caregivers/ bystanders other than the family caregiver staying with the patient during the hospital stay will be excluded.
  3. Family caregivers who receive the assistance from a trained (paid/ non paid) caregivers at home will be excluded.

Primary outcome(s)


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)




Target number/sample size

200 (100 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


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

State of Ethics Review Approval



Date of Approval


Approval number


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.
Email: erc.fms.usjp@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

S. A. M. H. Kumara
Post Graduate Student
Faculty of Graduate Studies, University of Sri Jayewardenepura.



Contact Person for Public Queries

Prof. S. W. Wimalasekera
Associate Professor
Department of Physiology, Faculty of Medical Sciences, University of Sri Jayewardenepura.


Primary study sponsor/organization

Dr. A. A. T. D. Amarasekara (Grant holder)
Senior Lecturer
Department of Nursing and Midwifery, Faculty of Allied Health Sciences, University of Sri Jayewardenepura

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results