Home » Trials » SLCTR/2023/013


Fall prevention for Older Community-Dwellers in Sri Lanka – An education Program to promote evidence–based practice by physiotherapists

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SLCTR Registration Number

SLCTR/2023/013


Date of Registration

02 Jun 2023

The date of last modification

Jun 02, 2023



Application Summary


Scientific Title of Trial

Fall prevention for Older Community-Dwellers in Sri Lanka – An education Program to promote evidence–based practice by physiotherapists


Public Title of Trial

The effect of an online falls prevention education program in enhancing the knowledge, confidence and exercise prescription vs standard practice in Sri Lankan Physiotherapists for the prevention of falls in older community dwellers in Sri Lanka


Disease or Health Condition(s) Studied

Falls in the elderly


Scientific Acronym

FPEP


Public Acronym

FPEP


Brief title

Effect of an online falls prevention education program in enhancing the knowledge,confidence and exercise prescription in Sri Lankan Physiotherapists.


Universal Trial Number

U1111-1279-2057


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

ERC: 2022/EC/55 Ethics review Committee, Faculty of Medicine, University of Peradeniya


Trial Details


What is the research question being addressed?

Is an online fall prevention education program able to enhance knowledge, confidence and exercise prescription in Sri Lankan physiotherapists compared to standard care?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Health services research


Study Phase

Not Applicable


Intervention(s) planned

  1. The study will be conducted in Sri Lanka. The education program will be provided online using Zoom, and the questionnaire will also be sent online using google Forms.
  2. a. Method of randomization: Simple randomization b. Unit of randomaization: On the enrolment each physiotherapist will be given a study ID number and this study ID number will be used as the unit of randomization. c. Method of sequence generation: Random number table d. Method of allocation concealment: None
  3. Intervention: An online education program The Fall prevention education program is adapted from a previous study which was conducted in Australia (Tiedemann et al., 2021). There are 4 modules in this education program. • Module 1: epidemiology and physiology of falls, • Module 2: fall risk assessment, • Module 3: fall prevention strategies and exercise prescription for falls • Module 4: fall prevention program implementation and management.

The education program has 2 sessions, 3.30 hours each 4. Control: Control will be a wait listed group who continue their normal practice throughout the data collection. 5. Standard practice: Whatever the individual physiotherapist is practicing for fall prevention in his/her clinical set up. The data collectors and the analysts will be blinded.


Inclusion criteria

Physiotherapists who are registered under the Sri Lankan Medical Council (SLMC) and working in Sri Lankan Government and private hospitals and clinics

• Physiotherapists who treat adults aged 60 years and older.

• Those who are with online access

Any Male or Female physiotherapists from the age of recruitment (20 years) until retirement (60 years) will be recruited.


Exclusion criteria

• Those who cannot understand the English language



Primary outcome(s)

1.
  1. The increase confidence levels assessed by Likert scale

  2. The change in knowledge assessed by a questionaaire

  3. Exercise prescription assessed by a questionnaire

[
  1. First assessment before randomization and second assessment 3 months after the intervention
  2. First assessment before randomization and second assessment 3 months after the intervention
  3. First assessment before randomization and second assessment 3 months after the intervention
]

Secondary outcome(s)

1.

None

[

None

]

Target number/sample size

130 in the intervention group and 130 in the control group


Countries of recruitment

Sri Lanka


Anticipated start date

2023-07-01


Anticipated end date

2024-04-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Not Applicable


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-11-29


Approval number

2022/EC/55


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Institutional Address:Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Telephone:0812396000
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

FMD Chellapillai
Lecturer (Probationary)
Department of Physiotherapy, Faculty of Allied Health Sciences, General Sir John Kotelawala Defence University

0772779477

cdhananjee@yahoo.com

Contact Person for Public Queries

Prof. Anula Kariyawasam
Professor
Department of Physiology, Faculty of Medicine, University of Peradeniya,

0718667836

tashiya2004@yahoo.com,


Primary study sponsor/organization

General Sir John Kotelawala Defence University

Kandawala Road, Dehiwala-Mount Lavinia 10390
0112 635 268


https://kdu.ac.lk/

Secondary study sponsor (If any)







Trial Completion details


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

Yes


IPD sharing plan description

Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices). The statistical analysis plan will also be shared. Data will be available beginning 3 months and ending 5 years following article publication.Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.Data will be shared to achieve the aims in an approved proposal and Meta analysis. Proposals should be directed to chellapillaifmd@kdu.ac.lk . To gain access, data requestors will need to sign a data access agreement. The link will be provided once the data is uploaded.


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