Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000151639
Ethics application status
Approved
Date submitted
24/01/2023
Date registered
16/02/2023
Date last updated
25/08/2024
Date data sharing statement initially provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Trial Evaluating Community Pharmacist-led Older Adult Fall Prevention Program
Scientific title
Evaluation of Community Pharmacist-led Fall Prevention Program among Community-Dwelling Older Adults on their Knowledge about Falls - A Randomised Controlled Trial
Secondary ID [1] 308697 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 328629 0
Condition category
Condition code
Public Health 325634 325634 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The fall prevention intervention administered by the community pharmacists involves screening, fall education, and medication review. A tabletop Flipchart will aid pharmacist education sessions, and participants will receive a booklet with information on fall prevention. These materials were created and validated specifically for this trial. A medication review form will be developed to aid pharmacists during the medication review session. If needed for any intervention, pharmacists will make a referral to the primary healthcare provider using a standardised referral form. Participants will also receive a fall calendar for them to take note of any falls at home.

At baseline, eligible participants will have to answer 4 self-administered questionnaires (demographic questionnaire, Fall Risk Assessment Questionnaire, Health-Related Quality of Life Questionnaire and Perspective of Fall Prevention Engagement Questionnaire). Participants will then be screened for fall risk with CDC-3 screening questions and given fall education by the study pharmacists. This should take approximately 30 minutes. Within one week, participants must bring their medications for review by pharmacists. This medication review session would take approximately 20 minutes. During the medication review, pharmacist can discuss and further educate participants on their medications in relation to falls. The intervention will be administered only at baseline. The intervention will be administered individually and in-person in rural and urban community pharmacies nationwide.

The intervention will be delivered by registered pharmacists working in the community pharmacy setting who will be specifically trained in fall prevention and data-gathering techniques using a validated training module. The training is designed specifically for this community pharmacist-led fall prevention intervention which will be offered through a workshop.

The participants will be required to return to the pharmacy twice for follow-up at one month and six months, but no additional intervention will be administered at these visits. During this visit, participants will be require to complete post-intervention questionnaires for the study and this take approximately 15 minutes. The same questionnaires will be given as before the intervention. At 6-month, participants will return back their fall calendars to the pharmacy.

The intervention fidelity will be evaluated by an audit of the checklist developed to document each step involved in the community pharmacist's delivery of the intervention.
Intervention code [1] 325161 0
Prevention
Comparator / control treatment
Usual standard pharmacy services (SPS) by community pharmacists in the community pharmacy setting. This include giving advice on minor health problems, selling nutritional supplements, over-the-counter (OTC) drugs and prescribed medications as well as participating in health promotional activities such as diabetes and diet counselling.
Participants in the control will be asked to bring their medications for study pharmacists to record but no intervention (medication review) will be done.
Control group
Active

Outcomes
Primary outcome [1] 333590 0
Knowledge score assessed by Fall Risk Assessment Questionnaires (FRAQ) scores
Timepoint [1] 333590 0
Baseline, 1-month (primary timepoint) and 6-month after intervention commencement
Secondary outcome [1] 417648 0
Health-related Quality of Life assessed by EQ-5D-5L instrument
Timepoint [1] 417648 0
Baseline, 1-month, and 6-month after intervention commencement
Secondary outcome [2] 417649 0
Perspective on fall prevention engagement assessed by a set of 7 validated questions from published study (Khong et al., 2017) https://doi.org/10.1007/s10433-016-0408-x
Timepoint [2] 417649 0
Baseline, 1-month, and 6-month after intervention commencement
Secondary outcome [3] 417650 0
Number of fall assessed by participant reporting and fall calendar
Timepoint [3] 417650 0
Baseline, 1-month, 3-month and 6-month after intervention commencement

Eligibility
Key inclusion criteria
1) Older adults aged 60 years and above
2) Consuming four or more chronic medications per day
3) Willingness to document self-reporting of falls at home (monthly calendar)
4) Capable of providing own consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Unable to communicate or writing in Malay or English language
2) Having sensory impairment
3) Participants are on palliative care
4) Resided in residential care facilities
5) Participate in other study related to falls
6) Diagnosed with mental disorder or neurological disease that might affect cognition
7) Cognitively impaired assessed by unable to understand instruction
8) An expected life expectancy shorter than six months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at the community pharmacy level.

The principle investigator will randomise the community pharmacies into intervention and control groups in a 1:1 ratio.

Randomisation of the community pharmacy will be decided using pre-generated randomised number lists generated by the investigator using Random Allocation Software Version 1.0.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is postulated that the community pharmacists' intervention can improve the knowledge score of the participants up to 20%, which was considered to be realistic and clinically relevant. With this rationale and setting the type 1 error of 5% (alpha=0.05) and power of 85% to detect a difference between the intervention and control group; by using the Power and Sample Size Calculation program version 3.1.2 (Dupont & Plummer, 1998), a sample size of minimum 89 participants per arm will be required for the analysis. Based on reported literature and allowing for a potential 30% possible post-randomization exclusion, loss to follow-up and drop-out (Wittes, 2002), a minimum sample size of 116 participants will be needed in each arm, making a total of 232 participants will be recruited.

All data will be entered and analysed using the Statistical Package for Social Science (SPSS) version 27. A significance level of 0.05 was used to test for statistical differences. If p-value calculated is less than 0.05, the effect is significantly different i.e. there is a difference in the results of the analysis. After data entry, a preliminary data screening will be conducted to identify any missing values and to correct data points. Following this editing process, the original data will be checked again to ensure no mistakes were made during the initial phase. Subsequently, the data sets will be investigated for any outliers or out-of-range values by graphical means (histogram or boxplots) and statistical means (Kolmogorov-Smirnov). If any outliers is detected, a thorough review will be performed to identify any likely inaccuracies or mistakes during the process of recording data or data entry.

In order to determine differences in proportion or association between the intervention and control groups for categorical or discreet variables, cross tabulation by means of Chi-square test will be utilised for this purpose. Fisher’s exact test, on the other hand, will be employed in analysing 2x2 tables of categorical data when one or more cells had an expected count of less than five. Comparison of continuous data between intervention and control groups will be carried out by using the independent samples t-test. In order to identify any changes in the knowledge scores between and within both groups at three different time intervals, the two-way repeated measures ANOVA test will be employed. Data will be analysed through the use of descriptive statistics by describing all the components of the questionnaires in a quantitative manner.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2023
Actual
30/04/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
26/09/2023
Date of last data collection
Anticipated
31/03/2024
Actual
8/04/2024
Sample size
Target
232
Accrual to date
Final
231
Recruitment outside Australia
Country [1] 25218 0
Malaysia
State/province [1] 25218 0
Nationwide

Funding & Sponsors
Funding source category [1] 312611 0
Government body
Name [1] 312611 0
Fundamental Research Grant Scheme (FRGS)
Country [1] 312611 0
Malaysia
Primary sponsor type
University
Name
Research Creativity and Management Office
Address
Research Creativity and Management Office, Division of Research & Innovation,
Universiti Sains Malaysia,
11800 Pulau Pinang
Country
Malaysia
Secondary sponsor category [1] 314689 0
None
Name [1] 314689 0
Address [1] 314689 0
Country [1] 314689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311932 0
Human Research Ethics Committee USM (HREC)
Ethics committee address [1] 311932 0
Ethics committee country [1] 311932 0
Malaysia
Date submitted for ethics approval [1] 311932 0
01/05/2022
Approval date [1] 311932 0
12/09/2022
Ethics approval number [1] 311932 0
USM/JEPeM/22050296

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122886 0
A/Prof Dr Balamurugan Tangiisuran
Address 122886 0
School of Pharmaceutical Sciences
Universiti Sains Malaysia
11800 Gelugor, Pulau Pinang
Country 122886 0
Malaysia
Phone 122886 0
+60 4 653 2579
Fax 122886 0
Email 122886 0
[email protected]
Contact person for public queries
Name 122887 0
Nur Izzati Shahabuddin
Address 122887 0
School of Pharmaceutical Sciences
Universiti Sains Malaysia
11800 Gelugor, Pulau Pinang
Country 122887 0
Malaysia
Phone 122887 0
+60 4 653 2211
Fax 122887 0
Email 122887 0
[email protected]
Contact person for scientific queries
Name 122888 0
Nur Izzati Shahabuddin
Address 122888 0
School of Pharmaceutical Sciences
Universiti Sains Malaysia
11800 Gelugor, Pulau Pinang
Country 122888 0
Malaysia
Phone 122888 0
+60 4 653 2211
Fax 122888 0
Email 122888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18108Study protocol    384957-(Uploaded-24-01-2023-18-45-17)-Study-related document.pdf
18109Ethical approval    384957-(Uploaded-09-02-2023-17-49-43)-Study-related document.pdf
18110Informed consent form    384957-(Uploaded-09-02-2023-17-49-20)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.