Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05192408 |
| Other study ID # |
2021/00742 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2022 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
December 2023 |
| Source |
National Healthcare Group Polyclinics |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In the short term, the study will provide insight into the effectiveness of multi-component
intervention for reducing Fear of falling (FoF) in community-dwelling older adults. Effective
interventions will be incorporated into existing programs for frailty and falls prevention in
primary care. Reducing FoF will break the cycle of physical activity restriction, functional
decline and further falls in older adults. Long term potential benefits include improving the
health status of older adults and thus reducing healthcare utilization.
The primary aim is to compare the effectiveness of a multi-component intervention comprising
exercise recommendations, cognitive behavioural therapy (CBT) components and motivational
interviewing (MI) based telephone review against usual care for reducing Fear of Falling
(FoF) in community- dwelling older adults.
Secondary aims include to compare the effectiveness of the multi-component intervention
against usual care for increasing physical activity and reducing falls in community- dwelling
older adults.
The hypothesis is that the multi-component intervention will be more effective as compared to
usual care for reducing FoF and falls and increasing physical activity in community- dwelling
older adults.
Description:
In the short term, the study will provide insight into the effectiveness of multi-component
intervention for reducing Fear of falling (FoF) in community-dwelling older adults. Effective
interventions will be incorporated into existing programs for frailty and falls prevention in
primary care. Reducing FoF will break the cycle of physical activity restriction, functional
decline and further falls in older adults. Long term potential benefits include improving the
health status of older adults and thus reducing healthcare utilization.
The primary aim is to compare the effectiveness of a multi-component intervention comprising
exercise recommendations, cognitive behavioural therapy (CBT) components and motivational
interviewing (MI) based telephone review against usual care for reducing Fear of Falling
(FoF) in community- dwelling older adults.
Secondary aims include to compare the effectiveness of the multi-component intervention
against usual care for increasing physical activity and reducing falls in community- dwelling
older adults.
The hypothesis is that the multi-component intervention will be more effective as compared to
usual care for reducing FoF and falls and increasing physical activity in community- dwelling
older adults.
Sample size was calculated with reference to effect sizes from meta-analyses where effect
sizes of 0.28 and 0.33 were found.
The sample size calculation was based on effect size of 0.3 difference in FoF between the
intervention and comparator groups; with power of 80% and significance level of 0.05, 175
patients will be needed in each group. Assuming attrition rate of 20%, 210 participants in
each group, or a total of 420 participants, would be needed.
Recruitment procedures Recruitment will take place at all National Healthcare Group
Polyclinics over a period of 12 months.
All healthcare staff including doctors, nurses, physiotherapists and care coordinators (CCs)
in recruiting clinics will be briefed about the study and inclusion and exclusion criteria.
Potential participants will be recruited on a case encounter basis when they attend at the
clinics for follow-up visits. The above-mentioned healthcare staff will refer potential
participants who meet the inclusion criteria to any of the study team members. Study team
members who encounter suitable potential participants will refer them to another study team
member in clinic for recruitment if available, i.e., nurses in study team may cross refer
their patients to each other for recruitment.
Study team members proficient in potential participants' language will explain the study and
clarify any doubts using the Participant Information Sheet, take written informed consent and
administer the baseline questionnaire.
Data Collection Tools III) Fear of falling (FoF) will be screened using the Single Question
on FoF and Activity Restriction (SQ-FAR) and measured using the Short Falls Efficacy Scale -
International (FES-I) The SQ-FAR is a single question 'Are you afraid of falling?' used as a
screening tool for FoF. It was found to have moderate agreement of 87.8% (Kappa=0.57) with
the Falls Efficacy Scale-International (FES-I) in community dwelling adults aged 65 to 70
years old. Responses include 'no', 'yes' and 'yes, a lot', 'yes' and 'yes, a lot' indicate
presence of FoF.
The Short FES-I is a 7-item measure of "fear of falling" and has been demonstrated to have
good reliability and validity. It was also evaluated in Malaysia and showed good internal
consistency, test-retest reliability, construct validity, and responsiveness, with Cronbach's
alpha of 0.905 and intraclass correlation coefficient 0.997 for the English version. Scores
are calculated by totaling responses for each item, with a range from minimum 7 (no concern
about falling) to maximum 28 (severe concern about falling). 7 to 8 points indicates low
concern, 9 to 13 indicates moderate concern and 14 to 28 indicates high concern.
IV) Physical Activity levels will be measured using the Incidental and Planned Exercise
Questionnaire: Weekly Average (IPEQ -WA) The IPEQ consists of 10 questions which measure type
and amount of physical activity and provides estimates of the frequency and duration of
planned exercise and day-to-day activities. Validation in a population of older adults showed
that IPAQ-WA had excellent test-retest reliability, with intraclass correlation coefficient
0.87 and was able to discriminate differences in physical activity levels between groups
differentiated by sex, age and fall risk factors. Total time spent is summed across all
components and expressed as hours per week. The score is derived from multiplying frequency
score and duration score to create a total duration for the week score.
Statistical and analytical plans Demographic and clinical data, falls, FoF scores and
(IPEQ-WA) scores will be reported using descriptive statistics. Paired t-test will be used to
compared the differences in FoF scores, number of falls and IPEQ-WA scores pre and post
intervention. Independent t-test will be used to compare differences in FoF score, number of
falls and IPEQ-WA scores in intervention group and comparator group at 3 months and 6 months
post intervention.
Ethical considerations Informed Consent Attending healthcare professionals will refer
eligible participants to members of the study team on the day of the clinic visit. Trained
study team members proficient in potential participants' language will explain the study and
clarify any doubts using the Participant Information Sheet. Participants will be given the
information sheet about the research study and informed that they could withdraw from the
study anytime. The contact details of the PI and DSRB would be given to them to allow them to
raise any queries regarding the study.
Potential participants will be given adequate time to consider before making a decision
whether or not to participate. If the individual fulfils the inclusion criteria and agrees
for research participation, written consent will be taken.
Confidentiality of Data and Patient Records Hard copy data will be stored in designated
locked cabinet(s) or room(s). Electronic data will be stored in a secured computer that is
password protected. All hard copy or electronic data will be accessible to authorized study
team members only.
