EVALUATION OF THE RISK OF FALLS IN THE ELDERLY POPULATION ABOVE 60 YEARS OF AGE

Active, not recruiting

Conditions: Risk of falls in older adults aged 60 years and above

Registration Number: CTRI/2022/10/046894

Lead Sponsor: Deepika Metange

Brief Summary: Fallsin older adults are multifactorial in origin with various internal and externalfactors leading to them. In India, there is no instrument for validatedassessment that can assess the risk of falls in the elderly in a simple and fast manner and consequently can be used in primary health care by professionals fromdifferent areas.

InIndia, with increasing urbanization, the urban and rural distinction iswidening at a faster pace. The cultural levels, living habits, physicalactivities, and environments of older adults in urban and rural areas are verydifferent. Hence the study aims to carry out research in two Phases. Phase I wewould recruit 1250 subjects. In this we would focus on identifying theprospective fall risk among older adults in urban and rural areas ofMaharashtra using clinical evaluative methods and understanding the variousrisk factors (e.g., age, gender, anthropometric measurements, exercise/physical activities, co-morbidities, depression, socio-economic status, use ofslippers/ walking aids, consumption of tobacco/ alcohol, use of medications,joint pains, ADL scores, joint pains etc.) contributing to the same. Thesubjects would be then categorized into high risk and low risk of falls basedon their scores on Quickscreen Fall Risk Assessment Scale. In phase II of thestudy, we would follow up 775 subjects from Phase I and aim to establish thediagnostic test properties of the Quickscreen Clinical Fall Risk AssessmentScale in order to establish the best cut-off scores among older adults. We alsoaim to study the incidence of falls by a 12-month follow-up study in order tosee that those at risk of falls actually have a fall or not in a 12-month timespan. We would also compare the intrinsic neurological factors (balance,mobility, autonomic dysfunction, reaction time etc.) of falls with older adultsat risk and not at risk of falls.

Wewill estimate the mean and standard deviation (SD), or median and interquartilerange (IQR) for continuous variables. We will estimate proportions forcategorical variables. The normality of the data will be assessedusing the Shapiro-Wilk test. The means will be comparedusing t-test for two groups or Analysis of Variance (ANOVA) for more than twogroups. The distribution for non-parametric data will be compared using theMann Whitney Wilcoxon test for two groups or the Kruskal Wallis test for morethan two groups. The proportions will be compared using the chi square test orFisherâ€™s exact test for low expected cell counts.

For Phase II we will estimate the sensitivity, specificity, positivepredictive value, and negative predictive value for prediction of falls in thispopulation. We will also use receiver operating characteristics (ROC) curve for identifying the optimal cut-off.A p value of < 0.05 will be considered statistically significant. Datawill be analyzed using Stata Version 17 (Â© StataCorp, College Station, Texas, USA).

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 1250

Inclusion Criteria

1.Older adults aged 60 years or over, of both sexes, who live in the community.
2.Older adults residing for at least six months in the area.

Exclusion Criteria

1.Any diagnosed neurological disorders viz.
Stroke, Multiple sclerosis, Parkinsonâ€™s disease, Alzheimerâ€™s disease.
2.History of orthopaedic disorders (fractures, severe arthritis) which may hinder participation in the tests.
3.Numbness in feet and legs (diabetic neuropathy), Vertigo etc.
4.Problems such as diabetic retinopathy, untreated cataract, glaucoma, macular degeneration, blindness etc.
5.Older adults with inability to communicate e.g., Aphasia, hearing deficits etc.
6.Presence of any known psychiatric conditions (mood disorders, schizophrenia) 7.Diagnosed with any acute medical illness, wheelchair bound or bed ridden.
8.Those residing in old age homes or any such institutions.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quickscreen Fall Risk assessment Scale	1 year

Secondary Outcome Measures

Name	Time	Method
1. Autonomic nervous system assessment using Compass 31 questionnaire	2. Montreal cognitive assessment (MOCA)

Trial Locations

Locations (1): Terna
🇮🇳
(Suburban), MAHARASHTRA, India
Terna
🇮🇳(Suburban), MAHARASHTRA, India
Deepika Metange
Principal investigator
9969492915
deepikapuri12@gmail.com