CTRI Number |
CTRI/2022/12/048184 [Registered on: 16/12/2022] Trial Registered Prospectively |
Last Modified On: |
19/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Awareness about the risk of falls in older people. |
Scientific Title of Study
|
Public Awareness of Fall Risk in Elderly |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prince Rohilla |
Designation |
Post Graduate Student |
Affiliation |
Amar Jyoti Institue of Physiotherapy |
Address |
Amar Jyoti Institute of Physiotherapy, Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.
East DELHI 110092 India |
Phone |
9953872140 |
Fax |
|
Email |
princephysio98@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sampada Jahagirdar |
Designation |
Assistant Professor |
Affiliation |
Amar Jyoti Institute of Physiotherapy |
Address |
Amar Jyoti Institute of Physiotherapy, Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.
East DELHI 110092 India |
Phone |
9810991128 |
Fax |
|
Email |
s.jahagirdar@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Sampada Jahagirdar |
Designation |
Assistant Professor |
Affiliation |
Amar Jyoti Institute of Physiotherapy |
Address |
Amar Jyoti Institute of Physiotherapy, Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi.
East DELHI 110092 India |
Phone |
9810991128 |
Fax |
|
Email |
s.jahagirdar@yahoo.co.in |
|
Source of Monetary or Material Support
|
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, East Delhi, New Delhi-92 |
|
Primary Sponsor
|
Name |
Prince Rohilla |
Address |
B 26, Saraswati Kunj, Najafgarh, South West, New Delhi-110072 |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Prince Rohilla |
Amar Jyoti Institute of Physiotherapy |
Neurology Lab, Third Floor, Vikas Marg, Karkardooma, East Delhi, New Delhi. East DELHI |
9953872140
princephysio98@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Amar Jyoti Institutional Review Board- Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy Individuals are participants |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
PHASE 1: Development of Questionnaire
1 (a) For Questionnaire Validation:
The professionals from the field of geriatric rehabilitation working closely with older adults for a minimum of 5 years which includes Doctors (experienced in Geriatric Medicine), Physiotherapists working in academic and clinical institutions, Sociologist, and Psychologist.
1 (b) For Internal consistency:
Adults aged 18 years and above
Able to understand Hindi or English.
PHASE 2: Evaluation of Public Awareness Regarding Risk Factors of Fall in Elderly
Community living adults aged 18 years and above.
Ability to understand Hindi or English |
|
ExclusionCriteria |
Details |
PHASE 1: Development of Questionnaire
1 (a). All excluded except inclusion criterion
1 (b). The professionals from the field of geriatric rehabilitation working closely with older adults.
PHASE 2: Evaluation of Public Awareness Regarding Risk Factors of Fall in Elderly
The professionals from the field of geriatric rehabilitation working closely with older adults.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Responses to Questionnaire
|
One Time |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="384" Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "394"
Final Enrollment numbers achieved (India)="394" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
30/12/2022 |
Date of Study Completion (India) |
30/09/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
30/09/2023 |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Brief Introduction According to WHO, there are several risk factors listed due to which the majority of falls occur. These risk factors can be classified into Intrinsic and extrinsic factors. Intrinsic risk factors include age, gender, ethnicity, living alone, medicines, medical condition, impaired mobility, sedentary lifestyle, psychological status, nutritional deficiencies, impaired cognition, visual impairments, foot problems etc. Extrinsic include environmental hazards (poor lighting, slippery floors, uneven surfaces, etc.), footwear and clothing, inappropriate walking aids or assistive devices. (Todd & Skelton 2004) As prevention is better than cure, falls can be prevented by strategies aiming to modify these risk factors. Some risk factors are modifiable, especially extrinsic. We can modify them only when we know about them. It is our responsibility as a society to make our environment conducive to people of all ages. Thus, it is important that not only the old but even young people should know about the risk factors of falls that can be managed. Purpose of the Study Till date, there is no study that gives information on the knowledge of the general population regarding the risk factors of falls among the elderly. This study is needed to assess and analyze the awareness of the general population on the topic. The knowledge gained from this study will enable us to direct appropriate actions and interventions as needed for the pursuit of creating a safe and secure environment for our older generation. Research Question (As Hypothesis is not applicable) What is the level of awareness of fall risks of the Indian elderly among the general population? |