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CTRI Number  CTRI/2022/04/041975 [Registered on: 20/04/2022] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Process of Care Changes
Behavioral 
Study Design  Other 
Public Title of Study   A Study on risk factors of fall and effectiveness of need based program on fall prevention behavior and Activities of Daily Living among elderly in a selected community, New Delhi 
Scientific Title of Study   A Study on risk factors of fall and effectiveness of need based program on fall prevention behavior and Activities of Daily Living among elderly in a selected community, New Delhi 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika kankarwal 
Designation  PhD. scholar 
Affiliation  Himalayan college of Nursing, Swami Rama Himalayan University, Dehradun 
Address  Himalayan college of nursing, Swami Rama Himalayan university, Dehradun,uttrakhand-248016

Dehradun
UTTARANCHAL
248016
India 
Phone  8287800751  
Fax    
Email  monikakankarwal25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamli Prakash 
Designation  Professor 
Affiliation  Himalyan College of Nursing,Swami Rama Himalayan University, Dehradun 
Address  Himalayan College of Nursing, SRHU, Dehradun

Dehradun
UTTARANCHAL
248016
India 
Phone  9458137789  
Fax    
Email  kamliprakash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Monika kankarwal 
Designation  PhD. scholar 
Affiliation  Himalayan college of Nursing, Swami Rama Himalayan University, Dehardun 
Address  Himalayan college of nursing, swami rama himalayan university, dehradun, uttrakhand-248016

Dehradun
UTTARANCHAL
248016
India 
Phone  8287800751  
Fax    
Email  monikakankarwal25@gmail.com  
 
Source of Monetary or Material Support  
Himalayan College of Nursing, SRHU, DEHRADUN 
 
Primary Sponsor  
Name  SRHU DEHRADUN 
Address  Himalayan College of Nursing, SRHU, DEHRADUN 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Monika kankarwal  SRHU, DEHRADUN  Himalayan College of Nursing, SRHU
North East
DELHI 		 8287800751

monikakankarwal25@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Swami Rama Himalayan University  Approved 
Swami Rama Himalayan University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Elderly 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  need based fall prevention program for elderly  It will be 3 weeks need based program on fall prevention behaviour and activities of daily living for elderly which will be administered every alternate day in a week up-to 3 weeks including- 1. Exercises training for balance and muscle strengthening, 2. Home hazards modifications, 3. Education on modification of fall risk behaviour, 4. Active ageing, 5. Demonstration on proper use of assistive devices.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elderly aged 60 years or more and consenting to be part of the study will be included under the study.
-Ability to understand Hindi or English.
 
 
ExclusionCriteria 
Details  Elderly who refuse/ withdraw consent from the study.
2. Elderly who are bedridden, severely disabled, having neurological and psychiatric problem, recently fractured bone, having H/o dizziness and syncope in youth, unable to participate and communicate.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
fall rates, Fall prevention behaviour and Activities of daily living for Elderly  at 3 months, 6 months and 1 year from intervention administration 
 
Secondary Outcome  
Outcome  TimePoints 
fall rate  3 month, 6 months and at 1 year 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2022 
Date of Study Completion (India) 12/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/01/2024 
Estimated Duration of Trial   Years="2"
Months="1"
Days="29" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. Kankarwal. M, Prakash K, Falls are preventable: A multicomponent falls preventive approach for elderly. 2022;18(4):227-232. 2. “Look My Old age”, Poetry in Geriatrics, Accepted in Indian journal of Geriatric Academy, jiag_48_23_R2_LTE 3. Abstract published in Journal of the Indian Academy of Geriatrics on topic, “Kankarwal M, Prakash K, Kumar S, A study to assess various risk factors associated with falls among older persons residing in a selected community, New Delhi. Journal of the Indian Academy of Geriatrics, 2023;19(3):184”. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Population aging is transforming the world in dramatic and fundamental ways, and it presents tremendous challenges to the field of medicine. Elderly population face numerous social and cultural changes and problems which are taking place inside the Indian society. Falls are contemplated as “Geriatric Giants. According to secondary review of literature conducted on RCTs regarding fall prevention among elderly in Asia, suggested for focussing on the need of high quality and accurately powered fall prevention program among elderly at local context level. A culturally appropriate intervention with more researches focusses on multifactorial and multidisciplinary fall prevention program at local context level in India, is much needed. Falls cause considerable mortality and morbidity among older adults. With the increase in life expectancy, it is likely that there will be a rise in the incidence of falls and with it, a greater need for awareness, education, and resource allocation in this area is required. Nurses being leading from the front in management of falls, a nurse lead intervention for fall prevention will be more useful in clinical as well as community settings.
 Widely implementing need based fall prevention programme based at comunity level is essential to decrease health  cost related to injuries caused by fall to elderly and will also heightened awareness, education, resource allocation , assertiveness and provide ready to use set guideline for society, government,  geriatricians, physicians, nurses, students,  family care givers and older adults that will help them to take all necessary measure in prevention of fall among senior citizen at primary level itself.

  
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