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CTRI Number  CTRI/2024/04/066448 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Measures to Prevent Falls in Elderly People in Kerala, India 
Scientific Title of Study   Interventions for prevention of falls among older persons - a randomized control trial in Kerala, India 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NiL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rekha M Ravindran 
Designation  Medical Superintendent 
Affiliation  Government District Hospital Nedumangaud 
Address  Superintendent Office, Government District Hospital Nedumangaud, Hospital road, Pazhavadi, Nedumangaud, Kerala
Superintendent Office, Government District Hospital, Nedumangaud, Hospital Road, Pazhavadi, Nedumangaud, Thiruvananthapuram, Kerala - 695541, India
Thiruvananthapuram
KERALA
695541
India 
Phone  919400330847  
Fax    
Email  devsuneel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Prasad Varma P 
Designation  Additional Professor 
Affiliation  AMCHSS, SCTIMST, Trivandrum 
Address  Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Medical College Campus, Thiruvananthapuram, Kerala
Department of Public Health, Second Floor, Room No. 8, Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Thiruvananthapuram
KERALA
695011
India 
Phone  919400570835  
Fax    
Email  dr.rpvarma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aravind Chandru B 
Designation  Research Officer 
Affiliation  SHSRC-K 
Address  Research wing, Second Floor, Room No.17, State Health Systems Resource Centre Kerala, KSIHF Campus, Thycaud, Thiruvananthapuram, Kerala
Research wing, Second Floor, Room No.17, State Health Systems Resource Centre Kerala, KSIHF Campus, Thycaud, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695014
India 
Phone  919496834233  
Fax    
Email  rvndchandrupamc@gmail.com  
 
Source of Monetary or Material Support  
National Health Mission, Arogya Keralam, Office of the Mission Director, NRHM Building,General Hospital Junction, Thiruvananthapuram 695035, Kerala 
 
Primary Sponsor  
Name  National Health Mission Central 
Address  National Health Mission 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rekha M Ravindran  Government District Hospital Nedumangad, Thiruvananthapuram, Kerala  Government District Hospital Nedumangad, Hospital road, Pazhavadi, Nedumangad, Thiruvananthapuram, Kerala - 695541, India
Thiruvananthapuram
KERALA 		 9400330847

thqhndd@gmail.com 
Dr Rekha T R  Government District Hospital Ottupara  Government District Hospital Ottupara, Kodungallur - Shornur Rd, Ottupara, Wadackanchery, Thrissur, Kerala, 680590, India
Thrissur
KERALA 		 9447380688

thqhwky@yahoo.com 
Dr Taj Paul Panakkal  Government General Hospital Thrissur   Governemnt General Hospital, Palakkal Angadi Road, High Rd, near Josco Jewellers, Thrissur, Kerala 680001
Thrissur
KERALA 		 9847031197

ghthrissur.hlth@kerala.gov.in 
Dr Divya Sadasivan  Government General Hospital, Thiruvananthapuram, Kerala  Government General Hospital, Kunnukuzhi PO, Thycud, Thiruvananthapuram, Kerala - 35
Thiruvananthapuram
KERALA 		 9400489862

divyasadasivan74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
State Health Systems Resource Centre-Kerala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine check-ups and IEC Booklet  Routine check-ups: participants will be asked to continue their monthly hospital visits. IEC Booklet: provided to all participants at the time of the baseline survey. 
Intervention  Routine check-ups, Exercise, IEC Booklet, and Home Modification advice   Routine check-ups:participants will be asked to continue their monthly hospital check-ups. Exercise interventions are divided into a basic and comprehensive package. Those able to practice basic sets will be given the comprehensive package. For the first 6 months, group interventions will be conducted in hospital settings (twice a month, 12 visits in total). Advised to practice exercises six days a week. IEC booklet containing details of fall prevention strategies (nutrition, home environment, NCDs and morbidities, medication reviews, and carer information) will be provided on the first day of group intervention to all participants. Home modification advice: A grass-roots health care provider (ASHAs/Palliative Unit) will visit the homes of participants once every two months and will assess the home environment for fall risk and provide advice for modification. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All willing ambulatory community-dwelling older adults (60 years and older) attending the NCD/geriatric clinics of selected secondary care units with moderate to high risk for falls (screened using a fall risk assessment tool) will be the participants of this study.  
 
ExclusionCriteria 
Details  Individuals who are hospitalised or ailing with acute injuries causing fractures or immobility at the time of data collection will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the incidence of falls or risk for falls will be the primary outcome.   At baseline, 6 months and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the body balance, muscle strength, Activities of Daily Living (ADL) and cognitive function will be considered as secondary outcomes.  Compared with the start of the trial to the six-month and 12-month data. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals and requests for the data should be directed to rvndchandrupamc@gmail.com. To gain access, data requestors will need to sign a data access agreement.

  6. For how long will this data be available start date provided 11-12-2025 and end date provided 11-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The main aim of the trial is to develop feasible interventions for the prevention of falls among older persons in Kerala.

The specific objectives include:

To examine whether a multifactorial fall prevention programme comprising education on falls, lifestyle advice, medication reviews, exercise intervention, and recommendations for environmental adaptation can reduce the incidence of falls and reduce the risk of falls among community-dwelling older persons when compared to conventional care, including education on falls and lifestyle advice.

The study will be conducted among community-dwelling older persons (60 years of age and older) attending outpatient departments in selected geriatric clinics.

All the participants will be assessed during the baseline, at six months, and at the end of one year. Information about the participant’s health and lifestyle (level of physical activity, alcohol use, smoking, and diet) will be ascertained. Body balance and gait will be assessed using a modified POMA scale and grip strength will be examined using a digital dynamometer. Activities of daily living and cognition will also be assessed using the ADL scale and the MoCA scale, respectively. Incident interviews will be conducted with participants who report falls or critical incidents during the study period. A sub-sample of the participants and service providers will be interviewed to explore their perspectives and experiences as part of the study.

 

 
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