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CTRI Number  CTRI/2023/11/060181 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 22/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Prevention of Dementia in Older Adults- Tiruvalla Interventional Study in Ageing 
Scientific Title of Study   "Mild Cognitive Impairment among Community DwellingAdults: Prevalence, Associated Factors, and Feasibility of a Multidomain Intervention Package for Preventing Cognitive Decline." 
Trial Acronym  PILOT STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saritha Susan Vargese 
Designation  Associate Professor, Community Medicine Believers Church Medical College Hospital, Tiruvalla 
Affiliation  Associate Professor, Community Medicine believers Church Medical College Hospital, Tiruvalla 
Address  Associate Professor Community Medicine Believers Church Medical College Hospital, Tiruvalla
Associate Professor Community Medicine believers Church Medical College Hospital, Tiruvalla
Pathanamthitta
KERALA
689103
India 
Phone  9544341959  
Fax    
Email  sarithasusan@bcmch.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Saritha Susan Vargese 
Designation  Associate professor, Community Medicine Believers Church Medical College Hospital, Tiruvalla 
Affiliation  Associate Professor, Community Medicine Believers Church Medical College Hospital, Tiruvalla 
Address  Associate Professor Community Medicine Believers Church Medical College Hospital, Tiruvalla
Associate Professor Community Medicine Believers Church Medical College Hospital, Tiruvalla
Pathanamthitta
KERALA
689103
India 
Phone  9544341959  
Fax    
Email  sarithasusan@bcmch.edu.in  
 
Details of Contact Person
Public Query  
Name  Saritha Susan Vargese 
Designation  Associate Professor, Community Medicine Believers Church Medical College Hospital, Tiruvalla 
Affiliation  Associate Professor, Community Medicine Believers Church Medical College Hospital, Tiruvalla 
Address  Associate Professor Community Medicine Believers Church Medical College Hospital, Tiruvalla
Associate Professor Community Medicine Believers Church Medical College Hospital, Tiruvalla
Pathanamthitta
KERALA
689103
India 
Phone  9544341959  
Fax    
Email  sarithasusan@bcmch.edu.in  
 
Source of Monetary or Material Support  
Indian Council Of medical Research Division of Non Communicable Diseases ICMR Hqrs, New Delhi-110029 
 
Primary Sponsor  
Name  NIH 
Address  Fogarty International Centre, Psychiatric Research Infrastructure for Intervention and Implementation in India, University of Pittsburgh, United States 
Type of Sponsor  Research institution 
 
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 
Dr Saritha Susan Vargese  Believers Church Medical College Hospital  Dept of Community Medicine, BCMCH, Tiruvalla, Pathanmathitta
Pathanamthitta
KERALA 		 9544341959

sarithasusan@bcmch.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Believers Church Medical College Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Life style modification advice  One time advice on life style modification including diet, exercise, vascular risk factors, habits at the baseline 
Intervention  Multidomain intervention   Duration - two years Nutritional guidance: The intervention package will begin with nutritional guidance based on National Institute of Nutrition guidelines 2020. Once in a Month session for 2 years Social support and engagement: Importance of health ageing will be emphasized through awareness sessions by doctors and veterans.Once in a month for two years Psychologists will conduct sessions to enable the intervention group to have healthy behavior, meaningful cross-age relationships and coping mechanism to improve their quality of life. Cognitive stimulation therapy - twice weekly for 7 weeks and then weekly for 24 weeks. Physical activity: Training will be managed by study physiotherapists and will consist of individually tailored programmes for progressive muscle strength training (1–3 times per week) and aerobic exercise (2–5 times per week), also covering exercises to improve postural balance. Mentored individual and group sessions once in a month. Individuals will be advised individual exercises to be carried out at home. Cognitive training: Cognitive stimulation therapy is an evidence-based intervention which will be implemented twice weekly for seven weeks following a diagnosis of mild to moderate dementia. Maintenance Cognitive Stimulation Therapy (MCST) requires weekly 1-2 hour sessions for people living with mild to moderate dementia. The participants will involve in meaningful and stimulating activities, which are established as strategies to maintain memory and mental functioning. The Activities include discussions, word games, quizzes, physical activities, creative and musical activities which will in add Management of metabolic and vascular risk factors: Once a month medical check up by qualified doctors. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals between 60-75 years old, willing to participate and comply with all the study evaluation and intervention procedures
CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of 6 points or higher
Mini Mental State Examination, MMSE <26 and >20
 
 
ExclusionCriteria 
Details  Barthel index < 90.
Geriatric Depression Scale ≥ 9
Dementia or Moderate Cognitive impairment (MMSE < 20).
Disorders that may affect safe involvement in the intervention (eg, malignancy, symptomatic cardiovascular disease, Large vessel stroke in the past two years, History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months, revascularisation within 1 year previously, severe loss of vision, hearing, or communicative ability)
Coincident participation in another intervention trial.
Recent (< 3 months) bone fracture.
History of hip fracture, joint replacement, or spinal surgery in the last 6 months
Clinically significant abnormalities in laboratory blood tests as per the judgment of the site study clinician.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cognitive ability will be assessed using Addenbrookes cognitive examination  Cognitive ability will be assessed at baseline, 6 months, 12 months and 24 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Depresiion, quality of life , ADL 
measurements will be made at baseline, 12 months & 24 months 
 
Target Sample Size   Total Sample Size="420"
Sample Size from India="420" 
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   N/A 
Date of First Enrollment (India)   25/12/2023 
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="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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

  3. Who will be able to view these files?
    Response - Anyone

  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 - Data are available indefinitely at (Link to be included saritha.vargese@gmail.com).

  6. For how long will this data be available start date provided 07-11-2023 and end date provided 07-11-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Study population: Older adults, 60-75 years of age with mild cognitive impairment.

Study sample: Randomly selected older adults, in the age group of 60-75 years with mild cognitive impairment in Tiruvalla taluk of Pathanamthitta district in Kerala.

Sample size:   

Various studies reported a difference of 0.01 to 0.03 in Z scores between the intervention and control group with standard deviation 0.002 to 0.042 (3-4). Also, their sample size ranges from 165 to 600. Therefore, we calculated the sample size for the present study using the parameters, difference in mean z -score as 0.01 and standard deviation 0.03 for a 90 % power and 5% type 1 error. We used the sample size formula to calculate the sample size for the difference in mean. We calculated the sample size as 189 and an expected possibility of 10% drop out. Based on this, we decided to enroll 210 as minimum required participants in our study in each arm.

Sampling procedure:

 Our sampling area consists of 54 wards  from Tiruvalla Taluk of Pathanamthitta district. From these wards, 15 urban and 5 (total 20 wards) ruralwards will be randomly picked. Identified, consented adults (60 to 75 year old) will be screened using the study tool and classify them according to the various levels (mild, moderate, severe) of cognitive impairment, lead to the burden assessment as an initial phase of the study. We randomly divide the selected 20 wards in to 10 each, say A and B and the flipped coin will decide which one is intervention and control group. Further, those diagnosed as Mild Cognitive Impairment (MCI), 21 each will be randomly enrolled into the study.     

 
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