| CTRI Number |
CTRI/2024/01/061172 [Registered on: 06/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [cohort multiple randomised controlled trial] |
| Study Design |
Other |
|
Public Title of Study
|
Prevention of Dementia in elderly Indians (SMRUTHI-INDIA) |
|
Scientific Title of Study
|
Strategic Multimodal Intervention in at-risk elderly Indians for Prevention of Dementia (SMRUTHI-INDIA): A cohort multiple randomised controlled trial (cmRCT) |
| Trial Acronym |
SMRUTHI-INDIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnu V Y |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
RN 704, Seventh floor
CN Centre
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9855480361 |
| Fax |
|
| Email |
vishnuvy16@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishnu VY |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
RN 704, CN Centre
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9855480361 |
| Fax |
|
| Email |
vishnuvy16@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishnu VY |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
RN 704, CN Centre
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9855480361 |
| Fax |
|
| Email |
vishnuvy16@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research,ICMR,MOHFW, ICMR |
|
|
Primary Sponsor
|
| Name |
Department of Health Research,ICMR,MOHFW, ICMR |
| Address |
1, Red Cross Road,New Delhi,Delhi, Gokul Nagar, Sansad Marg Area, New Delhi, Delhi 110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishnu VY |
AIIMS New Delhi |
RN 701, CN CENTRE
AIIMS New Delhi
South
DELHI |
9855480361
vishnuvy16@yahoo.com |
| Sunil Raina |
MRHRU Haroli, Himachal Pradesh |
MRHRU, Near Civil hospital
Harold, Una, Himachal Pradesh
Una
HIMACHAL PRADESH |
9418061066
ojasrainasunil@yahoo.co.in |
| Praveen Kumar |
MRHRU Jaipur |
MRHRU Khanpur
Kalan, Jaipur- 302046
Jaipur
RAJASTHAN |
9251501461
ananddmrcjodhpur@gmail.com |
| Subarna Roy |
MRHRU Sirwar |
Room no 12, ground floor
MRHRU, PHC CAMPUS, Sirwar District, Raichur, Karnataka
Raichur
KARNATAKA |
9449033133
drsubarnaroy@gmail.com |
| Subrata Baidya |
MRHRU Tripura Khumulwng |
MRHRU Near Kherengbar, CHC
Khumulwng, Madhapur, Tripura-799045
West Tripura
TRIPURA |
9436122899
drsubratabaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institute Ethics committee for clinical studies, government medical college Agartala |
Approved |
| Institute Ethics committee, AIIMS New Delhi |
Approved |
| Institute ethics committee, Dr.RPGMC Tanda |
Approved |
| Institutional ethics committee, ICMR NIIRNCD |
Approved |
| nstitutional Human Ethics Committee ICMR-NITM Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitively normal but at future risk for developing dementia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal care bundle |
Multimodal care bundle constitutes of regular monitoring of vascular risk factors, culturally appropriate nutritional guidance, physical exercise/yoga, and psychoeducation for deaddiction
Frequency is Daily monitoring for a duration of 1 year |
| Comparator Agent |
Standard of care |
Standard of care |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 55 years
2. Permanent resident of the defined area
3. CAIDE (Cardiovascular Risk Factors Aging and Dementia) Risk Score of 6 points or higher
4. Absence of Dementia or MCI (DSM 5 criteria for major Neurocognitive Decline) after Neuropsychological evaluation
5. Consenting to participate and complete all study related activities for 5 years |
|
| ExclusionCriteria |
| Details |
1. Established Dementia
2. Disabling stroke or structural brain abnormality
3. Vision, hearing or communication impairment affecting NP testing
4. Psychiatric illness- major depressive disorder, psychosis
5. Significant medical illness like malignancy, end stage renal disease, decompensated liver disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of all cause probable dementia or mild cognitive impairment |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of mild cognitive impairment |
5 years |
| time to first occurrence of diagnosis of dementia |
5 years |
| time to first occurrence of diagnosis of MCI |
5 YEARS |
| Change in composite and domain Z scores |
5 years |
| Change in LIBRA Index |
5 years |
| Mortality |
5 years |
| Composite outcome of stroke, MI, MCI, Dementia |
5 years |
| Composite outcome of stroke and MI |
5 YEARS |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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)
|
15/01/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
SMRUTHI INDIA involves the establishment of a large well-defined cohort of healthy individuals aged ≥ 55 and having risk factors for dementia. We have envisaged a novel study design of “Cohort Multiple Randomised Controlled Trial†which combines a cohort study with in-built provisions to do multiple randomised controlled trials. The study design allows the conduct of multiple interventions in the cohort and it reduces the cost of implementation of these studies. Our study has two phases: Phase 1 will be the establishment of the cohort in 4 MRHRUs and the development of the multimodal care bundle with a feasibility study (pilot RCT). Phase 2 will be evaluation of this multimodal care bundle in a randomised controlled trial. The first intervention which we plan to implement (in phase 2 of the study) is a locally designed multimodal “care bundle†for the prevention of dementia which is culturally tailored and context-specific to the Indian population. This will be the first primary prevention strategy ever tested in a high-quality Randomised Controlled Trial in Asia. If proven to be efficacious, this multimodal care bundle can be integrated into the National Health Programmes. |