| CTRI Number |
CTRI/2025/02/080964 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Modifiable Risk Factors for Dementia among Middle-Aged in Dakshina Kannada |
|
Scientific Title of Study
|
Prevalence of Modifiable Risk Factors for Dementia among Middle-Aged People in Dakshina Kannada: A Cross-Sectional Study |
| 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 Sherley Immaculate DAlmeida |
| Designation |
Post Graduate Student |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
Department of Public Health, K.S.Hegde Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8951512651 |
| Fax |
|
| Email |
sherleydalmeida@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mackwin Dmello |
| Designation |
Associate Professor |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
Department of Public Health, K.S.Hegde Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mackwin Dmello |
| Designation |
Associate Professor |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
Department of Public Health, K.S.Hegde Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Department of Public Health, K.S.Hegde Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
|
|
Primary Sponsor
|
| Name |
Dr Sherley Immaculate DAlmeida |
| Address |
Department of Public Health, K S Hegde Medical Academy, Deralakatte, Mangaluru - 575018 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| Dr Sherley DAlmeida |
K.S.Hegde Medical Academy |
Department of Public Health, Deralakatte post, Nithyananda nagar, Mangalore - 575018
Dakshina Kannada
KARNATAKA |
8951512651
sherleydalmeida@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of K.S.Hegde Medical Academy, Nitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Women and Men aged between 45 and 65 years who are verbally able to communicate
|
|
| ExclusionCriteria |
| Details |
people with Psychiatric disabilities and people who are Diagnosed with any Dementia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of modifiable risk factors for dementia |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The association of modifiable risk factors for dementia & cognitive impairment score |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="1755"
Sample Size from India="1755"
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)
|
03/03/2025 |
| 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="2"
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
|
This is a descriptive cross-sectional study which will be conducted in the Rural and Urban areas of Dakshina Kannada, with a sample size of 1755. This study aims to determine the prevalence of the modifiable risk factors for dementia among the people of age group 45-65 years and to determine the cognitive impairment of these individuals using Addenbrookes cognitive examination questionnaire and to find the association of modifiable risk factors for dementia and cognitive impairment score. A mobile based application (Epicollect5) and paper forms will gather data. Informed consent will be obtained before participation. Data analysis will be done using statistical Software SPSS version 29 or Jamovi software version 2.3.28. Categorical data will be expressed as frequency and percentage. Quantitative data will be expressed as mean or median. The chi-square test or fischers exact test will be used to find the association between modifiable risk factors and cognitive impairment score. p value <0.05 will be considered statistically significant. |