| CTRI Number |
CTRI/2019/04/018363 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of life in elderly in rural area of Delhi |
|
Scientific Title of Study
|
STUDY ON QUALITY OF LIFE AND ASSOCIATED FACTORS IN ELDERLY IN A RURAL AREA OF DELHI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine
Third Floor
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9540723873 |
| Fax |
|
| Email |
ankitxyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajendra Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 322,Department of Community Medicine
Third Floor
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9968604243 |
| Fax |
|
| Email |
gajendrasm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankit Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine
Third Floor
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9540723873 |
| Fax |
|
| Email |
ankitxyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3rd Floor, Department of Community Medicine, Pathology block, Maulana Azad Medical College, Bahadur Shah Zafar road, New Delhi-110002. |
|
|
Primary Sponsor
|
| Name |
Dr Ankit yadav |
| Address |
Department of Community Medicine
Third Floor
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Ankit Yadav |
Maulana Azad Medical College |
Room no 322, IIIrd floor, Department Of Community Medicine, Pathology block
Central
DELHI |
9540723873
ankitxyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Quality of life ans associated factors |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All persons aged sixty years and above
Those who are resident of the study area for at least past 6 months
|
|
| ExclusionCriteria |
| Details |
Individuals who are severely ill, debilitated or unable to communicate.
Individuals who will not be available after 3 visits/contacts.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean WHOQOL-BREF score in elderly people of a rural area of the Delhi |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of disease in elderly people in the study area.
2. Socio-economic status of elderly in the study area. |
one year |
|
|
Target Sample Size
|
Total Sample Size="189"
Sample Size from India="189"
Final Enrollment numbers achieved (Total)= "195"
Final Enrollment numbers achieved (India)="195" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
31/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. This Study is being conducted to study the quality of life in elderly aged sixty years and above using WHOQOL-BREF in a rural area of Delhi and to assess sociodemographic factors and self-reported co-morbidities with quality of life. |