| CTRI Number |
CTRI/2024/12/077944 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Life and its associated factors among Geriatric population in Haldwani block of Nainital District- A Community based Study |
|
Scientific Title of Study
|
Quality of Life and factors associated with it among Geriatric population in Haldwani block of Nainital District- A Community based Analytical 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 |
Ishaan |
| Designation |
PG Resident |
| Affiliation |
Government Medical College Haldwani |
| Address |
Department of Community Medicine
Government Medical College
Haldwani Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
8570800456 |
| Fax |
|
| Email |
drishaanvirmani1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sadhana Awasthi |
| Designation |
Professor & Head |
| Affiliation |
Government Medical College Haldwani |
| Address |
Department of Community Medicine
Government Medical College
Haldwani Uttarakhand
UTTARANCHAL
263139
India |
| Phone |
8570800456 |
| Fax |
|
| Email |
drsadhna1810@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ishaan |
| Designation |
PG Resident |
| Affiliation |
Government Medical College Haldwani |
| Address |
Department of Community Medicine
Government Medical College
Haldwani Uttarakhand
UTTARANCHAL
263139
India |
| Phone |
8570800456 |
| Fax |
|
| Email |
drishaanvirmani1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Rampur Road, Haldwani, Dist. Nainital, Uttarakhand 263139, India |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Haldwani |
| Address |
Government Medical College, Rampur Road, Haldwani, Nainital, Uttarakhand 263139 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishaan |
Rural Health Training Centre |
OPD Room, Rural Health Training Centre, Department of Community Medicine, Motahaldu, Haldwani, Dist. Nainital, Uttarakhand 263139
Nainital
UTTARANCHAL |
8570800456
drishaanvirmani1997@gmail.com |
| Dr Ishaan |
Urban Health Training Centre |
OPD Room, Urban Health Training Centre, Department of Community Medicine, Pollysheet, Haldwani, Dist. Nainital, Uttarakhand 263139
Nainital
UTTARANCHAL |
8570800456
drishaanvirmani1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric Quality of Life Screening |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The participants with age 60 years and above and are the permanent resident of the area(under the study) since last 5 years.
|
|
| ExclusionCriteria |
| Details |
the participants who do not consent to participate in the research study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life of Geriatric Participants |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors associated with Quality of Life |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="610"
Sample Size from India="610"
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)
|
21/12/2024 |
| 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="0"
Months="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
The participants would be
enrolled from rural and urban field practice areas of Department of Community
Medicine, Government Medical College, Haldwani. Stratified Random Sampling (at
the level of urban and rural field practice areas) will be done for the enrolment, the written informed consent would be taken at the time of enrolment. |