| CTRI Number |
CTRI/2024/05/067037 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Psychiatric Illnesses in elderly single |
|
Scientific Title of Study
|
Study of frequency and pattern of psychiatric illnesses in elderly single seeking treatment from psychiatry OPD or indoor at tertiary hospital. |
| Trial Acronym |
Fppies |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Karankumar Kirtibhai |
| Designation |
First year Resident |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
303,Doctor Quarter, E Block, Opposite A devision Police Station, Sir T Hospital,Bhavnagar
303,Doctor Quarter, E Block, Opposite A devision Police Station, Sir T Hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9016304135 |
| Fax |
|
| Email |
kkpatel1197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Patel |
| Designation |
Additional Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
402, om plaza, near ram mantra hospital, Bhavnagar
402, om plaza, near ram mantra hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9376623322 |
| Fax |
|
| Email |
dr.mkpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Patel |
| Designation |
Additional Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
402, om plaza, near ram mantra hospital, Bhavnagar
402, om plaza, near ram mantra hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9376623322 |
| Fax |
|
| Email |
dr.mkpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Patel Karankumar Kirtibhai |
| Address |
303,Doctor Quarter, E Block, Opposite A devision Police Station, Sir T Hospital,Bhavnagar |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrMukesh Patel |
402, om plaza, near ram mantra hospital, Bhavnagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karan patel |
Sir T Hospital, Bhavnagar |
psychiatry department
Bhavnagar
GUJARAT |
9016304135
kkpatel1197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICSCOMMITEEGOVERNMENTMEDICALCOLLEGEBHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F22||Delusional disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To Compare Psychiatry illnesses in Different Single Elderly Status |
To Compare Psychiatry illnesses in Different Single Elderly Status who are either
Divorced
Separated
Widow/Widower
Unmarried
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All single elderly patients who are divorced, separated, unmarried, widowed
All patients age group more than 60 year
All elderly single living alone/ with family/ elderly home
|
|
| ExclusionCriteria |
| Details |
Patient in Terminal Illness
Patient who are Uncooperative/ Unconsentive
Patient with Severe Cognitive Impairmen |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Results to find out in different psychiatry illnesses which one common in different single status |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="274"
Sample Size from India="274"
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)
|
18/05/2024 |
| 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="1"
Days="3" |
|
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
|
DSM 5 criteria apply for estimating frequency and pattern psychiatry illnesses in different single status |