| CTRI Number |
CTRI/2017/03/008227 [Registered on: 27/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Needs testing for Occupational Therapy treatment in community living persons with schizophrenia |
|
Scientific Title of Study
|
Needs Assessment for Occupational Therapy Intervention in community dwelling persons with schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deena Dimple Dsouza |
| Designation |
Postgraduate student |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
Shalom, Near corporation Bank, Shivalli post, Perampalli Udupi
Department of Occupational therapy, SOAHS, Manipal University
Udupi
KARNATAKA
576102
India |
| Phone |
9663203862 |
| Fax |
|
| Email |
deenadimple@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinita Acharya |
| Designation |
Assistant Professor (Selection grade) |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Occupational therapy, SOAHS, Manipal University
Department of Occupational therapy, SOAHS, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9986071111 |
| Fax |
|
| Email |
vinita.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Deena Dimple Dsouza |
| Designation |
Postgraduate student |
| Affiliation |
School of Allied Health Sciences, Manipal |
| Address |
Shalom, Near corporation Bank, Shivalli post, Perampalli Udupi
Department of Occupational therapy, SOAHS, Manipal University
Udupi
KARNATAKA
576102
India |
| Phone |
9663203862 |
| Fax |
|
| Email |
deenadimple@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba Hospital
Department of psychiatry
Manipal |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 |
| Deena Dimple Dsouza |
kasturba Hospital |
3rd Floor,
Department of Psychiatry
Udupi
KARNATAKA |
9663203862
deenadimple@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC-KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
schizophrenia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with schizophrenia more than 2 years
living in the community at least 6 months from previous hospitalization |
|
| ExclusionCriteria |
| Details |
with co morbid conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
level of functioning
|
25th march 2017
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/01/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Schizophrenia is a severe mental condition affects the daily activities, social relationship, occupational functioning. Understanding and enabling participation in daily activities for persons experiencing difficulties is primary area of focus for occupational therapist. what is level of functioning and occupational therapy needs of community dwelling persons with schizophrenia ? Indian Disability Evaluation and Assessment Scale IDEAS will be administered and for selected clients in depth interview will conducted for clients and focus group for caregiver Transcribed interviews will be analyzed using thematic analysis
|