| CTRI Number |
CTRI/2015/09/006189 [Registered on: 15/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
06/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge and attitude of care givers regarding mental illness |
|
Scientific Title of Study
|
A study to assess the knowledge and attitude of care givers regarding affective disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Rani Rose Thomas |
| Designation |
PG Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Holy Queens Provincial House
Changanacherry PO
Kottayam
Kerala
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Kottayam
KERALA
686101
India |
| Phone |
9241141986 |
| Fax |
|
| Email |
srancy2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Agnes EJ |
| Designation |
HOD of Psychiatric Nursing |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050157831 |
| Fax |
|
| Email |
agnesej2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Agnes EJ |
| Designation |
HOD of Psychiatric Nursing |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8050157831 |
| Fax |
|
| Email |
agnesej2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital
Kankanady
Mangalore
575002 |
|
|
Primary Sponsor
|
| Name |
Ms Rani Rose Thomas Sr Ancilin |
| Address |
Holy Queens Provincial House
Changanacherry PO
Kottayam dist
Kerala
|
| Type of Sponsor |
Other [Self funded] |
|
|
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 Sanjeev Rai |
Father Muller Medical College Hospital |
Chief Medical Officer
Father Muller Medical College Hospital Mangalore
Dakshina Kannada
KARNATAKA |
9448133494
raibs11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy care givers of patients with affective disorders |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Care givers who stayed with patient after diagnosis for at least six months.
Care givers whose patients are diagnosed with manic episode, bipolar affective disorder, depressive episode, recurrent depressive disorder and persistent mood disorder.
Care givers who communicate either in English, Kannada or Malayalam.
Care givers in the age group of 21-60years.
|
|
| ExclusionCriteria |
| Details |
Care givers who are diagnosed with psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge gain |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Attitude |
Two Years |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/06/2013 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
People’s beliefs and attitudes towards mental illness set the stage for how they interact with, provide opportunities for, and help support a person. Attitudes and beliefs about mental illness are shaped by personal knowledge, knowing and interacting with someone living with mental illness, cultural stereotypes, and other factors. When such attitude and beliefs are expressed positively, they can result in sportive and inclusive behavior. When such attitudes and beliefs are expressed negatively, they may result in avoidance, exclusion from daily activities and in the worst case, exploitation and discrimination.
In India, families represent the key resource persons in the care of patients with chronic mental illness. Mental health services have moved away from providing institutional care to community based care. So family members have increasingly found themselves becoming primary source of care and social support for relatives of persons suffering from affective disorders. Family member’s poor or lack of knowledge and negative attitude towards affective disorders threatens the effectiveness of patient care and rehabilitation. This can inhibit the decision to seek help and provide proper holistic care. Better knowledge often reported to results in improved attitude towards people with mental illness and a belief that mental illness are treatable , can encourage early treatment seeking and promote better out come. Objectives · To determine relationship between knowledge and attitude of care giver of patients with affective disorders. · To determine the association of knowledge and attitude with selected baseline variables of care givers.
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