| CTRI Number |
CTRI/2025/07/090343 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To develop and validate a comprehensive caregivers guide for older adults with psychosis attending Geriatric Mental Health Unit of tertiary mental health care institute of North East region of India. |
|
Scientific Title of Study
|
Development And validation of a Comprehensive Caregivers Guide for Older Adults with Psychosis (CCG-OAP) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajusree Borah |
| Designation |
PHD SCHOLAR |
| Affiliation |
LGB Regional Institute of Mental Health (LGBRIMH), Tezpur |
| Address |
Department of Psychiatric Nursing, LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
8812972941 |
| Fax |
|
| Email |
kajusree05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunjyoti Baruah |
| Designation |
Professor and HOD |
| Affiliation |
LGB Regional Institute of Mental Health (LGBRIMH), Tezpur |
| Address |
Department of Psychiatric Nursing, LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
03712232942 |
| Fax |
|
| Email |
arunjyotibaruah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunjyoti Baruah |
| Designation |
Professor and HOD |
| Affiliation |
LGB Regional Institute of Mental Health (LGBRIMH), Tezpur |
| Address |
Department of Psychiatric Nursing, LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
03712232942 |
| Fax |
|
| Email |
arunjyotibaruah@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LGB Regional Institute of Mental Health, Tezpur, Assam |
|
|
Primary Sponsor
|
| Name |
Kajusree Borah |
| Address |
Department of psychiatric nursing, LGBRIMH, Tezpur, Assam, India
Pin- 784001 |
| 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 |
| Kajusree Borah |
LGB Regional Institute of Mental Health, Tezpur, Assam |
Room no-7, Department of Geriatric Mental Health Unit, both IPD and OPD.
Sonitpur
ASSAM |
8812972941
kajusree05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LGBRIMH Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
For older adults with psychosis
1. Older adults who are diagnosed with (F-20 to F39) which includes F20-29, F30.2, F31.2, F31.5, F32.3, F33.3 as per ICD 10 criteria.
For Caregiver
1. Caregivers of older adults who stay more than 1 year with the older adult admitted in LGBRIMH
2. Can speak and understand Assamese or English.
3. Caregivers who are willing to participant.
|
|
| ExclusionCriteria |
| Details |
For older adults with psychosis
1. Older adults who are diagnosed with dementia or other cognitive impairment.
For Caregivers
1. Paid caregiver
2. Caregiver with cognitive impairment
3. Caregiver currently receiving treatment for mental illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By doing case study needs, challenges, issues of caregiver and older adults will be found out. By Analyzing the findings which caregivers guide will be developed and validate. |
36 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
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)
|
31/07/2025 |
| 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="1"
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
|
BACKGROUND:Caring for older adult with mental health issue is a significant challenge. They require specialized care and support to manage the symptom. Older adult with psychosis requires caregivers to provide physical, emotional and psychological support. Research evidence found that there is research gap in terms of CCG-OAP. So, researcher felt theneed of in-depth exploration of the cases and understand the real- life experiences, challenges and issues faced by caregivers. With the help of the findings researcher will develop a comprehensive caregiver’s guide tailored to the needs of older adults with psychosis. Research evidence suggested the need to develop a caregivers guide to help them improve their knowledge, caregiver’s skill, gain confident and prepare the caregivers to care for the older adult with psychosis. AIM OF THE STUDY: The aim of the study is to develop and validate a comprehensive caregivers guide for older adults with psychosis (CCG-OAP) attending geriatric mental health unit of tertiary mental health care institute of North East region of India. METHODOLOGY: Qualitative research approach and Case study research design in two phases will be adopted for the proposed study. In Phase I, Case study data collection and analysis will be done. Sample of the study will be older adults and the caregivers of older adult with psychosis who visited LGBRIMH, Tezpur fulfilling the sample selection criteria which will be selected by using purposive sampling technique. Data will be collected by interview, observationand documentation from patient’s file. Informed consent will be taken from the participants after proper explanation and assurance for confidentiality and anonymity of data. The collected data will be analysed by Braun and Clarke thematic analysis method. In Phase II, Development of caregiver’s guide will be done based on understanding the needs, themes identified, scoping review and Focus group discussion. Developed care giver’s guide will be validated by experts and stakeholders following which CCG-OAP will be formulated. The CCG-OAP will be further translated and validated into vernacular language by following the steps of WHO. Key words- Caregiver, Caregiver’s guide, psychosis, older adult with psychosis. |