| CTRI Number |
CTRI/2020/07/026620 [Registered on: 16/07/2020] Trial Registered Prospectively |
| Last Modified On: |
10/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study with phenomenological approach |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the experiences of caregivers in managing daily occupations of people with dementia |
|
Scientific Title of Study
|
Exploring caregivers experiences in managing daily occupations of people with dementia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaushika V |
| Designation |
Post graduate student (MOT) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Kaushika V
Department of Occupational Therapy
Manipal College of Health Professions
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9600159127 |
| Fax |
|
| Email |
kaushika.v@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy
Manipal College of Health Professions
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8317394874 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy
Manipal College of Health Professions
Manipal
Karnataka
Hassan
KARNATAKA
576104
India |
| Phone |
8317394874 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kaushika V
Department of Occupational Therapy
Manipal College of Health Professions
Manipal
Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kaushika V |
| Address |
Department of Occupational Therapy
Manipal College of Health Professions
Madhav nagar
Manipal
Karnataka 576104
|
| 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 |
| Dr Sridhar V |
Schizophrenia Research Foundation |
Dementia care in SCARF
Mental Health Center
R 7A North main road
Anna nagar
Chennai
Tamilnadu 600101
Chennai
TAMIL NADU |
7358388822
sridhar.v@scarfindia.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturbha Medical College and Kasturbha Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary caregivers of people with dementia |
| Patients |
(1) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregiver who has care giving experience with the individual diagnosed with dementia in managing his or her occupations for the past one month at least.
Individual diagnosed with dementia.
Adequate comprehension and communication in English or Tamil
|
|
| ExclusionCriteria |
| Details |
Paid caregivers.
Participants diagnosed with communication and psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
In depth interview guide to understand caregivers experiences in managing daily occupations of people with dementia
Zarit Burden Interview
Clinical Dementia Rating |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/07/2020 |
| Date of Study Completion (India) |
09/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a qualitative study with phenomenological approach, which aims to explore the caregivers experiences in managing daily occupations of people with dementia. The objective of the study is to understand the problems caregivers face and the strategies they use in managing daily occupations of people with dementia. Clinical Dementia Scale will be used to determine the stage of dementia. Zarit Burden Interview will be used to know the caregiver burden. Following which, in-depth semi-structured interview will be conducted for the caregivers, which will be audio recorded. The recorded interview will be translated and transcribed verbatim. The transcribed interview will be coded and using thematic analysis, themes and subgroups will be formed. The semi-structured interview and Zarit Burden Interview will be conducted through telephone or in-person. Clinical Dementia Rating score will be obtained from the medical records, if unavailable the scale will be administered online or in person. |