| CTRI Number |
CTRI/2023/05/052361 [Registered on: 08/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to test a family based educational intervention on the burden of primary caregivers of older persons with dementia |
|
Scientific Title of Study
|
Impact of extending educational interventions to other family members on the burden of primary caregivers of mild to moderate dementia – A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshama Bangera |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8762379439 |
| Fax |
|
| Email |
kshama.bangera2@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 Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
0820-2922188 |
| 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 Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
0820-2922188 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Kshama Bangera |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| 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 |
| Kshama Bangera |
Kasturba Hospital |
Department of Occupational Therapy, 1st Floor, N1 Block, Kasturba Hospital
Udupi
KARNATAKA
Udupi
KARNATAKA |
8762379439
kshama.bangera2@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Caregivers of Persons with Dementia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family Education Program |
The intervention will include four family sessions, each of 45-60 minutes, carried out once a week. The intervention will be completed in a month. It will include information related to dementia, its impact on primary caregivers and family, potential challenges in caregiving and strategies to address the same as a family, especially communication among family members. An information booklet will be provided, and two telephonic support calls will be provided in the second and third month. |
| Comparator Agent |
Primary Caregiver Education |
This will include two sessions of dementia education, each of 45-60 minutes, carried out once a week. An information booklet will be provided. Telephonic support calls will be provided in the second and third month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Phase I: Healthcare professionals must meet the inclusion criteria i.e., having at least a year of experience working with persons with dementia. Primary caregivers and family members of OPwD aged 18 years and above.
Phase II:
•18 years of age or above, caring for an OPwD with mild to moderate dementia (CDR score of 1 to 2)
•having adequate comprehension and communication in English or Kannada and internet access
•able to identify a secondary caregiver aged 18 years or above having adequate comprehension and communication in English or Kannada and having access to the internet.
|
|
| ExclusionCriteria |
| Details |
•primary caregivers of OPwD who are frail, bed-bound and entirely dependent for all daily activities and those living in nursing homes
•paid carers
•primary caregivers having the presence of major psychiatric conditions (e.g., schizophrenia, manic depressive psychosis, substance dependence) self-reported or identified by the researcher.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caregiver Burden of Primary Caregiver (Zarit Burden Interview) |
Baseline
Post-Assessment-I - A week after the intervention
Post-Assessment-II - 3 Month follow-up after Post-Assessment-I |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caregiver Reaction to memory and behaviour problems associated with dementia |
Baseline
Post-Assessment-I - A week after the intervention
Post-Assessment-II - 3 Month follow-up after Post-Assessment-I |
| Knowledge related to dementia |
Baseline
Post-Assessment-I - A week after the intervention
Post-Assessment-II - 3 Month follow-up after Post-Assessment-I |
| Caregivers need for support |
Baseline
Post-Assessment-I - A week after the intervention
Post-Assessment-II - 3 Month follow-up after Post-Assessment-I |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is carried out as a part of a full-term PhD Programme. The study aims to test the feasibility of an education program for families of persons with mild to moderate dementia. Objectives: 1. To develop and validate a family education program for families of older persons with mild to moderate dementia.
2. To test the feasibility of an education program for families of persons with mild to moderate dementia |