| CTRI Number |
CTRI/2020/02/023362 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
10/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nurse led Intervention on Caregivers of Dementia |
|
Scientific Title of Study
|
“Effectiveness of Nurse-led Intervention on caregiver burden and
Quality of Life among the primary caregivers of patients with dementia – A Randomized
Controlled Trial†|
| Trial Acronym |
Nurse Led Intervention for Dementia Caregivers |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Registered elsewhere |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CLARITA SHYNAL MARTIS |
| Designation |
PhD SCHOLAR |
| Affiliation |
Manipal College of Nursing |
| Address |
Room No 404
Dept of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7019752085 |
| Fax |
- |
| Email |
cleritashynalmartis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
CLARITA SHYNAL MARTIS |
| Designation |
PhD SCHOLAR |
| Affiliation |
Manipal College of Nursing |
| Address |
Room No 404
Dept of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7019752085 |
| Fax |
- |
| Email |
cleritashynalmartis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ELSA SANATOMBI DEVI |
| Designation |
PROFESSOR |
| Affiliation |
Manipal College of Nursing |
| Address |
Room No 401
Dept of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
- |
| Email |
elsa.sana@manipal.edu |
|
|
Source of Monetary or Material Support
|
| No monetary source for this study |
|
|
Primary Sponsor
|
| Name |
Not Apllicable for this study |
| Address |
Not Applicable for this study |
| Type of Sponsor |
Other [] |
|
|
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 Elsa Sanatombi Devi |
Kasturba Hospital Manipal |
Room No 33
Department of Psychiatry
Udupi
KARNATAKA |
8310769938
-
elsa.sana@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 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Nurse led intervention on Caregiver burden and quality of life |
This intervention includes
Video teaching on Dementia and its care
Booklet on self care during dementia for caregivers
The duration of Video teaching is 15 minutes
Teaching yoga techniques such as asanas and pranayama to caregivers which is for about 30-45 minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of the Dementia Patients who are
above the age of 18 years and below the age of 75 years
who are willing to participate in the study
Paid caregivers who worked with the people with dementia for more than 3 months
|
|
| ExclusionCriteria |
| Details |
Caregivers below the age of 18 years
Physically and mentally challenged caregivers
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Nurse led Intervention |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increase in Knowledge on dementia
Decrease in Caregiver burden
Increase in Coping strategies
Increase in quality of life |
Six months |
|
|
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)
|
20/02/2020 |
| 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="3"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Will be published after the data analysis |
|
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 done as a part of full term PhD Programe. This study aims to identify the effectiveness of Nurse led Intervention for primary caregivers of dementia patient. Randomized Controlled trial research design is used for this study. This study includes the caregivers of the dementia patients who are above the age of 18 years and those who are able to understand English, Kannada, Hindi and Tulu languages. |