| CTRI Number |
CTRI/2022/05/042546 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes
Behavioral
Other (Specify) [Educational ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of empowerment program for caregivers of people with dementia |
|
Scientific Title of Study
|
Efficacy of Interprofessional Caring Empowerment Programme (ICEP) on caregiver burden, quality of life, abuse and neglect among the caregivers of people living with dementia - A Randomized 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 |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room Number - 108
First Floor
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
8310769938 |
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room Number - 108
First Floor
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
8310769938 |
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room Number - 108
First Floor
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
8310769938 |
| Email |
elsa.sana@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing Manipal Academy of Higher Education |
| Address |
Manipal College of Nursing
Kasturba Medical College
Manipal Academy of Higher Education
Madhavnagar
Manipal, Udupi District Karnataka |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
MANIPAL COLLEGE OF NURSING |
ROOM NUMBER 108
FIRST FLOOR
MANIPAL COLLEGE OF NURSING
MANIPAL
Udupi
KARNATAKA |
8310769938
08202922443
elsa.sana@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human volunteers (caregivers of people living with dementia) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interprofessional Caring Empowerment Programme |
8 hour intervention programme |
| Comparator Agent |
Routine care |
No intervention, only routine care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers willing to participate
able to understand English or Kannada (local) language
residing in Udupi district |
|
| ExclusionCriteria |
| Details |
Caregivers not willing to participate
Outside Udupi district
caregivers below 18 years and above 70 years
caregivers who are not giving continuous care |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caregiver burden, Quality of life, Abuse, Neglect |
Third month and sixth month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge of caregivers on dementia and coping strategies |
Third and sixth month follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/05/2022 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Will be published after data collection |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a study where Interprofessional Caring Empowerment Programme will be delivered to the caregivers. All the caregivers will be randomized into experimental and control group. The experimental group receives an interprofessional Caring Empowerment Programme and Control group receives routine care. Effectiveness of the programme will be evaluated at the end. |