| CTRI Number |
CTRI/2025/02/081084 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
To find the factors to be included in policy of the care giver who is taking care of chronically ill patients |
|
Scientific Title of Study
|
Identification of components required to construct a policy essential for reducing caregivers burden An Interview Based Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namrata Bhadbhade |
| Designation |
Asst. Professor |
| Affiliation |
D.E.S Brijlal Jindal College of Physiotherapy |
| Address |
D.E.S Brijlal Jindal College of Physiotherapy,Musculoskeletal sciences department, division 1, room number 2, Fergusson college campus, sivaji nagar, Pune.
Pune
MAHARASHTRA
411004
India |
| Phone |
07709404336 |
| Fax |
- |
| Email |
namratasidhaye.physio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Dhavale |
| Designation |
Intern |
| Affiliation |
D.E.S Brijlal Jindal College of Physiotherapy |
| Address |
D.E.S Brijlal Jindal College of Physiotherapy,Musculoskeletal sciences department, division 1, room number 2, Fergusson college campus, sivaji nagar, Pune.
Pune
MAHARASHTRA
411004
India |
| Phone |
9930841725 |
| Fax |
- |
| Email |
rahuld2626@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Bhadbhade |
| Designation |
Asst. Professor |
| Affiliation |
D.E.S Brijlal Jindal College of Physiotherapy |
| Address |
D.E.S Brijlal Jindal College of Physiotherapy,Musculoskeletal sciences department, division 1, room number 2, Fergusson college campus, sivaji nagar, Pune.
Pune
MAHARASHTRA
411004
India |
| Phone |
07709404336 |
| Fax |
- |
| Email |
namratasidhaye.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.E.societys Brijlal Jindal College of physiotherapy, Fergusson college campus, Shivajinagar, Pune- 411004 |
| Rahul Dhavale |
|
|
Primary Sponsor
|
| Name |
Rahul Dhavale |
| Address |
D.E.Societys Brijlal Jindal College of Physiotherapy Fergusson college campus Shivajinagar Pune 411004 |
| 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 Namrata Bhadbhade |
D.E.S Brijlal Jindal College of Physiotherapy |
D.E.S Brijlal Jindal College of Physiotherapy,Musculoskeletal sciences department, division 1, room number 2, Fergusson college campus, shivaji nagar, Pune 411004
Pune
MAHARASHTRA |
07709404336
namratasidhaye.physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DES BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Primary caregivers of chronically ill dependent patient with moderate to maximal disability for more than 6 months. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| qualitative semi structured interview |
at the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/03/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Primary care givers play a key role in the management of chronically ill patient. There is lot of physical, psychological, financial and social burden on care giver. There are lot of policies for patient , none is for care giver. This study aims to find out components that the caregiver needs help while providing care to the patient by government or NGOs. Sample size is 20. For data collection semi structured interview will be conducted and same will be recorded. After collection of all samples recordings will be heard again and data will be categorized in to different themes. According to themes the needs of the primary care giver will be known. |