| CTRI Number |
CTRI/2020/07/026919 [Registered on: 30/07/2020] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Self Support Group (SSG) for Chronic Renal Failure (CRF) Patients and Caregivers. |
|
Scientific Title of Study
|
Efficacy of Empowerment of newly developed Self Support Group (SSG) of Chronic Renal Failure (CRF) Patients and Caregivers on their Quality of Life. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjana Sharma |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed to be University) Sawangi (Meghe) Wardha |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi (Meghe) Wardha
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442007
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranjana Sharma |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed to be University) Sawangi (Meghe) Wardha |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi (Meghe) Wardha
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442007
India |
| Phone |
09960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjana Sharma |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed to be University) Sawangi (Meghe) Wardha |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi (Meghe) Wardha
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442007
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical sciences (Deemed to be University), Acharya Vinoba Bhave Rural Hospital Sawangi (Meghe) wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical sciences Deemed to be University Sawangi Meghe wardha |
| Address |
Sawangi (Meghe) Wardha |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Research and Development cell Datta Meghe Institute of Medical sciences Deemed to be University |
Sawangi (Meghe) Wardha
pin-442007, Maharashtra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seema singh |
Acharya Vonoba Bhave Rural Hospital, Sawangi (Meghe) wardha |
DMIMS Campus, Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA |
9960303761
seemasingh.457@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute Of medical Science (Deemed to be University) Sawangi (Meghe) Wardha |
Approved |
| Institutional Ethics Committee, Datta Meghe Institute Of medical Science (Deemed to be University) Sawangi (Meghe) Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Self Support Group |
Formation Of Support Group For CRF patients and their caregivers in Hospital Setting.
Time duration 1 year for intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Available at the time of data collection
2. Chronic renal failure patients.
3. Both male and female patients.
4. Both male and female caregivers.
5. Ambulatory patients only.
|
|
| ExclusionCriteria |
| Details |
1. Chronic Renal Failure patients with tuberculosis, HIV/AIDS, Chronic Heart Diseases, Chronic Liver Diseases, Temporary dialysis, Malignancies.
2. Impaired cognition, unable to follow the instructions of investigator at the time of data collection.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Formation of Support Group For Chronic Renal Failure Patients and their caregivers. |
3 months, 6 months and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the quality of life of both chronic renal failure patients and caregivers. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| Date of Study Completion (India) |
03/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2021 |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
A. Published In IJRAR
(www.ijrar.org ) ISSN UGC Approved & 5.75 Impact Factor, Volume 6 Issue 1 February-2019.
B. Journal of Pharmaceutical Research International
33(35B): 162-168, 2021; Article no. JPRI.70814
ISSN: 2456-9119
2. Protocol: 33(38B): 180-186, 2021;Article no.JPRI.71197ISSN: 2456-9119.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Empowerment of self-support group and orientation about disease condition was found significantly effective to improve quality of life and knowledge of CRF patients and their caregivers.
|