| CTRI Number |
CTRI/2025/07/090396 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Looking after Medicines at Home for Kidney Disease Patients in Udupi District |
|
Scientific Title of Study
|
Feasibility of Implementing Home Medication Review among End-Stage Renal Disease Patients in the Community-Setting in Udupi District: A Pharmacoeconomic 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 |
Sushanth K |
| Designation |
PhD Research Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal.
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal, 576104.
Udupi
KARNATAKA
576104
India |
| Phone |
8277258973 |
| Fax |
|
| Email |
sushanth.mcopsmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Thunga |
| Designation |
Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal.
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal, 576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9880151127 |
| Fax |
|
| Email |
girish.thunga@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Thunga |
| Designation |
Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal.
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal, 576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9880151127 |
| Fax |
|
| Email |
girish.thunga@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India. 576104. |
|
|
Primary Sponsor
|
| Name |
Centre for Toxicovigilance and Drug Safety |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal. 576104. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish Thunga |
Adarsha Hospital |
Room number 12, Ground Floor, Department of Nephrology, Division of Dialysis, Adarsha Hospital, Near KSRTC Bus stand, Udupi, Karnataka 576101
Udupi
KARNATAKA |
9880151127
girish.thunga@manipal.edu |
| Dr Girish Thunga |
Kasturba Hospital |
Room Number 8, 4th Floor, Deapartment of Nephrology, Division of Dialysis, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka. 576104.
Udupi
KARNATAKA |
9880151127
girish.thunga@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Katurba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
| Katurba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Home Medication Review |
Home Medication Review is a consumer-focused, organized and collaborative healthcare service provided in the community-setting that offers a potential approach to optimize medication usage, support adherence, and improve patient outcomes. The HMR will be provided for the duration of 1 year to the patients who are undergoing dialysis. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ESRD patients undergoing dialysis treatment for 2-3 sessions per week.
ESRD patients who are 18 years and above.
ESRD patients who are able to talk and give consent
|
|
| ExclusionCriteria |
| Details |
The patients who are not undergoing dialysis treatment.
Pediatric ESRD patients
ESRD patients who are bedridden.
ESRD patients who are paralyzed.
ESRD patients who are not willing to give consent due to other reasons.
The patients who are having cultural limitations.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the assessment of reduction in the cost between pre and post intervention. |
The patients will be followed-up in 4 time-points. Firstly, before providing the intervention and 3,6 and 12 months after providing the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is to assess the Quality of Life of the patients between pre and post intervention. |
The patients will be followed-up in 4 time-points. Firstly, before providing the intervention and 3,6 and 12 months after providing the intervention. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is conducted in 4 phases. Phase 1 focuses on systematically assessing the impact of HMR especially in dialysis patients through the scoping review. Phase 2 involves conducting the Qualitative Interviews to understand the perspectives of healthcare professionals and patients with respect to the cost associated with the dialysis, economic burden and other healthcare facilities available. In the next step, based on the findings from the literature review and interviews, an intervention will be developed and piloted in a small cohort of 12 patients. Following the pilot, outcomes will be evaluated to estimate the required sample size for the main study. The final phase will be implemented across two centers, starting with baseline assessments, followed by the intervention. Outcomes will be assessed at three time points—3, 6, and 12 months—focusing on reducing overall costs and economic burden, as well as improving quality of life. |