| CTRI Number |
CTRI/2025/09/094043 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate Drug Awareness, Medication Adherence and Drugs Prescribed in Patients of Nephrotic Syndrome |
|
Scientific Title of Study
|
Evaluation of Drug Awareness, Medication Adherence and Prescription Patterns in Patients of Nephrotic Syndrome Attending a Tertiary Care Hospital: A Cross-sectional, Questionnaire-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 |
Dr Raakhi Tripathi |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, College building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra
India
Mumbai MAHARASHTRA 400012 India |
| Phone |
9821724700 |
| Fax |
|
| Email |
lookon@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Avanti Kajrolkar |
| Designation |
Junior Resident |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, College building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra
India
Mumbai MAHARASHTRA 400012 India |
| Phone |
8454009253 |
| Fax |
|
| Email |
avkajrolkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Raakhi Tripathi |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, College building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra
India
Mumbai MAHARASHTRA 400012 India |
| Phone |
9821724700 |
| Fax |
|
| Email |
lookon@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai 400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Raakhi Tripathi |
| Address |
Department of Pharmacology & Therapeutics, College Building, First Floor, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, India
|
| 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 Raakhi Tripathi |
Seth GS Medical College and KEM Hospital |
Nephrology OPD, Department of Nephrology, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra
and
Pediatric OPD, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra
Mumbai MAHARASHTRA |
9821724700
lookon@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)-III Relating to Biomedical and Health Research (BHR), Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N04||Nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) For Pediatric patients
1. Male or female patients with confirmed diagnosis of Nephrotic Syndrome attending Pediatric or Nephrology OPD.
2. Patients aged 2 years to 18 years.
3. Patients who have been on treatment for more than 1 month.
B)For Adult patients
1. Male or female patients with confirmed diagnosis of Nephrotic Syndrome attending Nephrology OPD.
2. Patients aged 18 years to 60 years.
3. Patients who have been on treatment for more than 1 month.
|
|
| ExclusionCriteria |
| Details |
A) For Pediatric patients
1. Parents/caregivers not willing to give informed consent
2. Patients (aged 7-18 years) not willing to give assent
3. Patients admitted in IPD and emergency departments
B) For Adult patients
1. Patients not willing to give informed consent
2. Patients admitted in IPD and emergency departments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The primary variable is percentage of patients stating ‘Yes/No’ for each item of the Drug Awareness Questionnaire.
2.Mean awareness score will be calculated
3. Mean Awareness Score will be correlated with demographic factors (Age, gender,
occupation, education and socio-economic status as per Kuppuswamy scale)
|
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate perceived Medication Adherence which will be assessed by the percentage of patients stating ‘Yes/No’ for each item of the Medication Adherence Questionnaire.
For evaluating actual Medication Adherence, the percentage of Medication Adherence will be calculated using pill count method formula.
|
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months. |
| To study the pattern of drugs used in the treatment of Nephrotic Syndrome |
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months |
To evaluate the prescribed drug regimen as per the package insert of the prescribed drugs
|
As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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)
|
18/09/2025 |
| 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="1" Months="6" 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 - YES
- What data in particular will be shared?
Response (Others) - Data will be shared without revealing identity of participant for publication and presentations.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response (Others) - Questionnaire, Case Record Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [avkajrolkar@gmail.com].
- For how long will this data be available start date provided 26-08-2025 and end date provided 31-12-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Nephrotic Syndrome is the most common glomerular disease in children and an important cause of chronic kidney disease (CKD) in adults. It is defined by the presence of proteinuria, hypoalbuminemia, and edema, often accompanied by hyperlipidemia and lipiduria. Management involves corticosteroids as the mainstay in children, with treatment response determining prognosis. Adults are treated based on underlying histology, with corticosteroids and second-line immunosuppressants forming the cornerstone of therapy. Nephrotic Syndrome is associated with multiple complications including edema, hypertension, infections, hyperlipidemia, and thromboembolic events, which are managed by supportive medications such as diuretics, antihypertensives, hypolipidemic drugs, antimicrobials and anticoagulants. Poor medication adherence in patients of nephrotic syndrome has been linked to increased frequency of relapses, steroid resistance, complications, and increased healthcare costs. Hence, medication adherence is a vital focus for overall disease outcomes in pediatric and adult nephrotic syndrome patients. There have been very few studies evaluating medication adherence in Nephrotic Syndrome in India. Hence, this study has been undertaken to assess medication adherence. Patient and caregiver awareness plays an important role in effective management of the condition. Adequate knowledge and awareness can help overcome the problems of poor adherence, misuse of medications, late identification of relapses and preventable complications. There has been no study done in India focused on detailed evaluation of Drug Awareness in Nephrotic Syndrome- including side effects and self-medication. There has also been no study on evaluation on Drug Awareness in adult as well as pediatric patients of nephrotic syndrome. Hence, the present study aims to evaluate Drug Awareness in patients of Nephrotic Syndrome The treatment involves several drug classes with multiple drugs under each, resulting in variability in prescription patterns. There are only a few studies evaluating prescription patterns in Nephrotic Syndrome from Western India and there has been no study on evaluation of prescription patterns of nephrotic syndrome in Maharashtra. Hence, this study aims to assess prescription patterns in patients of nephrotic syndrome to identify real world treatment trends, adherence to standard treatment guidelines and variations across the age groups and healthcare providers Patients of Nephrotic Syndrome have varying degrees of renal impairment for which dose adjustments are necessary. Improper doses of drugs can increase the risk of treatment failure and can lead to side-effects. Hence, assessing appropriateness of renal dose adjustments in patients of Nephrotic Syndrome is also necessary. Till date, there has been no single study comprehensively evaluating Drug Awareness, perceived Medication Adherence and Prescription Patterns in Nephrotic Syndrome. Hence, the present study has been planned. Primary Objective: To evaluate the Drug Awareness in Adult patients & Parents/Caregivers of children suffering from Nephrotic Syndrome using a validated Drug Awareness Questionnaire. Secondary Objective: To evaluate perceived medication adherence in patients of Nephrotic Syndrome using a validated Medication Adherence Questionnaire. To evaluate the prescription pattern of drugs used in treatment of patients of Nephrotic Syndrome. To evaluate the prescribed drug regimen as per the package insert of the prescribed drugs.
The sample size will be 50 pediatric patients and 200 adult patients which is a total of 250 patients. Sample size has been calculated by convenience sampling method. Primary and Secondary variables will be measured. Statistical analysis will be done.
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