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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Raakhi Tripathi
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- 1.The primary variable is percentage of patients stating ‘Yes/No’ for each item of the Drug Awareness Questionnaire.
Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •A) For Pediatric patients
- •Male or female patients with confirmed diagnosis of Nephrotic Syndrome attending Pediatric or Nephrology OPD.
- •Patients aged 2 years to 18 years.
- •Patients who have been on treatment for more than 1 month.
- •B)For Adult patients
- •Male or female patients with confirmed diagnosis of Nephrotic Syndrome attending Nephrology OPD.
- •Patients aged 18 years to 60 years.
Exclusion Criteria
- •A) For Pediatric patients
- •Parents/caregivers not willing to give informed consent
- •Patients (aged 7-18 years) not willing to give assent
- •Patients admitted in IPD and emergency departments B) For Adult patients
- •Patients not willing to give informed consent
- •Patients admitted in IPD and emergency departments.
Outcomes
Primary Outcomes
1.The primary variable is percentage of patients stating ‘Yes/No’ for each item of the Drug Awareness Questionnaire.
Time Frame: As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months
2.Mean awareness score will be calculated
Time Frame: As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months
3. Mean Awareness Score will be correlated with demographic factors (Age, gender,
Time Frame: As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months
occupation, education and socio-economic status as per Kuppuswamy scale)
Time Frame: As this is a cross-sectional survey, outcomes will be assessed at end of study, i.e, 18 months
Secondary Outcomes
- 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.)
- 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
Investigators
Dr Raakhi Tripathi
Seth GS Medical College and KEM Hospital