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CTRI Number  CTRI/2024/05/067975 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Awareness and adherence to medication among patients of Chronic Kidney Disease 
Scientific Title of Study   Awareness and Medication Adherence among Chronic Kidney Disease Patients: A hospital-based cross-sectional 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  Achal Kudtarkar 
Designation  MPH Student 
Affiliation  K S Hegde Medical Academy, Mangaluru 
Address  Department of Public Health, K. S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9637114628  
Fax    
Email  achalckudtarkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr. Prajwal Jupiter Lobo 
Designation  Assistant Professor 
Affiliation  K S Hegde Medical Academy, Mangaluru 
Address  Department of Public Health, K. S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8828224857   
Fax    
Email  prajwal.lobo@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Achal Kudtarkar 
Designation  MPH Student 
Affiliation  K S Hegde Medical Academy, Mangaluru 
Address  Department of Public Health, K. S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9637114628  
Fax    
Email  achalckudtarkar@gmail.com  
 
Source of Monetary or Material Support  
Self funded study, Infrastructural Support: Justice K. S. Hegde Charitable Hospital, Deralakatte Mangaluru Karnataka India, 575018 
 
Primary Sponsor  
Name  Achal Kudtarkar 
Address  K S Hegde Medical Academy, Deralakatte, Mangaluru 
Type of Sponsor  Other [Self funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Achal Kudtarkar  Justice K. S. Hegde Charitable Hospital  Department of Nephrology, Outpatient Departments, Wards and Dialysis Unit
Dakshina Kannada
KARNATAKA 
9637114628

achalckudtarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, K S Hegde Medical Academy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with CKD
2. Above 18 years of age
 
 
ExclusionCriteria 
Details  1. Patients having cognitive impairments
2. Patients with speech and hearing impairments
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Awareness of CKD score and medication adherence among CKD patients score  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between awareness of CKD among patients & medication adherence  8 weeks 
 
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)   17/06/2024 
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="0"
Months="2"
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  

AWARENESS AND MEDICATION ADHERENCE AMONG CHRONIC KIDNEY DISEASE PATIENTS: A HOSPITAL-BASED CROSS-SECTIONAL STUDY

RESEARCH QUESTIONS

Among Chronic Kidney Disease (CKD) patients visiting Justice K. S. Hegde Charitable Hospital, Deralakatte, Mangaluru from January 2024 to June 2024,

1)     what is the awareness score of their currently perceived CKD condition?

2)     what is the medication adherence score among them?

3)     what are the factors associated with awareness of CKD and medication adherence?

4)     is there any correlation between awareness of CKD and medication adherence?

 

METHODOLOGY 

Study design 

A hospital-based cross-sectional study.

Study setting 

This study will be conducted in the Justice K. S. Hegde Charitable Hospital, which is located in Deralakatte, Mangaluru, Karnataka.

Study population 

Patients above 18 years of age, diagnosed with CKD attending outpatient department (OPD) for routine checkups, inpatients (IP), and patients on dialysis will be included in the study.

Inclusion criteria

·        Patients diagnosed with CKD

·        Above 18 years of age

Exclusion criteria 

·        Patients having cognitive impairments 

·        Patients with speech and hearing impairments

Study duration 

The study will be conducted from October 2023 to July 2024. Data will be collected between June 2024 and July 2024.

Sample size calculation 

This will be a time-bound study where data will be collected from June to July 2024. For the study, the anticipated sample size will be drawn from the pool of CKD patients visiting the outpatient department (OPD) for check-ups, inpatients (IP), and those undergoing hemodialysis within a specified period. Considering the number of monthly CKD patients hospital receives as seen from records, my anticipation for the study’s sample size revolves around the prospect of including around 200 patients throughout the study period.

Sampling method

A convenience sampling method will be used to include participants in the study.

Study instrument and process of administration  

After gaining the participants’ written consent, a validated semi-structured questionnaire will be used to conduct interviews with the participants. The questionnaire includes:

Section 1: (a) Sociodemographic factors, (b) Clinical profile, (c) Lifestyle factors

Section 2: Questions to assess awareness about their disease condition among CKD patients. To determine the awareness, a pre-validated 18-item ‘Chronic Kidney Disease Patient Awareness Questionnaire’ will be used.

Section 3: It includes the ‘Adherence to Refills and Medications Scale’ (ARMS) (33). This scale comprises 12 items rated on a 4-point Likert scale and is utilized to assess self-reported adherence to medication intake and refills.

Validation of the tool    

Five subject experts did the content validity of the questionnaire except for ‘chronic kidney disease patient questionnaire’ and ‘ARMS’, which are already validated, and one language expert did the content validation of the questionnaire in the local language except for ‘ARMS’ which is already available in the local language. Based on the guidelines and suggestions from the experts, the final version of the questionnaire will be prepared.

Data collection and quality control

• Data will be collected by the student researcher

• The guide will monitor data collection at regular intervals

• Each question’s meaning will be explained to the participants by the researcher

Study variables

Independent variables

Age, gender, residence, education, occupation, marital status, family income, insurance status, out-of-pocket expenditure, patient type, duration of CKD, CKD stage, comorbidities, family history, tobacco usage, alcohol consumption, exercise, NSAIDs use, complimentary and alternate medication use.

Outcome variables

Awareness of CKD and medication adherence among CKD patients.

Plan for data analysis

The data will be collected in paper-based forms and entered using Epi Data Manager. Further data will be exported to SPSS version 20 for analysis. Categorical variables will be tabulated as frequencies and percentages. Continuous variables will be summarised as mean (SD) or median (IQR) based on the normality of the data; the number of family members will be summarised as median (IQR).

An independent t-test or Mann-Whitney U test will be employed for two group means and a one-way ANOVA or Kruskal Wallis test will be used for more than two groups to compare the domains to demographic data depending on the normality of data. To find the correlation between awareness and medication adherence Karl Pearson’s Correlation or Spearman’s Rank Correlation will be employed depending on the normality of the data. P value <0.05 will be considered statistically significant.

 

Name and contact details of investigator - Kudtarkar Achal Chandrakant, Master of Public Health (MPH) scholar, Department of Public Health, K. S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru.

Contact Details: 9637114628, Email ID; achalckudtarkar@gmail.com

Name and contact details of Guide - Mr. Prajwal Jupiter Lobo, Guide and Assistant Professor, Department of Public Health, K. S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru.

Contact Details: 8828224857 (Monday to Friday – 9.00 am to 4.00 pm, Saturday – 9.00 am to 1.00 pm. Except public holidays), Email ID; prajwal.lobo@nitte.edu.in

Name and contact details of co-guide - Dr. Pradeep Shenoy M., Assistant Professor, Department of Nephrology, K. S. Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru.

Contact details: 9844546066 (Monday to Saturday – 9.00 am to 4.00 pm, Except public holidays), Email ID; mpradeepshenoy@gmail.com


 
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