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临床试验/CTRI/2024/05/067975
CTRI/2024/05/067975尚未招募不适用

Awareness and Medication Adherence among Chronic Kidney Disease Patients: A hospital-based cross-sectional study

Achal Kudtarkar1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Awareness of CKD score and medication adherence among CKD patients score

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with CKD
  • Above 18 years of age.

排除标准

  • Patients having cognitive impairments
  • Patients with speech and hearing impairments.

结局指标

主要结局

Awareness of CKD score and medication adherence among CKD patients score

时间窗: 8 weeks

次要结局

  • Correlation between awareness of CKD among patients & medication adherence(8 weeks)

研究者

发起方
Achal Kudtarkar
申办方类型
Other [Self funding]
责任方
Principal Investigator
主要研究者

Achal Kudtarkar

K S Hegde Medical Academy, Mangaluru

研究点 (1)

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