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NCT01509716 Clinical Trial

Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis Chronic Kidney Disease (CKD) Patients

Chronic Kidney Disease Stage 5 Clinical Trial

Official title:
Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis CKD Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01509716
Other study ID # DSRB Domain E/2011/02008
Secondary ID
Status Recruiting
Phase N/A
First received January 6, 2012
Last updated April 14, 2015

Study information
Verified date April 2015
Source National University, Singapore
Contact Priscilla P How, Pharm.D.
Phone (65) 6516 4906
Email priscillahow@nus.edu.sg
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Observational

Clinical Trial Summary

Aims: The investigators' primary objective is to assess both perceived and actual disease knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators hypothesize that actual disease knowledge is poorer than perceived. As the secondary objectives, the investigators will also assess the HRQoL and examine the association between level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize that HRQoL of pre-dialysis CKD patients is poorer than that of the general population while pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with poorer knowledge.

Methodology: A survey was developed to assess both perceived and actual knowledge on five aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL, the following questionnaires will be used - Kidney Disease Quality of Life-Short Form (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main languages - English, Chinese and Malay. A standardized data collection form was developed to retrospectively collect demographic and clinical information from the patients' electronic medical records and patient charts. Descriptive statistics will be used to report all results.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients at least 21 years of age,

- able to read English, Chinese or Malay,

- have stage 3 to 5 CKD as identified from their medical records, but are not receiving dialysis.

Exclusion Criteria:

- patients who do not consent,

- have already been started on dialysis,

- are cognitively impaired as assessed by the recruiter or unable to fill up questionnaires on their own.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)
Lead Sponsor Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

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