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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 7 December 2020
Main ID:  ISRCTN45318400
Date of registration: 05/04/2017
Prospective Registration: No
Primary sponsor: Renal Therapy Services (RTS) Colombia
Public title: Validation of an instrument for measuring satisfaction of patients undergoing hemodialysis
Scientific title: Validation of an Instrument for Measuring Satisfaction of Patients Undergoing Hemodialysis: ESUR-HD
Date of first enrolment: 01/06/2013
Target sample size: 370
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN45318400
Study type:  Observational
Study design:  Observational cross-sectional study (Other)  
Phase:  Not Applicable
Countries of recruitment
Colombia
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Mauricio    Sanabria
Address:  Renal Therapy Services (RTS) Colombia Transversal 23 #97-73 Piso 6 110221 Bogota Colombia
Telephone: +57 315 3663465
Email: mauricio_sanabria@baxter.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Adult patient undergoing hemodialysis
2. Colombian nationals
3. Speak Spanish
4. Aged 18 and older

Exclusion criteria:
1. Cognitive impairment, documented in the institutional clinical history, that prevents an adequate understanding of the questions contained in the instrument.
2. Sensory alterations, documented in the institutional clinical history, that prevent the patient from hearing the questions asked or responding to them in a telephone survey.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Haemodialysis
Urological and Genital Diseases
Haemodialysis
Intervention(s)

After conducting four focus groups that include three nurses, a nephrologist and two administrative employees in four different regions of Colombia that asked about patient satisfaction, a scale for evaluating patients' satisfaction with the renal services ESUR-HD was created. The focus group defined certain dimensions with patient satisfaction that include overall satisfaction with the services, personnel at the unit, medications and supplies, facilities and processes, and phone contact. The ESUR-HD scale uses 44 items that are rated from one to five using a Likert scale. The final score is obtained by non-weighted sum of the score given to each item (higher scores reflect increased patient satisfaction). The survey takes 15 minutes to complete.

Participants who underwent hemodialysis at the clinics in 2013 are contacted by telephone to participate in the ESUR-HD scale. In order to measure convergent validity, the SDIALOR scale is simultaneously applied in a smaller subgroup of patients. The SDIALOR scale consists of seven domains (organisation of medical care, relationship between nephrologists and general practitioner, locational characteristics, accessibility, care provided by the health personnel, information provided by the doctor, problem solving, overall satisfaction). In order to test the reliability of the study a smaller sample of participants were re-surveyed two days after their initial assessment to consider the scale length. In order to establish the sensitivity to change, another smaller sample of participants are re-evaluated one month after using a new renal clinical within a hospital that includes remodelled spaces, waiting rooms, newer equipment, with more familiar, expert and dedicated healthcare staff.
Primary Outcome(s)

1. Convergent validity is assessed by comparing the correlation coefficients based on results of ESUR-HD and SDIALOR at baseline.
2. Test-retest reliability is measured using repeat surveys of ESUR-HD at baseline and day 2.
3. Sensitivity to change is assessed by comparing the ESUR- HD scale scores at baseline and one month after improved care conditions
Secondary Outcome(s)
No secondary outcome measures.
Secondary ID(s)
BHSR-D-16-00174
Source(s) of Monetary Support
Renal Therapy Services (RTS) Colombia
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Renal Therapy Services Colombia Ethics Committee,11/06/2013, ref: minutes 004
Results
Results available: Yes
Date Posted:
Date Completed: 01/12/2013
URL:
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