Main
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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:
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ISRCTN |
Last refreshed on:
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7 December 2020 |
Main ID: |
ISRCTN45318400 |
Date of registration:
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05/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Validation of an instrument for measuring satisfaction of patients undergoing hemodialysis
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Scientific title:
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Validation of an Instrument for Measuring Satisfaction of Patients Undergoing Hemodialysis: ESUR-HD |
Date of first enrolment:
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01/06/2013 |
Target sample size:
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370 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN45318400 |
Study type:
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Observational |
Study design:
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Observational cross-sectional study (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Mauricio
Sanabria |
Address:
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Renal Therapy Services (RTS) Colombia
Transversal 23 #97-73 Piso 6
110221
Bogota
Colombia |
Telephone:
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+57 315 3663465 |
Email:
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mauricio_sanabria@baxter.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Haemodialysis Urological and Genital Diseases Haemodialysis
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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No secondary outcome measures.
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Secondary ID(s)
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BHSR-D-16-00174
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Source(s) of Monetary Support
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Renal Therapy Services (RTS) Colombia
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Ethics review
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Status:
Approval date:
Contact:
Renal Therapy Services Colombia Ethics Committee,11/06/2013, ref: minutes 004
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/12/2013 |
URL:
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