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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN60490134 |
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Date of registration:
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16/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomised Trial of How Hospital Patients and Health Care Professionals Judge that Being Restricted to Taking Fluids of Different Consistencies Would Affect Their Quality of Life
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Scientific title:
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A Randomised Trial of the Effect of Different Fluid Consistencies on Quality of Life Estimates Using a Time Trade Off Approach By Hospital Patients and Health Care Professionals |
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Date of first enrolment:
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01/08/2015 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN60490134 |
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Study type:
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Interventional |
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Study design:
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Single-site randomised parallel trial (Quality of life)
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Phase:
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Countries of recruitment
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Ireland
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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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Shaun
O'Keeffe |
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Address:
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Unit 4, Merlin Park Hospital
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Galway
Ireland |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Group 1: Consecutive patients admitted to the medical wards of a 600-bed university teaching hospital, who were judged by medical and nursing staff to be clinically stable and fit to be interviewed.
Group 2: A convenience sample of doctors, nurses and allied health professionals working on the medical wards of the hospital or on an associated rehabilitation unit.
Exclusion criteria: 1. Patients with any of the following diagnoses present: dementia or delirium; stroke, Parkinson’s disease or parkinsonism, multiple sclerosis, dysphagia from any other condition, or receiving a texture modified diet for any reason
2. Those with limited command of English or with other major communication problems
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dysphagia
Signs and Symptoms
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Intervention(s)
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Subjects will be allocated, based on odd and even numbers in a list of random numbers, to drink 250 ml of either mildly (nectar-like) or moderately thick (honey-like) water. Time trade utilities will be elicited using a time trade-off approach using a 10 year life expectancy.
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Primary Outcome(s)
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Individual subject utilities will be elicited in face to face interviews. The average (median as non-parametric analysis planned) utility in each of the randomised groups will be compared.
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Secondary Outcome(s)
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1. Average utilities will be compared between patient and professional groups
2. The effect if any of age and gender on subject utilities will be examined
3. The amount of the sample of thickened fluid that each subject drank will be recorded as less than a third, between one and two thirds and more than two thirds
4. The relationship between the volume consumed and the subsequent utility rating of subjects will be analysed
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Source(s) of Monetary Support
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Health Research Board Student Summer Scholarship and Galway University Hospitals
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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