Plain English Summary
Background and study aims
Swallowing problems (dysphagia) are common especially in older people, and are associated with numerous medical conditions including stroke, dementia and head and neck cancers. A common complication of dysphagia is inhaling fluid into the lungs, causing an infection. Thin consistency liquids, such as water, are the most likely consistency to be inhaled so the thickening of fluids with commercial thickeners is commonly advised to minimise this risk. However patients often dislike thickened fluids because of the unpleasant taste, the greater effort required to drink these fluids and poor thirst-quenching ability. This means that patients prescribed thickened fluids consume less fluid than patients who are able to drink thin fluids.
The aim of the study is to find out whether people who drink X would be prepared to live less in exchange for a better quality of life compared to people who drink Y.
Who can participate?
A mix of medically stable adults admitted to hospital and fit for interview and of healthcare professionals.
What does the study involve?
Participants will be randomly allocated to one of two groups: one group will be required to drink 250ml of a mildly thickened solution, and the other will be asked to drink 250ml of a moderately thickened solution. All participants will then be asked to imagine themselves having ten years to live, only being able to consume fluid in the form their group was given and whether they would be prepared to give up any years from the rest of their lives if it meant being able to live in full health.
What are the possible benefits and risks of participating?
There are no notable benefits or risks of participating.
Where is the study run from?
Galway University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
July 2015 – August 2015
Who is funding the study?
Health Research Board Student Summer Scholarship and Galway University Hospitals (Ireland)
Who is the main contact?
Professor Shaun O’Keefe
Trial website
Contact information
Type
Scientific
Primary contact
Prof Shaun O'Keeffe
ORCID ID
http://orcid.org/0000-0002-7682-5004
Contact details
Unit 4
Merlin Park Hospital
Galway
-
Ireland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
The primary hypothesis was that heath care utilities would be lower for those randomised to receive a sample of a more viscous fluid (moderately rather than mildly thick consistency).
Ethics approval
Galway University Hospital Clinical Research Ethics Committee, 20/05/2015, ref: CA 245
Study design
Single-site randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Dysphagia
Intervention
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.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/07/2015
Overall trial end date
30/08/2015
Reason abandoned
Eligibility
Participant 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.
Participant type
Mixed
Age group
All
Gender
Both
Target number of participants
75 patients; 75 healthcare professionals
Participant 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
Recruitment start date
01/08/2015
Recruitment end date
01/08/2015
Locations
Countries of recruitment
Ireland
Trial participating centre
Galway University Hospitals
Newcastle Rd
Galway
-
Ireland
Funders
Funder type
Hospital/treatment centre
Funder name
Health Research Board Student Summer Scholarship and Galway University Hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to submit for presentation in relevant conferences (such as those relating to geriatric medicine, nutrition or speech and language therapy) and for publication in a peer-reviewed journal.
Intention to publish date
01/10/2015
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary