The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.
Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Following the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Health and feeding related quality of life
At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.
Time frame: Baseline to end of intervention (Day 35)
Ease of administration
At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.
Time frame: Baseline to end of intervention (Day 35)
Liking of feeding method
At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.
Time frame: Baseline to end of intervention (Day 35)
Gastrointestinal tolerance
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.
Time frame: Baseline to end of intervention (Day 35)
Compliance
Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.
Time frame: Baseline to end of intervention (Day 35)
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University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
County Durham and Darlington NHS Foundation Trust
Darlington, United Kingdom
NHS Tayside
Dundee, United Kingdom
Royal Surrey NHS Foundation Trust
Guildford, United Kingdom
Betsi Cadwaladr University Health Board
Holywell, United Kingdom
Calderdale & Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom
Leicestershire Partnership NHS Trust
Leicester, United Kingdom
North East London NHS Foundation Trust
London, United Kingdom
...and 5 more locations
Nutrient intake
At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.
Time frame: Baseline to end of intervention (Day 35)
Body weight (kg)
At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.
Time frame: Baseline to end of intervention (Day 35)
Adverse Events
All adverse events will be recorded throughout the study.
Time frame: Baseline to end of intervention (Day 35)