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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus Pouch Feed | Experimental | A 250 ml feeding pouch containing 400 kcal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus Pouch Feed | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of intervention (Day 35) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of intervention (Day 35) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Stratton, PhD | Nutricia UK Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Sussex NHS Foundation Trust | Brighton | United Kingdom | ||||
| Cambridge University Hospitals NHS Foundation Trust |
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This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
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|
| 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. | 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©. | 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. | Baseline to end of intervention (Day 35) |
| 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. | 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. | Baseline to end of intervention (Day 35) |
| Adverse Events | All adverse events will be recorded throughout the study. | Baseline to end of intervention (Day 35) |
| Cambridge |
| United Kingdom |
| 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 |
| Northumbria Healthcare NHS Foundation Trust | Newcastle upon Tyne | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | United Kingdom |
| Southern Health NHS Foundation Trust | Southampton | United Kingdom |
| South Warwickshire NHS Foundation Trust | Warwick | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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