Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451679
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-03
Brief Title:
Postoperative Dietary Intake of Hip Fracture Patients
Sponsor:
Teesside University
Organization:
Teesside University
Study Overview
Official Title:
An Observation Study of Postoperative Dietary Intake of Older Adult Hip Fracture Patients a Weighed Food Diary
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to observe the postoperative dietary intake in older adult hip fracture patients from their day of surgery day zero until day three inclusive The aims of this study are
Primary aim
To observe if the postoperative dietary energy intake kJkcal of older adult hip fracture patients meets Resting Energy Expenditure REE needs
Secondary aims
To explore if there is a correlation between postoperative dietary intake and length of hospital stay
To explore the relationship between comorbidity where reported and postoperative dietary intake according to dietary intake
To explore if in the development of postoperative complications infection pressure ulcer and VTE there is a correlation with postoperative dietary intake
Primary aim
To observe if the postoperative dietary energy intake kJkcal of older adult hip fracture patients meets Resting Energy Expenditure REE needs
Secondary aims
To explore if there is a correlation between postoperative dietary intake and length of hospital stay
To explore the relationship between comorbidity where reported and postoperative dietary intake according to dietary intake
To explore if in the development of postoperative complications infection pressure ulcer and VTE there is a correlation with postoperative dietary intake
Detailed Description:
A hip fracture is one of the most serious injuries that an older adult can sustain and with the current projections from the NHS Long Term Workforce plan of an increase in 85yrs by 55 and a current estimation of over 75000 hip fractures per year in England Northern Ireland and Wales with a 6-8 mortality rate at 1 year this warrants further research to improve outcomes and look at methods beyond the National Hip Fracture Database NHFD to ascertain what more can be done to optimise and improve this patient group Whilst ONS supplementation is used on an ad-hoc basis for patients with a high-risk malnutrition screening score of 2 using the MUST screening method such tools can lack sensitivity and accuracy and are also not developed to identify the development of malnutrition in-hospital
The proposed study for this protocol is an observation study of the dietary intake of older adult hip fracture patients The study will comprise of a weighed food diary commencing on day zero after surgery Potential participants that will be invited will be older adult hip fracture patients 60yrs with a confirmed hip fracture diagnosis that requires surgical repair The diary will consist of the researcher weighing the plate of food before and after the participants meal as this is regarded as a more accurate measure than relying on participant recall and does not place the participant under any additional stress
The researcher will not handle any food and plates will be placed on a digital scale Should a food have a specified weight - for example a yoghurt the weight on the product will be recorded Fluid intake will be recorded according to drinks served with meals and jugs of water per day After each meal the researcher will weigh the plate if it is a multiple item meal for example meat potatoes and vegetables the researcher will weigh the leftover components individually to ensure the validity of the weighed food method and to achieve the highest degree of accuracy possible The researcher will not be present nor disrupt the participant during their meal After their meal the researcher will ask the participant if they have had any additional snacks and observe if they have had any assistance with their meal Data will also be obtained regarding the times of meals the ratio of staff to patients and if any complications have developed
The aim of this study is to explore the postoperative dietary intake of older adult hip fracture patients until day three after surgery This builds on research where data on hip fracture patients was taken in relation to diet anthropometry and biochemical indices during inpatient stays Whilst the study was commenced in the second week post-surgery and compared against values at the week 1 admission as a baseline the researchers observed a longer length of stay drops in energy intake that coincided with a low BMI on admission and additionally referrals for high-risk patients that were not actioned
Subsequent studies have used varied interventions to explore postoperative nutrition however a weighed food diary has yet to be used in the immediate postoperative period which justifies the need for this study to explore nutritional intake as accurately as possible
The proposed study for this protocol is an observation study of the dietary intake of older adult hip fracture patients The study will comprise of a weighed food diary commencing on day zero after surgery Potential participants that will be invited will be older adult hip fracture patients 60yrs with a confirmed hip fracture diagnosis that requires surgical repair The diary will consist of the researcher weighing the plate of food before and after the participants meal as this is regarded as a more accurate measure than relying on participant recall and does not place the participant under any additional stress
The researcher will not handle any food and plates will be placed on a digital scale Should a food have a specified weight - for example a yoghurt the weight on the product will be recorded Fluid intake will be recorded according to drinks served with meals and jugs of water per day After each meal the researcher will weigh the plate if it is a multiple item meal for example meat potatoes and vegetables the researcher will weigh the leftover components individually to ensure the validity of the weighed food method and to achieve the highest degree of accuracy possible The researcher will not be present nor disrupt the participant during their meal After their meal the researcher will ask the participant if they have had any additional snacks and observe if they have had any assistance with their meal Data will also be obtained regarding the times of meals the ratio of staff to patients and if any complications have developed
The aim of this study is to explore the postoperative dietary intake of older adult hip fracture patients until day three after surgery This builds on research where data on hip fracture patients was taken in relation to diet anthropometry and biochemical indices during inpatient stays Whilst the study was commenced in the second week post-surgery and compared against values at the week 1 admission as a baseline the researchers observed a longer length of stay drops in energy intake that coincided with a low BMI on admission and additionally referrals for high-risk patients that were not actioned
Subsequent studies have used varied interventions to explore postoperative nutrition however a weighed food diary has yet to be used in the immediate postoperative period which justifies the need for this study to explore nutritional intake as accurately as possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None