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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06451679
Other study ID # 2024 Jan 19539 LLOYD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 13, 2024
Est. completion date July 31, 2024

Study information

Verified date June 2024
Source Teesside University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 (kJ/kcal) 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.


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 75,000 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 participant's 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Adults >60yrs with a confirmed diagnosis of a hip fracture requiring surgical repair. Exclusion Criteria: - Pathological hip fractures - Traumatic hip fractures - such as a road traffic collision injury. - Patients that cannot speak English due to the need for informed consent. - Patients undergoing oncologic treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
Observational prospective study

Locations

Country Name City State
United Kingdom Teesside University Middlesbrough

Sponsors (1)

Lead Sponsor Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs. REE in kJ/kcal 3 days
Secondary The Correlation between comorbidity (where reported) and postoperative dietary intake, according to dietary intake. Correlation between comorbidity and dietary intake From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Secondary Correlation between Postoperative complications (infection, pressure ulcer and VTE), and postoperative dietary intake. Link between complications and dietary intake From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Secondary Postoperative dietary intake From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Secondary The length of hospital stay. From day of surgery until discharge from acute hospital stay, assessed up to 3 months
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