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.
