NCT06451679

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 (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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 3, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

Hip fracturePerioperativeSurgicalFood diaryNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The Correlation between comorbidity (where reported) and postoperative dietary intake, according to dietary intake.

    From day of surgery until discharge from acute hospital stay, assessed up to 3 months

  • Correlation between Postoperative complications (infection, pressure ulcer and VTE), and postoperative dietary intake.

    From day of surgery until discharge from acute hospital stay, assessed up to 3 months

  • Postoperative dietary intake

    From day of surgery until discharge from acute hospital stay, assessed up to 3 months

  • The length of hospital stay.

    From day of surgery until discharge from acute hospital stay, assessed up to 3 months

Interventions

Observational prospective study

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective older adult hip fracture patients aged 60 and over at the point of admission.

You may qualify if:

  • Adults \>60yrs with a confirmed diagnosis of a hip fracture requiring surgical repair.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teesside University

Middlesbrough, TS1 3BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hip FracturesMalnutritionPostoperative Complications

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 11, 2024

Study Start

May 13, 2024

Primary Completion

July 31, 2024

Study Completion

August 31, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations