Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000588392
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
26/04/2017
Date last updated
26/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating pre-operative carbohydrate supplementation in hip fracture patients - A feasibility study for a randomised control trial
Scientific title
Is a randomised control trial to evaluate the impact of pre-operative carbohydrate supplementation on patient outcomes feasible in acute hip fracture patients admitted to The Prince Charles Hospital Hip Fracture Unit?
Secondary ID [1] 291667 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHOinNOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture 302823 0
Malnutrition 302824 0
Insulin Resistance 302825 0
Condition category
Condition code
Surgery 302318 302318 0 0
Other surgery
Diet and Nutrition 302319 302319 0 0
Other diet and nutrition disorders
Injuries and Accidents 302346 302346 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evaluating the provision of pre-operative carbohydrate drinks in the acute hip fracture setting: A feasibility study for a randomised control trial
Intervention: Carbohydrate supplement (0.5kcal/ml, clear fluid liquid; 50.4g carbohydrate (maltodextrin) per 400mL serve.)
400mL carbohydrate supplement to be consumed orally within 1hour, 2-3 hours before surgery. Single dosage only and consumption recorded by the administrating staff member.
Intervention code [1] 297754 0
Treatment: Other
Comparator / control treatment
Control arm will consist of standard peri-operative care - patients fasting from mid night.

pre, intra and post operative standardised care pathways align with the Australian and New Zealand Guideline for Hip Fracture Care - Improving Outcomes in Hip Fracture management of Adults guideline
Control group
Active

Outcomes
Primary outcome [1] 301725 0
Recruitment rate of participants
Timepoint [1] 301725 0
when sample size is reached
Primary outcome [2] 301727 0
Integration success of the intervention into routine clinical practice (success of feasbility study for standard care use; composite outcome)
Review of medication charts to determine correctly prescribed and administered supplements (measured by script)
Review of OT schedule and changes to OT schedule as a result of supplement consumption (measured by mins delayed)
Timepoint [2] 301727 0
when sample size is reached
Primary outcome [3] 301768 0
Adherence with prescribed carbohydrate supplement.
Documented by administering staff member
Timepoint [3] 301768 0
DAY 1 post surgery
Secondary outcome [1] 333693 0
Patient perceived quality of life using the EQ-5D tool
Timepoint [1] 333693 0
DAY 2 post operative and at 10 week fracture clinic
Secondary outcome [2] 333802 0
Unfavorable outcomes - incidence of aspiration (documented in medical notes)
Timepoint [2] 333802 0
from DAY 0- DAY 5
Secondary outcome [3] 334142 0
Hospital Length of Stay - review of medical notes
Timepoint [3] 334142 0
10 week follow up
Secondary outcome [4] 334143 0
Patient functional status (DEMMI score)
Timepoint [4] 334143 0
Day 1/2 + 10 week follow up
Secondary outcome [5] 334144 0
Supplement intolerance and subsequent nausea/vomiting- review of consumption + antiemetic use + episodes of vomiting collected from medical chart/medication list
Timepoint [5] 334144 0
Day 0- Day 5

Eligibility
Key inclusion criteria
- fractured neck of femur
- community dwelling prior to admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- non operative managment
- diabetes requiring insulin
- oral feeding aversion or carbohydrate intolerance
- admission for supported accomodation including nursing home and residential aged care facilities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
32 participants will be required to determine feasibility
descriptive statistics will be presented for all variables. Univariable associations between control and intervention groups analysed by Chi square as well as thematic analysis for non-consent, consumption or delivery concerns

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7822 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 15755 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 296166 0
Charities/Societies/Foundations
Name [1] 296166 0
The Prince Charles Hospital Foundation - Emerging Researcher Grant
Country [1] 296166 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital, Hip Fracture Unit
Address
The Prince Charles Hospital
Rode Road, Chermside QLD 4053
Country
Australia
Secondary sponsor category [1] 295068 0
None
Name [1] 295068 0
Address [1] 295068 0
Country [1] 295068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297411 0
The Prince Charles Hopsital
Ethics committee address [1] 297411 0
The Prince Charles Hospital
Rode Road, Chermside QLD 4053
Ethics committee country [1] 297411 0
Australia
Date submitted for ethics approval [1] 297411 0
09/03/2017
Approval date [1] 297411 0
04/04/2017
Ethics approval number [1] 297411 0
HREC/17QPCH/90

Summary
Brief summary
This feasibility trial will evaluate the provision of pre-operative carbohydrate drinks in the acute hip fracture setting to inform feasible and clinically relevant reserach protocol to enable a larger efficacy study to answer the research question.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73954 0
Ms Sally Fraser
Address 73954 0
The Prince Charles Hospital
Hip Fracture Unit, Level 2
Rode Road, Chermside QLD 4032
Country 73954 0
Australia
Phone 73954 0
61 7 3139 5583
Fax 73954 0
Email 73954 0
[email protected]
Contact person for public queries
Name 73955 0
Ms Sally Fraser
Address 73955 0
The Prince Charles Hospital
Nutrition and Dietetics Department, Building 14
Rode Road, Chermside QLD 4035
Country 73955 0
Australia
Phone 73955 0
61731395583
Fax 73955 0
Email 73955 0
[email protected]
Contact person for scientific queries
Name 73956 0
Ms Sally Fraser
Address 73956 0
The Prince Charles Hospital
Nutrition and Dietetics Department, Building 14
Rode Road, Chermside QLD 4035
Country 73956 0
Australia
Phone 73956 0
61731395583
Fax 73956 0
Email 73956 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.