Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12622001044718
Ethics application status
Approved
Date submitted
21/07/2022
Date registered
27/07/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
27/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Home Enteral Nutrition Performance (HELP) study: the health, wellbeing, and nutritional outcomes of long-term enterally fed patients
Scientific title
The health, wellbeing, and nutritional outcomes of long-term enterally fed patients.
Secondary ID [1] 307635 0
None
Universal Trial Number (UTN)
U1111-1280-8241
Trial acronym
HELP study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Longterm enteral feeding 327130 0
Nutrient deficiencies 327131 0
Quality of care 327132 0
Equitable access 327149 0
Condition category
Condition code
Diet and Nutrition 324270 324270 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Condition observed: Adult patients (>18 years) who are being tube fed (enteral feeding) at home under active care for more than 4 weeks. All assessments will be carried out in person at the participants home or at the community base clinic, unless otherwise specified.
- Blood sample collection to determine micronutrient deficiencies (vitamin B12, Folate,
selenium, Vitamin D, Copper, Zinc, Iron) - one sample collected independently from
other measures - 15 minutes maximum per participant. Blood samples will be collected
by a phlebotomist and one research team member will oversee the process;
- Dietary intake - one in-person 24-hour dietary recall,
- Quality of life assessment – 2 questionnaires, 1 generic,1 condition specific, and
exploratory interview questions,
- Equity of care assessment – 1 questionnaire, and exploratory interview questions,
- Physical examination of physical signs and symptoms of nutrient deficiencies. A
member of the research team will conduct a routine physical exam using a self-
compiled set of physical measures to indicate nutritional deficiency.
The in-person 24h-recall, 3 questionnaires and physical examination will all be completed in
a 45-60 minute session by a member of the research team;
- Four further 24-hour dietary recalls will be conducted over the phone by a research
team member over the next 3 weeks, taking about 10-15 minutes each
- the Charleston’s comorbidity evaluation – will be conducted over the phone following
the final 24h-recall, taking a maximum of 5 minutes.
Healthcare staff perceptions on the quality of care, patient satisfaction and equity of care will be collected during a minimum of three focus groups (4-8 members) moderated by one research team member, taking about 1-1.5 hours each.
Intervention code [1] 324086 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332081 0
To investigate micronutrient intakes of Home Enteral Nutrition (HEN) patients using a 24h-recall method to determine intake of vitamin D, vitamin B12, folate, Fe, Cu, Zn, and Se from food / feed assessed with FoodWorks Professional 9; Xyris Software.
Timepoint [1] 332081 0
Five data collection time points for 24h-recall namely one at baseline (1), week 1 (1), week 2 (2), week 3 (1).,
Primary outcome [2] 332082 0
Determine the effect of micronutrient intakes on nutritional status using biomarker assessments from one blood sample that will be analysed by a fully accredited laboratory and a physical examination for signs of physical nutrient deficiency using a checklist that was specifically compiled for this study.
Timepoint [2] 332082 0
One timepoint (baseline)
Primary outcome [3] 332083 0
To investigate the impact of the HEN service from a patient perspective on their experience of their overall quality of life using the World Health Organization Quality of Life Questionnaire; New Zealand (NZ) Version (NZWHOQOL-BREF).
Timepoint [3] 332083 0
One timepoint (baseline)
Secondary outcome [1] 412132 0
Patient's perceptions on their satisfaction of dietary quality using individual exploratory interviews
Timepoint [1] 412132 0
One timepoint (baseline)
Secondary outcome [2] 412133 0
Health care staff (community dietitians, district nursing staff) perceptions on the patient satisfaction regarding their care (including dietary quality as relevant per staff grouping) for the long-term HEN patients in their care by using focus group discussions (4-6 participants) to collect qualitative data.
Timepoint [2] 412133 0
Three (minimum) focus groups over the study period to reach data saturation
Secondary outcome [3] 412134 0
To investigate the average timeframe of developing nutritional deficiencies when on Home Enteral feeding by using a composite of patient history timeframe on HEN from the demographic questionnaire, related co-morbidities using the Charlston comorbidity Index, biomarker deficiencies using blood samples analysed by an accredited laboratory, and physical signs of nutrient deficiencies by physical examination by a member of the research team.
Timepoint [3] 412134 0
One timepoint (baseline)
Secondary outcome [4] 412192 0
Primary outcome
To investigate macronutrient intakes of Home Enteral Nutrition (HEN) patients using a 24h-recall method to determine intake of macronutrients and energy from food / feed assessed with FoodWorks Professional 9; Xyris Software.
Timepoint [4] 412192 0
Five data collection time points for 24h-recall namely one at baseline (1), week 1 (1), week 2 (2), week 3 (1).,
Secondary outcome [5] 412193 0
Primary outcome
To investigate the impact of the HEN service from a patient perspective on their experience of equity of care by assessing their access to equitable, culturally safe care using the NZ District Health Board patient-experience survey.
Timepoint [5] 412193 0
One timepoint (baseline).
Secondary outcome [6] 412194 0
Primary outcome
To investigate the impact of the HEN service from a patient perspective on their experience of their HEN specific quality of life using the health-related quality of life specific to HEN questionnaire (NutriQoL®).
Timepoint [6] 412194 0
One timepoint (baseline)
Secondary outcome [7] 412195 0
Patient's perceptions on their satisfaction of care using individual exploratory interviews
Timepoint [7] 412195 0
One timepoint (baseline)
Secondary outcome [8] 412196 0
Health care staff (community dietitians, district nursing staff) perceptions on equity of care for the long-term HEN patients in their care by using focus group discussions (4-6 participants) to collect qualitative data.
Timepoint [8] 412196 0
Three (minimum) focus groups over the study period to reach data saturation

Eligibility
Key inclusion criteria
HEN patients under Counties Manukau care that are 18 years or older; receiving any form of enteral tube feeding long-term (>4 weeks) .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All HEN patients receiving supplemental parenteral nutrition; palliative HEN patients and patients unable to give a blood sample

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size was calculated based on the Kang et al. study with an estimated prevalence of Iron, Copper, Zinc and selenium deficiencies of 22.7%, 4.5%, 26.6% and 9.1% respectively.
Based on the prevalence of Iron as the most interested nutrient, a power calculation identified that we need a minimum sample size of 66 to estimate deficiency of 22.7% with a 10% level of precision and 95% confidence interval.
Nutritional intake will be analysed using FoodWorks dietary analysis software (FoodWorks professional 9; Xyris Software, Australia; New Zealand Food Composition database) for the selected micronutrients.
Descriptive data will be summarised as the mean and standard deviation (SD) or median with interquartile range for the continuous variables based on current micronutrient intake and biomarker analysis and categorical variables will be expressed as frequency and percentage of the subjects. Pearson’s or spearman’s correlation coefficients will be used to measure the strength of the relationship between trace element levels in the blood and the nutritional parameters in the micronutrient intake.
Statistical analysis will be performed using SPSS and SAS version 9.4. Comparison between groups will be made using repeated measure ANOVA and General linear model (GLM), followed by the Bonferroni method of the post-hoc analysis for continuous data and Fisher’s exact test for categorical data.
Deficiencies in the trace elements will be reported as proportions and 95% confidence intervals.
Patient quality of life will be reported as a mean score for each survey with their standard deviation.
Patient experience survey will be reported as counts and proportions. Correlations will be carried out to determine which items are strongly correlated. P values less than 0.05 will be considered as statistically significant.
Thematic analysis of transcribed interview data via NVivo software will be used for analysing both the focus group and individual exploratory interview data.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2022
Actual
28/07/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
19/10/2022
Date of last data collection
Anticipated
31/10/2022
Actual
11/11/2022
Sample size
Target
66
Accrual to date
Final
43
Recruitment outside Australia
Country [1] 24914 0
New Zealand
State/province [1] 24914 0
Auckland

Funding & Sponsors
Funding source category [1] 311899 0
University
Name [1] 311899 0
Massey University Research Fund
Country [1] 311899 0
New Zealand
Funding source category [2] 311901 0
Hospital
Name [2] 311901 0
Counties Manukau Tupu fund – Maataatupu grant
Country [2] 311901 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University (East precinct),
Albany Express Highway (SH17),
Albany,
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 313380 0
Hospital
Name [1] 313380 0
Counties Manukau, NZ Health
Address [1] 313380 0
Level 1, Ko Awatea Building, Middlemore hospital,
100 Hospital Road,
Auckland 2025,
Country [1] 313380 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311334 0
Massey University Human Ethics Southern A Committee
Ethics committee address [1] 311334 0
Ethics committee country [1] 311334 0
New Zealand
Date submitted for ethics approval [1] 311334 0
29/03/2022
Approval date [1] 311334 0
07/07/2022
Ethics approval number [1] 311334 0
SOA22/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120754 0
Prof Rozanne Kruger
Address 120754 0
School of Sport, Exercise and Nutrition
Massey University, Auckland campus (East precinct),
Albany Express Highway (SH17),
Albany,
Auckland 0632
Country 120754 0
New Zealand
Phone 120754 0
+64 9 213 6661
Fax 120754 0
n/a
Email 120754 0
[email protected]
Contact person for public queries
Name 120755 0
Rozanne Kruger
Address 120755 0
School of Sport, Exercise and Nutrition
Massey University, Auckland campus (East precinct),
Albany Express Highway (SH17),
Albany,
Auckland 0632
Country 120755 0
New Zealand
Phone 120755 0
+64 9 213 6661
Fax 120755 0
n/a
Email 120755 0
[email protected]
Contact person for scientific queries
Name 120756 0
Rozanne Kruger
Address 120756 0
School of Sport, Exercise and Nutrition
Massey University, Auckland campus (East precinct),
Albany Express Highway (SH17),
Albany,
Auckland 0632
Country 120756 0
New Zealand
Phone 120756 0
+64 9 213 6661
Fax 120756 0
n/a
Email 120756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16715Ethical approval  [email protected] 384424-(Uploaded-21-07-2022-20-57-01)-Study-related document.pdf



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.