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Trial registered on ANZCTR


Registration number
ACTRN12617001084370
Ethics application status
Approved
Date submitted
21/07/2017
Date registered
26/07/2017
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of using a text message intervention to enhance standard nutrition care in the haemodialysis population
Scientific title
Feasibility of using a text message intervention to enhance standard nutrition care in the haemodialysis population (KIDNEYTEXT)
Secondary ID [1] 292468 0
Nil known
Universal Trial Number (UTN)
U1111-1199-4881
Trial acronym
KIDNEYTEXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodialysis-dependent end-stage kidney disease 304085 0
Condition category
Condition code
Renal and Urogenital 303420 303420 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: KIDNEYTEXT Intervention plus usual care

Materials and mode of delivery: Mobile phone text messages containing dietary and lifestyle advice will be sent to intervention participants. Text message content will include information pertaining to renal-specific dietary needs (potassium, phosphorus, sodium, and fluid), general healthy eating, physical activity promotion, medication reminders and symptom identification.

Procedure: Mobile phone text messages will be sent three times a week to intervention group participants. Text messages are aimed at supporting a dietary pattern that reduces dietary electrolytes and fluid, whilst adhering to Australian Dietary Guidelines. Using a patient-centred approach, intervention delivery is based on empirical evidence that supports a focus on self-management and underpinned by behaviour change theory.

Mode of delivery and number of contacts: Phase 1, Week 0-13: Three mobile phone text messages per week will be sent. These messages will be semi-individualised to a participants’ dietary intake and electrolyte biochemistry (serum potassium, serum phosphate) and fluid status (interdialytic weight gains). Phase 2, week 14-26: Three mobile phone text messages per week will be sent. These messages will be focused on providing general healthy eating, activity promotion, medication reminders and symptom identification. Messages will be practical in nature, less than 160 characters in length and will be generic for varying age and sex.

Who and Location: Mobile phone text messages will be sent automatically using an automatic software program that has been developed for use in clinical trials at Westmead Hospital. Text messages will be sent at random times of the day on specified days of the week.

Fidelity: Prior to study commencement, a bank of 190 messages will be developed based on scientific literature and multidisciplinary expert review and consumer feedback.
Intervention code [1] 298651 0
Behaviour
Intervention code [2] 298688 0
Treatment: Other
Comparator / control treatment
Usual care. Participants randomised to usual care will continue to receive standard nutrition education. Usual care includes referral to a renal dietitian for initial and ongoing review of patients, however this occurs at differing frequencies across dialysis units.
Control group
Active

Outcomes
Primary outcome [1] 302807 0
Feasibility
The primary endpoint of this trial will be a composite outcome using quantitative and qualitative analysis of feasibility. We will measure feasibility using::
• Adherence to dietary recommendations. This will be measured using the 24-hour pass methodology to assess dietary intake with particular focus on renal dietary components: protein, potassium, phosphorous and sodium intake compared to renal dietary guideline recommendations.
• Recruitment rate
• Drop-out rate
• Participant satisfaction (using a 5 point likert scale)
• Semi-structured interviews to explore adherence to study procedures, rates of self-monitoring, decision making, problem solving and behaviour change (measured in group B only)
Timepoint [1] 302807 0
3 and 6 months post commencement of intervention
Secondary outcome [1] 337078 0
Compare serum electrolytes (potassium, phosphate)
Timepoint [1] 337078 0
3 and 6 months post commencement of intervention
Secondary outcome [2] 337079 0
Compare interdialytic weight gains (average of the previous 3 haemodialysis sessions)
Timepoint [2] 337079 0
3 and 6 months post commencement of intervention
Secondary outcome [3] 337080 0
Compare nutritional status (measured using the Patient-Generated Subjective Global Assessment tool)
Timepoint [3] 337080 0
6 months post commencement of intervention
Secondary outcome [4] 337081 0
Compare quality of life scores (measured using EQ-5D-5L)
Timepoint [4] 337081 0
3 and 6 months post commencement of intervention
Secondary outcome [5] 337082 0
Compare dietary quality measured using the Australian Healthy Eating Index and the mean change in the intake of renal specific dietary components (potassium, phosphorus, sodium, fluid) compared to evidence based dietary guidelines for haemodialysis. This will be measured using the 24-hour pass methodology to assess dietary intake.
Timepoint [5] 337082 0
3 and 6 months post commencement of intervention
Secondary outcome [6] 337083 0
Health-related cost-analysis (including cost of intervention, healthcare utilisation, health utility) will be measured using patient-reported healthcare-related appointments and data linkage to healthcare records.
Timepoint [6] 337083 0
6 months post commencement of intervention
Secondary outcome [7] 337084 0
Compare blood pressure control using pre and post dialysis blood pressures (averaged from the previous 3 dialysis sessions)
Timepoint [7] 337084 0
6 months post commencement of intervention
Secondary outcome [8] 337085 0
Compare glycaemic control measured using glycated haemoglobin levels (HbA1c) (subgroup analysis for patients with diabetes)
Timepoint [8] 337085 0
6 months post commencement of intervention
Secondary outcome [9] 337086 0
Compare serum parathyroid hormone
Timepoint [9] 337086 0
6 months post commencement of intervention
Secondary outcome [10] 337218 0
Compare serum urea level
Timepoint [10] 337218 0
6 months post commencement of the intervention
Secondary outcome [11] 337219 0
Compare serum bicarbonate levels
Timepoint [11] 337219 0
6 months post intervention commencement
Secondary outcome [12] 337220 0
Compare serum albumin levels
Timepoint [12] 337220 0
6 months post commencement of the intervention

Eligibility
Key inclusion criteria
a) Patients receiving maintenance haemodialysis (e.g. for at least 3 months) who are able to provide informed consent
b) Patients who are able to read and understand English
c) Patients who possess a mobile phone to utilise text message technology
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Patients receiving maintenance haemodialysis who are acutely unwell (e.g. septic)
b) Patients with a life expectancy of less than 12 months
c) Patients who are not expected to be on haemodialysis for the forthcoming 6 months (e.g. change of dialysis modality or transplantation)
d) Women who are pregnant or breastfeeding
e) Significant cognitive impairment (e.g. diagnosed dementia) or intellectual disability

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed centrally by the text messaging software program and allocation concealed from the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation (2:1); Stratified by study centre using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
4/12/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
16/04/2018
Date of last data collection
Anticipated
31/08/2018
Actual
27/11/2018
Sample size
Target
130
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8561 0
Westmead Hospital - Westmead
Recruitment hospital [2] 8562 0
St George Hospital - Kogarah
Recruitment hospital [3] 8575 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [4] 8576 0
Blacktown Hospital - Blacktown
Recruitment hospital [5] 8577 0
The Sutherland Hospital - Caringbah
Recruitment hospital [6] 13926 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 16665 0
2145 - Westmead
Recruitment postcode(s) [2] 16666 0
2217 - Kogarah
Recruitment postcode(s) [3] 16681 0
2144 - Auburn
Recruitment postcode(s) [4] 16682 0
2148 - Blacktown
Recruitment postcode(s) [5] 16683 0
2229 - Caringbah
Recruitment postcode(s) [6] 26696 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 297033 0
University
Name [1] 297033 0
The University of Sydney
Country [1] 297033 0
Australia
Funding source category [2] 297035 0
Other Collaborative groups
Name [2] 297035 0
Better Evidence and Translation in Chronic Kidney Disease
Country [2] 297035 0
Australia
Funding source category [3] 302971 0
Government body
Name [3] 302971 0
National Health and Medical Research Council (NHMRC)
Country [3] 302971 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Vincent Lee
Address
Renal Department, Westmead Hospital, Darcy Road, Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 296039 0
None
Name [1] 296039 0
Address [1] 296039 0
Country [1] 296039 0
Other collaborator category [1] 279647 0
Individual
Name [1] 279647 0
Ms Jessica Stevenson
Address [1] 279647 0
The Centre for Kidney Research, Westmead Institute for Medical Research, 179 Hawkesbury Rd, Westmead, NSW 2145
Country [1] 279647 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298218 0
Western Sydney Local Health District Human Research and Ethics Committee
Ethics committee address [1] 298218 0
Westmead Research Office
Research & Education Network
PO Box 533
Wentworthville NSW 2145
Ethics committee country [1] 298218 0
Australia
Date submitted for ethics approval [1] 298218 0
Approval date [1] 298218 0
17/02/2017
Ethics approval number [1] 298218 0
HREC/16/WMEAD/396

Summary
Brief summary
Chronic Kidney Disease (CKD) is increasingly being recognised as a global public health problem with increasing incidence and prevalence, contributing to significant morbidity and mortality. Dietary intervention is a pivotal aspect of care for people with all stages of CKD and can significantly improve the morbidity and mortality of these patients. However, it is a complex diet that is frequently met with resistance from patients. Improving patient engagement and education regarding diet and lifestyle is vital to improve patient outcomes and reduce the burden on the healthcare system. Using mobile phone technology, such as text messaging, offers a novel way of engaging with patients on dialysis. This randomised controlled trial aims to determine the feasibility and clinical impact of using text messages to improve nutrition-related behaviours in the haemodialysis population.

The primary aim of this study is to assess of the feasibility of using a mobile phone text message intervention to improve dietary adherence in a haemodialysis population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76378 0
A/Prof Vincent Lee
Address 76378 0
Renal Department, Westmead Hospital, Darcy Road, Westmead, NSW 2145
Country 76378 0
Australia
Phone 76378 0
+61 2 98456962
Fax 76378 0
Email 76378 0
[email protected]
Contact person for public queries
Name 76379 0
Jessica Stevenson
Address 76379 0
Centre for Kidney Research, Westmead Institute for Medical Research, 179 Hawkesbury Rd Westmead NSW 2145
Country 76379 0
Australia
Phone 76379 0
+61 2 9845 0120
Fax 76379 0
Email 76379 0
[email protected]
Contact person for scientific queries
Name 76380 0
Vincent Lee
Address 76380 0
Renal Department, Westmead Hospital, Darcy Road, Westmead, NSW 2145
Country 76380 0
Australia
Phone 76380 0
+61 2 98456962
Fax 76380 0
Email 76380 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
Sharing of de-identified data may be requested, the sharing of which will be considered.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2229Statistical analysis plan    373330-(Uploaded-30-05-2019-12-11-34)-Study-related document.pdf
2262Study protocol    Study protocol available at: https://bmjopen.bmj.c... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTargeted, structured text messaging to improve dietary and lifestyle behaviours for people on maintenance haemodialysis (KIDNEYTEXT): Study protocol for a randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-023545
EmbaseA Text Messaging Intervention for Dietary Behaviors for People Receiving Maintenance Hemodialysis: A Feasibility Study of KIDNEYTEXT.2021https://dx.doi.org/10.1053/j.ajkd.2020.11.015
N.B. These documents automatically identified may not have been verified by the study sponsor.