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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]

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

Condition category

Condition code

Renal and Urogenital

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]

Behaviour

Intervention code [2]

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]

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]

3 and 6 months post commencement of intervention

Secondary outcome [1]

Compare serum electrolytes (potassium, phosphate)

Timepoint [1]

3 and 6 months post commencement of intervention

Secondary outcome [2]

Compare interdialytic weight gains (average of the previous 3 haemodialysis sessions)

Timepoint [2]

3 and 6 months post commencement of intervention

Secondary outcome [3]

Compare nutritional status (measured using the Patient-Generated Subjective Global Assessment tool)

Timepoint [3]

6 months post commencement of intervention

Secondary outcome [4]

Compare quality of life scores (measured using EQ-5D-5L)

Timepoint [4]

3 and 6 months post commencement of intervention

Secondary outcome [5]

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]

3 and 6 months post commencement of intervention

Secondary outcome [6]

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]

6 months post commencement of intervention

Secondary outcome [7]

Compare blood pressure control using pre and post dialysis blood pressures (averaged from the previous 3 dialysis sessions)

Timepoint [7]

6 months post commencement of intervention

Secondary outcome [8]

Compare glycaemic control measured using glycated haemoglobin levels (HbA1c) (subgroup analysis for patients with diabetes)

Timepoint [8]

6 months post commencement of intervention

Secondary outcome [9]

Compare serum parathyroid hormone

Timepoint [9]

6 months post commencement of intervention

Secondary outcome [10]

Compare serum urea level

Timepoint [10]

6 months post commencement of the intervention

Secondary outcome [11]

Compare serum bicarbonate levels

Timepoint [11]

6 months post intervention commencement

Secondary outcome [12]

Compare serum albumin levels

Timepoint [12]

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?

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]

Westmead Hospital - Westmead

Recruitment hospital [2]

St George Hospital - Kogarah

Recruitment hospital [3]

Auburn Hospital & Community Health Services - Auburn

Recruitment hospital [4]

Blacktown Hospital - Blacktown

Recruitment hospital [5]

The Sutherland Hospital - Caringbah

Recruitment hospital [6]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

2217 - Kogarah

Recruitment postcode(s) [3]

2144 - Auburn

Recruitment postcode(s) [4]

2148 - Blacktown

Recruitment postcode(s) [5]

2229 - Caringbah

Recruitment postcode(s) [6]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Camperdown NSW 2006

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Better Evidence and Translation in Chronic Kidney Disease

Address [2]

Centre for Kidney Research, Westmead Institute for Medical Research, 179 Hawkesbury Rd, Westmead, NSW 2145

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

National Health and Medical Research Council (NHMRC)

Address [3]

16 Marcus Clarke St, Canberra ACT 2601

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Ms Jessica Stevenson

Address [1]

The Centre for Kidney Research, Westmead Institute for Medical Research, 179 Hawkesbury Rd, Westmead, NSW 2145

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research and Ethics Committee

Ethics committee address [1]

Westmead Research Office
Research & Education Network
PO Box 533
Wentworthville NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/02/2017

Ethics approval number [1]

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

A/Prof Vincent Lee

Address

Renal Department, Westmead Hospital, Darcy Road, Westmead, NSW 2145

Country

Australia

Phone

+61 2 98456962

Fax

[email protected]

Contact person for public queries

Name

Jessica Stevenson

Address

Centre for Kidney Research, Westmead Institute for Medical Research, 179 Hawkesbury Rd Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 0120

Fax

[email protected]

Contact person for scientific queries

Name

Vincent Lee

Address

Renal Department, Westmead Hospital, Darcy Road, Westmead, NSW 2145

Country

Australia

Phone

+61 2 98456962

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
2229	Statistical analysis plan					373330-(Uploaded-30-05-2019-12-11-34)-Study-related document.pdf
2262	Study 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

Source	Title	Year of Publication	DOI
Embase	Targeted, structured text messaging to improve dietary and lifestyle behaviours for people on maintenance haemodialysis (KIDNEYTEXT): Study protocol for a randomised controlled trial.	2019	https://dx.doi.org/10.1136/bmjopen-2018-023545
Embase	A Text Messaging Intervention for Dietary Behaviors for People Receiving Maintenance Hemodialysis: A Feasibility Study of KIDNEYTEXT.	2021	https://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.

Trial Review

Documents added manually

Documents added automatically