Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000746831
Ethics application status
Approved
Date submitted
9/04/2021
Date registered
11/06/2021
Date last updated
20/12/2024
Date data sharing statement initially provided
11/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does targeted dietary advice via telecommunications (video, phone and text) reduce blood phosphate levels in patients with kidney failure on dialysis?
Scientific title
TELEnutrition and KIdNey hEalth – a randomised controlled trial comparing the effect of digital health to standard care on serum phoSphate control in patients on dIalysiS
Secondary ID [1] 303922 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The TELEKINESIS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease 321508 0
Hyperphosphatemia 321509 0
Condition category
Condition code
Renal and Urogenital 319260 319260 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to recruit participants in Australia who are receiving maintenance dialysis. They will be randomly assigned to either a usual dietetic care group or dietary intervention group. The usual care group will continue to receive standard face to face/telemedicine care provided by the relevant hospital or dialysis unit dietitian. The intervention group will receive standard care plus intensive phosphate lowering education from the research dietitian via identification of high bioavailable dietary sources (from nutritional analysis with software program Foodworks), phosphate binder education and food preparation instruction. All instructions will be designed specifically for this trial. This will be done via telenutrition (video and/or phone determined by participant) at baseline (1 x 45 minute), another within one week of the baseline visit (1 x 45 minute) and then will be supported with weekly targeted messages and infographics via a specifically designed App over the next three month period. Messages will be unidirectional, (i.e., one-way with no response required from participants). Content of the messages will include advice, information, reminders, and motivation to support improved serum phosphate levels and quality of life. Messages will be personalised based on baseline dietary intake (from FFQ) and monthly serum phosphate blood tests (normal practice) to three months. Appropriate software will monitor delivery of messages to confirm delivery to participants. The duration of the study (usual care and intervention) is three months, with measurements of serum phosphate, dietary intake (FFQ) and pill burden undertaken at baseline and at the end of the study period. The interviews will be conducted by renal dietitians.
Intervention code [1] 320230 0
Lifestyle
Intervention code [2] 320504 0
Treatment: Other
Comparator / control treatment
The control group will be those receiving normal care ( one off 30 - 45 minute dietary advice session) by the renal dietitian at their hospital or dialysis unit.
Control group
Active

Outcomes
Primary outcome [1] 327140 0
The primary outcome will be to determine if dietary phosphate intervention via telemedicine can reduce serum phosphate levels. This will be measured via a composite of adherence to dietary recommendations using the phosphate specific food frequency questionnaire (FFQ), serum phosphate levels and pill burden questionnaire. The FFQ and pill burden questionnaire have been designed specifically for this trial.
Timepoint [1] 327140 0
At baseline (initial interview), 3 months and 6 months post baseline,
Secondary outcome [1] 393943 0
Secondary outcome will be to assess if there is any change in consumption of ultra processed foods containing phosphate additives. This will be assessed using the participants FFQ and analysed with software program Foodworks.
Timepoint [1] 393943 0
Baseline (initial interview) 3 and 6 months post intervention commencement.
Secondary outcome [2] 443398 0
Acceptability of App (intervention group only) quality of life (EQ-5D-5L) and patient knowledge and ability to self manage (PAM) will also be measured.
Timepoint [2] 443398 0
This will be done at month 3 for acceptability of App and at month 3 and 6 for quality of life and PAM.

Eligibility
Key inclusion criteria
On dialysis (peritoneal dialysis or haemodialysis (home or facility-based)) for at least 3 months who are able to provide informed consent.
Age >= 18 years
Patients who are able to read and understand English.
Patients who have access to a mobile phone with text message tachnology.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitalisation within the last 1 month
Serious intercurrent illness within the last 1 month
Unable to complete the FFQ e.g. patients with dementia, cognitive deficit and/or language barrier
Patients who are not expected to be dialysis for the forthcoming 3 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will occur using computer-generated numbers and patients will be notified by phone or text.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised
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
The sample size was selected by statistician to give 80% power to detect an effect size f=0.19 difference in a repeated measures ANOVA or linear mixed model comparing 2 groups across 2 timepoints with alpha=0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
27/06/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
166
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 19083 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 19084 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 19085 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 24638 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 24639 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 24641 0
Western Hospital - Footscray - Footscray
Recruitment hospital [7] 24642 0
St Vincent's Hospital (Lismore) - Lismore
Recruitment hospital [8] 24643 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [9] 24644 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 24645 0
John Hunter Hospital - New Lambton
Recruitment hospital [11] 24646 0
Wollongong Hospital - Wollongong
Recruitment hospital [12] 24647 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [13] 24648 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [14] 24649 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [15] 24650 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [16] 24651 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [17] 26523 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 33640 0
6009 - Nedlands
Recruitment postcode(s) [2] 33641 0
6000 - Perth
Recruitment postcode(s) [3] 33642 0
6150 - Murdoch
Recruitment postcode(s) [4] 40249 0
5000 - Adelaide
Recruitment postcode(s) [5] 40250 0
5042 - Bedford Park
Recruitment postcode(s) [6] 40252 0
3011 - Footscray
Recruitment postcode(s) [7] 40253 0
2480 - Lismore
Recruitment postcode(s) [8] 40254 0
3081 - Heidelberg West
Recruitment postcode(s) [9] 40255 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 40256 0
2305 - New Lambton
Recruitment postcode(s) [11] 40257 0
2500 - Wollongong
Recruitment postcode(s) [12] 40258 0
2560 - Campbelltown
Recruitment postcode(s) [13] 40259 0
2340 - Tamworth
Recruitment postcode(s) [14] 40260 0
0870 - Alice Springs
Recruitment postcode(s) [15] 40261 0
0810 - Tiwi
Recruitment postcode(s) [16] 40262 0
4029 - Herston
Recruitment postcode(s) [17] 42564 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 308308 0
Charities/Societies/Foundations
Name [1] 308308 0
Charlies Research Foundation
Country [1] 308308 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Country
Australia
Secondary sponsor category [1] 309115 0
None
Name [1] 309115 0
n/a
Country [1] 309115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308284 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Ethics Committee
Ethics committee address [1] 308284 0
Ethics committee country [1] 308284 0
Australia
Date submitted for ethics approval [1] 308284 0
04/07/2022
Approval date [1] 308284 0
08/12/2022
Ethics approval number [1] 308284 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 110178 0
Mrs Joanne Beer
Address 110178 0
Diet and Nutrition Department, Sir Charles Gairdner Hospital, Nedlands, WA 6009
Country 110178 0
Australia
Phone 110178 0
+61 403938747
Fax 110178 0
Email 110178 0
joanne.beer@research.uwa.edu.au
Contact person for public queries
Name 110179 0
Joanne Beer
Address 110179 0
Diet and Nutrition Department, Sir Charles Gairdner Hospital, Nedlands, WA 6009
Country 110179 0
Australia
Phone 110179 0
+61 403938747
Fax 110179 0
Email 110179 0
joanne.beer@research.uwa.edu.au
Contact person for scientific queries
Name 110180 0
Joanne Beer
Address 110180 0
Diet and Nutrition Department, Sir Charles Gairdner Hospital, Nedlands, WA 6009
Country 110180 0
Australia
Phone 110180 0
+61 403938747
Fax 110180 0
Email 110180 0
joanne.beer@research.uwa.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers on case by case assessment

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified data only in published results

What types of analyses could be done with individual participant data?
• Meta analysis

When can requests for individual participant data be made (start and end dates)?
From:
Post publication

To:
no end date

Where can requests to access individual participant data be made, or data be obtained directly?
• Via Principle Investigator at joanne.beer@research.uwa.edu.au

Are there extra considerations when requesting access to individual participant data?
No


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.