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Trial registered on ANZCTR


Registration number
ACTRN12617000703303
Ethics application status
Approved
Date submitted
10/05/2017
Date registered
16/05/2017
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel bundled intervention (4D’s) to improve adherence with phosphate control in people receiving haemodialysis for end stage kidney disease.
Scientific title
Nurse-led teach back intervention to improve adherence with phosphate control in people receiving haemodialysis for end stage kidney disease.
Secondary ID [1] 290763 0
None
Universal Trial Number (UTN)
U1111-1196-1365
Trial acronym
‘Taking control of your phosphate ‘4Ds’.
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 301365 0
Condition category
Condition code
Renal and Urogenital 301118 301118 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was guided by the behavioural theory Social Cognitive Theory. It consists of six (30-45 minutes) individual face to face educational sessions with the aid of a PowerPoint presentation via a laptop, teach-back and a booklet. Four initial educational sessions are in weeks one, two, three, four; and two booster sessions in weeks eight and 12. Both the educational topics and the booklet was developed following a systematic review and in consultation with an expect peer panel review. The educational topics and the booklet covers information on i) dietary phosphate control, ii) phosphate binder medications to reduce intestinal phosphate absorption, and iii) haemodialysis prescription to promote removal of phosphate. The teach-back method is used as a teaching method to ensure understanding of information provided during the educational session. Participants will also be encouraged to use the booklet during teach-back and at home to guide their self-management goals. An experience haemodialysis nurse will deliver the intervention to participants during their haemodialysis treatment times.
Intervention code [1] 297922 0
Lifestyle
Comparator / control treatment
The standard procedure at all three locations involves, an elevated serum phosphate level (>1.6mmol/L) triggering additional general phosphate control education (provided by nurses), review of phosphate binder medications and potentially the dose and/or type of binder altered by either medical practitioner (nephrologist or registrar) or nurse practitioner, and referral to the renal pharmacist. The role of the pharmacist is to provide education on the amended and/or new phosphate binder prescription (e.g. how, when, dose and side effects). If on the following monthly blood review, the same patient continues to have an elevated serum phosphate level >1.6mmol/L, a referral to the renal dietitian occurs. The dietitian provides general education on diet and drinks high in phosphate to avoid, and low phosphate diet and drinks to consume more frequently. At the end of the study participants in the control group will receive the booklet from the Principal researcher.
Control group
Active

Outcomes
Primary outcome [1] 301919 0
Primary outcome
Serum phosphate levels obtained from clinical laboratory results
Timepoint [1] 301919 0
Time point 1= Baseline
Repeated measurement: Time point 2 = week 4, Time point 3 = week 8, Time point 4 = week 12 (intervention conclusion)
Secondary outcome [1] 334600 0
General knowledge on phosphate control methods measured with a 20 item self-report instrument adapted from Ford, Pope, Hunt, & Gerald, 2004. The instrument has been validated in the study population.
Timepoint [1] 334600 0
Time point 1: Baseline
Repeated measurement: - Time point 3: week 12 (intervention conclusion)
Secondary outcome [2] 334601 0
Level of adherence to diet and drinks measured with a seven item self-report instrument adapted from Karavetian & Ghaddar, 2013. The instrument has been validated in the study population.
Timepoint [2] 334601 0
Time point 1= Baseline
Repeated measurement: Time point 3: week 12 (intervention conclusion)
Secondary outcome [3] 334602 0
Level of adherence to drugs (phosphate binder medication) measured with a eight item self-report instrument adapted from Morisky, Ang, Krousel-Wood, & Ward, 2008. The instrument has been validated in the study population.
Timepoint [3] 334602 0
Time point 1= Baseline
Repeated measurement: Time point 3: week 12 (intervention conclusion)
Secondary outcome [4] 334701 0
Levels of adherence to haemodialysis attendance (skipping and shortening behaviours) measured with a nine item self-report instrument adapted from Kim, Evangelista, Phillips, Pavlish, & Kopple, 2010 and information from electronic medical records. The instrument has been validated in the study population.
Timepoint [4] 334701 0
Time point 1= Baseline
Repeated measurement: Time point 3: week 12 (intervention conclusion)
Secondary outcome [5] 334702 0
Self-efficacy for managing chronic disease measured with a six item self-report instrument adapted from Lorig, et al., 2001. The instrument has been validated in the study population.
Timepoint [5] 334702 0
Time point 1= Baseline
Repeated measurement: Time point 3: week 12 (intervention conclusion)
Secondary outcome [6] 334875 0
Serum corrected calcium levels obtained from clinical laboratory results
Timepoint [6] 334875 0
Time point 1= Baseline
Repeated measurement: Time point 2 = week 4, Time point 3 = week 8, Time point 4 = week 12 (intervention conclusion)
Secondary outcome [7] 334876 0
Serum haemoglobin levels obtained from clinical laboratory results.
Timepoint [7] 334876 0
Time point 1= Baseline
Repeated measurement: Time point 2 = week 4, Time point 3 = week 8, Time point 4 = week 12 (intervention conclusion)
Secondary outcome [8] 334878 0
Serum potassium levels obtained from clinical laboratory results
Timepoint [8] 334878 0
Time point 1= Baseline
Repeated measurement: Time point 2 = week 4, Time point 3 = week 8, Time point 4 = week 12 (intervention conclusion)
Secondary outcome [9] 334879 0
Serum albumin levels obtained from clinical laboratory results
Timepoint [9] 334879 0
Time point 1= Baseline
Repeated measurement: Time point 2 = week 4, Time point 3 = week 8, Time point 4 = week 12 (intervention conclusion)

Eligibility
Key inclusion criteria
Age (18 years and over)
End stage kidney disease undergoing in-centre haemodialysis (three times per week) for at least three months
Able to speak English language
Elevated average serum phosphate levels of >1.6mmol/L for the previous three months before the study
Willing to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Malnourished (as protein intake takes precedence over phosphate control)
Receiving or under going home haemodialysis
Diagnosed with functional psychosis or organic brain disorder
Living in a nursing home as it is difficult for them to self-manage
Receiving palliative treatment

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 done by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation was based on figures derived from a previous study that used serum phosphate level as a physiological index of adherence to dietary phosphate and phosphate binder medication (Shi, et al., 2013). The sample size was calculated assuming 80% power (1-beta= 0.8), a type 1 error rate (alpha) of 5% (two-tailed) and an effect size of 0.5 (Standard Deviation = 0.39 mmol/L). Based on these parameters, using the online calculator
http:/biostat.mc.vanderbilt.edu/wiki/Main/PowerSampleSize version 3.1.2, 2014, a sample size of 21 participants per group is needed.
However, the sample size was inflated by a design effect of 0.03 which assumes a moderate intra-cluster correlation and an approximate cluster size of 21 participants. The calculation was further inflated by 20% to compensate for attrition and also by a further 15% to account for the possibility of non – normality of data forcing for non-parametric statistics. It was estimated a total sample of 60 participants per group (total=120) would be required to detect a meaningful difference of 0.39 mmol/L in serum phosphate level between groups. Three clusters are in each group; therefore 60 participants in the control group will mean that there are 20 participants per haemodialysis unit per shift.
Data analysis conducted on intention-to-treat basis. Measurements with only one measure - mean and Standard deviations utilising unpaired t-test if normal distribution. If non-parametric then Mann-Whitney test performed.
For repeated measures - paired t test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2017
Actual
4/09/2017
Date of last participant enrolment
Anticipated
1/11/2017
Actual
20/12/2017
Date of last data collection
Anticipated
1/02/2018
Actual
13/03/2018
Sample size
Target
120
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7983 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 7984 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [3] 7987 0
North Lakes Day Hospital - North Lakes
Recruitment postcode(s) [1] 15958 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 15960 0
4020 - Redcliffe
Recruitment postcode(s) [3] 15964 0
4509 - North Lakes

Funding & Sponsors
Funding source category [1] 296311 0
Hospital
Name [1] 296311 0
Royal Brisbane and Women’s Hospital Research Foundation
Country [1] 296311 0
Australia
Funding source category [2] 296401 0
Government body
Name [2] 296401 0
Queensland Health
Country [2] 296401 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Nursing
Queensland University of Technology
Kelvin Grove,
QLD 4059
Country
Australia
Secondary sponsor category [1] 295237 0
None
Name [1] 295237 0
Address [1] 295237 0
Country [1] 295237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297540 0
Royal Brisbane &Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 297540 0
Ethics committee country [1] 297540 0
Australia
Date submitted for ethics approval [1] 297540 0
29/05/2017
Approval date [1] 297540 0
12/06/2017
Ethics approval number [1] 297540 0
Ethics committee name [2] 297641 0
UHREC - Queensland University of Technology
Ethics committee address [2] 297641 0
Ethics committee country [2] 297641 0
Australia
Date submitted for ethics approval [2] 297641 0
22/05/2017
Approval date [2] 297641 0
Ethics approval number [2] 297641 0
1700000671

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

Contacts
Principal investigator
Name 71218 0
Mrs Molly Milazi
Address 71218 0
School of Nursing, Queensland University of Technology
N Block,
Victoria Park Rd
Kelvin Grove
Queensland 4059
Country 71218 0
Australia
Phone 71218 0
+61-4010209084
Fax 71218 0
Email 71218 0
molly.milazi@hdr.qut.edu.au
Contact person for public queries
Name 71219 0
Molly Milazi
Address 71219 0
School of Nursing, Queensland University of Technology
N Block,
Victoria Park Rd
Kelvin Grove
Queensland 4059
Country 71219 0
Australia
Phone 71219 0
+61-4010209084
Fax 71219 0
Email 71219 0
molly.milazi@hdr.qut.edu.au
Contact person for scientific queries
Name 71220 0
Molly Milazi
Address 71220 0
School of Nursing, Queensland University of Technology
N Block,
Victoria Park Rd
Kelvin Grove
Queensland 4059
Country 71220 0
Australia
Phone 71220 0
+61-4010209084
Fax 71220 0
Email 71220 0
molly.milazi@hdr.qut.edu.au

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


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.