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Trial registered on ANZCTR


Registration number
ACTRN12613000564752
Ethics application status
Approved
Date submitted
4/05/2013
Date registered
17/05/2013
Date last updated
20/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pharmacist medicine counselling on treatment goals in renal dialysis patients
Scientific title
In outpatients receiving renal dialysis, is standard care plus medicine counselling by a pharmacist more effective than standard care alone in improving phosphate levels?
Secondary ID [1] 282445 0
RD012030 (Waiakto District Health Board, New Zealand)
Universal Trial Number (UTN)
U1111-1139-2551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 289055 0
Condition category
Condition code
Renal and Urogenital 289395 289395 0 0
Kidney disease
Public Health 289505 289505 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fortnightly medication counselling and education by a qualified pharmacist who has been trained to work with renal dialysis patients.

Each session will consist of approximately 45 minutes and will focus on a particular topic (medicines for calcium regulation, blood pressure control et cetera). Each session is administered on a one-on-one basis.

Each patient will receive 12 counselling sessions. Patients will receive self-assessment tools and memory aids to use during the sessions and take home afterwards. Patients will also receive Waikato Dialysis Unit standard of care.
Intervention code [1] 287089 0
Behaviour
Comparator / control treatment
Waikato Dialysis Unit standard of care. This will include a monthly results/chart review and 3 monthly clinic assessment including with dietician input
Control group
Active

Outcomes
Primary outcome [1] 289503 0
Serum phospate levels in millimoles per litre (mmol/L). This is measured via serum assay (phosphate level) monthly.
Timepoint [1] 289503 0
Six months and twelve months
Secondary outcome [1] 302628 0
The number of patients who achieve end dialysis target body weight.

Target body weight is determined by the renal doctors. It is the lowest weight a patient can reach in the presence of a normal blood pressure and no signs of fluid build up.
Nurses normally record the weight of the patient before and after dialysis and compare it to the target weight. Referrals will be made to the doctor for a review of target weight and dialysis regimen if a patient regularly fails to meet target body weight after dialysis.
Timepoint [1] 302628 0
Six months and twelve months
Secondary outcome [2] 302629 0
Ultrafiltration volume (litres).

Each patient has a target weight determined by the doctors. Nurses take a pre-dialysis weight and then compare it to the target weight to determine how much fluid the patient gained in-between dialysis. The difference between the pre-dialysis weight and the target weight determines the Ultrafiltration volume (the amount of fluid that will be remove during the dialysis).
Timepoint [2] 302629 0
Six months and twelve months
Secondary outcome [3] 302630 0
Haemoglobulin level in millimoles per litre (mmol/L).

This is measured by a full blood count test monthly.
Timepoint [3] 302630 0
Six months and twelve months
Secondary outcome [4] 302631 0
Calcium level in millimoles per litre (mmol/L).

This is measured via serum assay (calcium level) monthly.
Timepoint [4] 302631 0
Six months and twelve months
Secondary outcome [5] 302632 0
Parathyroid hormone levels in picomoles/litre (pmol/L).

This is measured via serum assay (parathyroid hormone level, 2nd generation assay) three monthly.
Timepoint [5] 302632 0
Six months and twelve months
Secondary outcome [6] 302633 0
Blood pressure in millimeters of mercury (mm hg).

This is measured via automatic sphygmomanometer to check the patients blood pressure. BP checked before dialysis, every hour during dialysis, and post dialysis.
Timepoint [6] 302633 0
Six months and twelve months
Secondary outcome [7] 302634 0
Days of hospitalisation (in days).

This is measured through medical records, with assistance of audit office/clinical coding.
Timepoint [7] 302634 0
Six months and twelve months

Eligibility
Key inclusion criteria
Patients with end stage renal disease who recieve dialysis as outpatients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Inability to consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cohort study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis is by intention-to-treat (patients are analysed in the cohort they are initially assigned to, even if they subsequently choose to leave the study).

Each cohort is compared with itself (at baseline (average results over a 3 month lead in period) and at the end of the evaluation period).

Each cohort is also compared against the other (at baseline and at the end of the evaluation period).

Analysis will include:

1. Summary statistics (mean and standard deviation, or median and percentiles, depending on whether the data are normally distributed or not).
2. Hypothesis significance test (0.05 and 0.01 level).
3. Parameter estimates (95% and 99% confidence intervals, if the distribution of the data allows this).

The sample size was calculated pragmatically, based on the maxium number of patients we had pharmacist time funded to provide counselling for. This determined the size of the intervention group, and the same size was used for the control group. No power calculations were performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/05/2013
Actual
Date of last participant enrolment
Anticipated
25/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 5064 0
New Zealand
State/province [1] 5064 0
Waikato

Funding & Sponsors
Funding source category [1] 287223 0
Self funded/Unfunded
Name [1] 287223 0
This study in not funded at all.
Country [1] 287223 0
Primary sponsor type
Hospital
Name
Waikato District Health Board
Address
Renal Dialysis Unit
Waikato District Health Board
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 285976 0
None
Name [1] 285976 0
Address [1] 285976 0
Country [1] 285976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289210 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 289210 0
Ethics committee country [1] 289210 0
New Zealand
Date submitted for ethics approval [1] 289210 0
15/02/2013
Approval date [1] 289210 0
11/04/2013
Ethics approval number [1] 289210 0
13/NTB/22

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

Contacts
Principal investigator
Name 39790 0
Dr Peter Sizeland
Address 39790 0
Renal Services
Waiakto District Health Board
Private Bag 3200
Hamiliton 3240
Country 39790 0
New Zealand
Phone 39790 0
+647 8398899
Fax 39790 0
+647 8388657
Email 39790 0
peter.sizeland@waikatodhb.health.nz
Contact person for public queries
Name 39791 0
Rajan Ragupathy
Address 39791 0
Pharmacy Services
Waikato District Health Board
Private Bag 3200
Hamilton 3240
Country 39791 0
New Zealand
Phone 39791 0
+647 8398899
Fax 39791 0
+647 8398769
Email 39791 0
rajan.ragupathy@waikatodhb.health.nz
Contact person for scientific queries
Name 39792 0
Rajan Ragupathy
Address 39792 0
Pharmacy Services
Waikato District Health Board
Private Bag 3200
Hamilton 3240
Country 39792 0
New Zealand
Phone 39792 0
+647 8398899
Fax 39792 0
+647 8398769
Email 39792 0
rajan.ragupathy@waikatodhb.health.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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