Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000608662
Ethics application status
Approved
Date submitted
3/06/2014
Date registered
6/06/2014
Date last updated
31/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving medicine adherence in kidney transplantation
Scientific title
In adults more than one month post-kidney transplantation, is a multi-factorial intervention including medicine review, DVD and health coaching more effective than usual care in improving immunosuppressant medicine adherence?
Secondary ID [1] 284743 0
Nil known
Universal Trial Number (UTN)
U1111-1157-5996
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage kidney disease requiring kidney transplantation 292066 0
Condition category
Condition code
Renal and Urogenital 292404 292404 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants in the intervention group will receive a once only, one hour home visit comprising a home medicine review and a ten minute DVD to motivate people to take their medicines.
Fortnightly ten minute telephone health coaching for three months will be conducted.
Intervention code [1] 289499 0
Behaviour
Comparator / control treatment
Ongoing medical care provided to a patient who has received a kidney transplant attending routine outpatient clinic follow up and primary care
Control group
Active

Outcomes
Primary outcome [1] 292265 0
7% improvement in immunosuppressant medicine adherence compared to ‘usual care’ in kidney transplantation measured by the Medication Event Monitoring System, laboratory tests, prescription refill and self-report.
Timepoint [1] 292265 0
Outcomes will be assessed at baseline, 3, 6 and 9 months.
Secondary outcome [1] 308591 0
Medicine adherence will be set at equal to or >80% for all other medicines assessed by prescription refill, laboratory tests, and self-report.
Timepoint [1] 308591 0
Outcomes will be assessed at baseline, 3, 6 and 9 months.

Eligibility
Key inclusion criteria
Comprehend English, and prescribed immunosuppressant medicines in kidney transplantation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults living in supported accommodation (medicines are managed by staff)

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)
Participants will be recruited by the PhD student and Research Fellow at kidney transplant outpatient clinics with the assistance of the renal transplant coordinators and nephrologists at the five sites. People who express interest in participating in the study will be visited in their homes for informed consent and enrolment by the Research Fellow. Each patient will be given a code number which will be given to the off-site statistician for treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Centralised, stratified randomisation of participants based upon the site (5 sites involved)
Off-site statistician prepares an excel file containing a sheet for each of the five sites containing the randomisation list and unique randomisation number and treatment allocation in sequential order
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Intention-to-treat. Descriptive statistics will be used to compare baseline characteristics. Categorical data will be presented as frequencies and percentages. Normally distributed data will be presented as means and standard deviations and non-symmetrical data as medians and inter-quartile ranges. The primary analysis will be based on the follow-up data by assessing the difference in adherence based on the MEMS score using a linear mixed-effects model. This model will accommodate for the unequal variances in repeated measurements while adjusting for random effects of participant. Secondary analyses, including medication adherence measured using surrogate and self-reported measures of medication adherence will be analysed using linear mixed-effects model for continuous variables and generalized estimated equation for binomial outcomes.

To estimate the sample size we wish to detect an increase of 7% in the MEMS score in the intervention group, allowing for a standard deviation of 9% in each group. Assuming a two-tailed hypothesis test with significance level of 5% and a power of 80%, we estimate at least 27 patients are required in each group. Taking into consideration an attrition rate of 20%, the number required is 32 per group, making a total sample of 64 participants. Our preliminary work with our partner investigators have suggested that attrition is likely to be higher based on their experience with this group of patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2014
Actual
22/09/2014
Date of last participant enrolment
Anticipated
9/10/2015
Actual
13/10/2015
Date of last data collection
Anticipated
30/11/2016
Actual
13/01/2017
Sample size
Target
64
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2531 0
The Alfred - Prahran
Recruitment hospital [2] 2532 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 2533 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 2534 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 2535 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 289331 0
Government body
Name [1] 289331 0
National Health & Medical Research Council Partnership project
APP1056717
Country [1] 289331 0
Australia
Funding source category [2] 289332 0
University
Name [2] 289332 0
Monash University
Country [2] 289332 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Nursing Academy
Monash University School of Nursing and Midwifery
Clayton Campus
Building 13D Level 3,
Wellington Rd
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 288019 0
None
Name [1] 288019 0
Address [1] 288019 0
Country [1] 288019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291100 0
Monash Health HREC B
Ethics committee address [1] 291100 0
Ethics committee country [1] 291100 0
Australia
Date submitted for ethics approval [1] 291100 0
Approval date [1] 291100 0
04/07/2013
Ethics approval number [1] 291100 0
HREC/13/SHB/10
Ethics committee name [2] 291101 0
Monash Health Research Governance
Ethics committee address [2] 291101 0
Ethics committee country [2] 291101 0
Australia
Date submitted for ethics approval [2] 291101 0
Approval date [2] 291101 0
23/07/2013
Ethics approval number [2] 291101 0
HREC/13/SHB/10 (local reference number: 13176B)
Ethics committee name [3] 291102 0
Austin Health Research Governance
Ethics committee address [3] 291102 0
Ethics committee country [3] 291102 0
Australia
Date submitted for ethics approval [3] 291102 0
Approval date [3] 291102 0
23/10/2013
Ethics approval number [3] 291102 0
HREC/13/SHB/10 (local reference number: SSA/13/Austin/83)
Ethics committee name [4] 291103 0
Melbourne Health Research Governance
Ethics committee address [4] 291103 0
Ethics committee country [4] 291103 0
Australia
Date submitted for ethics approval [4] 291103 0
Approval date [4] 291103 0
25/09/2013
Ethics approval number [4] 291103 0
HREC/13/SHB/10 (local reference number: 2013.142)
Ethics committee name [5] 291104 0
Alfred Health Research Governance
Ethics committee address [5] 291104 0
Ethics committee country [5] 291104 0
Australia
Date submitted for ethics approval [5] 291104 0
Approval date [5] 291104 0
29/11/2013
Ethics approval number [5] 291104 0
HREC/13/SHB/10
Ethics committee name [6] 291105 0
St. Vincent's Hospital (Melbourne) Research Goverenance
Ethics committee address [6] 291105 0
Ethics committee country [6] 291105 0
Australia
Date submitted for ethics approval [6] 291105 0
Approval date [6] 291105 0
07/01/2014
Ethics approval number [6] 291105 0
HREC/13/SHB/10 (local reference number: HREC-D094/13)
Ethics committee name [7] 291109 0
Monash University HREC
Ethics committee address [7] 291109 0
Ethics committee country [7] 291109 0
Australia
Date submitted for ethics approval [7] 291109 0
Approval date [7] 291109 0
20/08/2013
Ethics approval number [7] 291109 0
CF13/2440-2013001269

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

Contacts
Principal investigator
Name 48878 0
A/Prof Allison Fiona Williams
Address 48878 0
Monash Nursing Academy
Monash University School of Nursing and Midwifery
Clayton Campus
Building 13D Level 3,
Wellington Rd
Clayton VIC 3800
Country 48878 0
Australia
Phone 48878 0
+ 61 3 9904 4377
Fax 48878 0
+ 61 3 9905 4837
Email 48878 0
[email protected]
Contact person for public queries
Name 48879 0
Allison Fiona Williams
Address 48879 0
Monash Nursing Academy
Monash University School of Nursing and Midwifery
Clayton Campus
Building 13D Level 3,
Wellington Rd
Clayton VIC 3800
Country 48879 0
Australia
Phone 48879 0
+ 61 3 9904 4377
Fax 48879 0
+ 61 3 9905 4837
Email 48879 0
[email protected]
Contact person for scientific queries
Name 48880 0
Allison Fiona Williams
Address 48880 0
Monash Nursing Academy
Monash University School of Nursing and Midwifery
Clayton Campus
Building 13D Level 3,
Wellington Rd
Clayton VIC 3800
Country 48880 0
Australia
Phone 48880 0
+ 61 3 9904 4377
Fax 48880 0
+ 61 3 9905 4837
Email 48880 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNephrologists' management of patient medications in kidney transplantation: Results of an online survey.2015https://dx.doi.org/10.1111/jep.12394
N.B. These documents automatically identified may not have been verified by the study sponsor.