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Trial registered on ANZCTR


Registration number
ACTRN12613000791730
Ethics application status
Approved
Date submitted
14/07/2013
Date registered
16/07/2013
Date last updated
16/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing Progression of Chronic Kidney Disease in Primary Care: A Quality Improvement Pilot Study Using Specialist Renal Nursing in the Primary Care Setting
Scientific title
In adults with type 2 diabetes at high risk of chronic kidney disease progression, does a health service delivery model using a nurse-led clinic result in improved markers of chronic kidney disease progression, decreased risk of cardiovascular events, and improved self-management? A pilot study.
Secondary ID [1] 282815 0
Nil
Universal Trial Number (UTN)
U1111-1145-5901
Trial acronym
CKD Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 289591 0
Proteinuria 289592 0
Hypertension 289593 0
Diabetes 289594 0
Non-adherence 289596 0
Risk of cardiovascular events 289597 0
Condition category
Condition code
Renal and Urogenital 289928 289928 0 0
Kidney disease
Metabolic and Endocrine 289929 289929 0 0
Diabetes
Public Health 289930 289930 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves a series of sessions in GP practices led by a nephrology Nurse Practitioner with the assistance of a practice nurse, to deliver medical care based on best practice guidelines through tailored education and the development of individualised care plans, and using self-management and patient-centered theory utilizing the Flinders Chronic Care model. Participants will be seen fortnightly for 30 minutes for 12 weeks by the NP and the practice nurse in an intense induction phase, and then for 30 minutes monthly in a maintenance and monitoring phase to 12 months. A detailed patient education package was developed for the study and included information on diabetes and its complications, blood pressure management, lifestyle modifications, medication adherence, smoking cessation and dietary advice including low salt intake (dietary sodium intake less than 2.3 g/day). All patients were also given a booklet on self-management developed for the study where they could record all clinical results, self-care goals, individualised medication charts and other important information. Adherence to intervention will be monitored through self-reporting using self-management survey instruments, GP attendance records, and clinical and laboratory parameters. Outcomes will all be ascertained as 3 monthly repeated measures.
Intervention code [1] 287500 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289984 0
Proteinuria (urinary albumin to creatinine ratio, ACR)
Timepoint [1] 289984 0
12 months
Secondary outcome [1] 303704 0
Blood pressure (manual using JNC 7 protocol)
Timepoint [1] 303704 0
12 months
Secondary outcome [2] 303705 0
Glycosylated haemoglobin (HbA1c) by serum assay (Abbott)
Timepoint [2] 303705 0
12 months
Secondary outcome [3] 303706 0
Estimated glomerular filtration rate ('175' 4-variable MDRD equation)
Timepoint [3] 303706 0
12 months
Secondary outcome [4] 303707 0
5-year absolute cardiovascular risk (likelihood of a cardiovascular event over 5 years estimated using New Zealand prediction equations (the New Zealand Guidelines Group: New Zealand Cardiovascular Guidelines Handbook: A summary resource for primary care practitioners, 2 edn. Wellington: (New Zealand) Ministry of Health; 2009 )
Timepoint [4] 303707 0
12 months
Secondary outcome [5] 303708 0
Body mass index (BMI)
Timepoint [5] 303708 0
12 months
Secondary outcome [6] 303709 0
Serum cholesterol by assay (Abbott)
Timepoint [6] 303709 0
12 months
Secondary outcome [7] 303710 0
Prevalence of active smoking (Partners In Health instrument, self reported)
Timepoint [7] 303710 0
12 months
Secondary outcome [8] 303711 0
Overall medical knowledge (Partners In Health instrument, self reported)
Timepoint [8] 303711 0
12 months
Secondary outcome [9] 303712 0
Overall self management (Partners In Health instrument, self reported)
Timepoint [9] 303712 0
12 months
Secondary outcome [10] 303713 0
Adherence to medication (Partners In Health instrument, self reported)
Timepoint [10] 303713 0
12 months
Secondary outcome [11] 303714 0
Prescription of angiotensin converting enzyme inhibitors or receptor antagonists
Timepoint [11] 303714 0
12 months
Secondary outcome [12] 303715 0
Prescription of aspirin
Timepoint [12] 303715 0
12 months
Secondary outcome [13] 303716 0
Prescription of lipid lowering medication
Timepoint [13] 303716 0
12 months
Secondary outcome [14] 303717 0
Adoption of a health lifestyle (Partners In Health instrument)
Timepoint [14] 303717 0
12 months

Eligibility
Key inclusion criteria
1. Age >= 18 years
2. Diagnosis of type 2 diabetes mellitus
3. Diagnosis of hypertension
3. Proteinuria defined as an albumin to creatinine ratio (ACR) > 30
mg/mmol on at least three occasions separated by at least 1 week
4. At ‘high risk of CKD progression’ as defined by
a) at least 12 months of uncontrolled diabetes, defined as HbA1c consistently >8%, AND/OR
b) at least 12 months of uncontrolled hypertension, defined as BP consistently >140/90 mmHg, AND
c) a history of poor attendance and engagement with their GP (history of unplanned non-attendance of 25% or more of scheduled appointments over the course of 12 months).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. CKD due to renal parenchymal disease other than diabetic nephropathy
2. Unsuitable for the intervention in the view of their treating GP
3. Unwilling or unable to provide consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be screened and recruited through the clinical records of two primary care (General Practitioner) practices. All eligible patients will be identified, and initially given written information and invitation to participate by their GP or practice nurse. All will be subsequently re-contacted by phone to answer any questions, and offered an initial assessment. Since there is no control group, allocation procedures and concealment in not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary analysis of study data will use regression models. For continuous data, we will use linear models and for categorical ones we will use logistic models. To account for internal correlation between repeated patient observations, a random effect model will be used for each dependent variable that includes all data from all time periods simultaneously, with observations over time from the same participant sharing the same random effects, assuming different random effects for different participants. To account for non-response bias, regression coefficients will be estimated using the maximum likelihood method. Equivalent analyses after a normalising data transformation will be carried out if non-normality of outcomes is evinced. When a transformation is applied, location estimates and confidence intervals will be transformed back to the original scale, with first-degree bias correction.

The study is a pilot study, a pilot study, intended to be a small scale preliminary study in order to evaluate feasibility, time, cost, and effect size (statistical variability). As such, no specific calculation for sample size was performed. A minimum sample size of 50 participants was considered a pragmatic target.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5187 0
New Zealand
State/province [1] 5187 0
Hawke's Bay

Funding & Sponsors
Funding source category [1] 287596 0
Government body
Name [1] 287596 0
New Zealand Ministry of Health
Address [1] 287596 0
CVD diabetes Long Term Conditions
Personal Health Service Improvement
Sector Capability and Implementation
Ministry of Health
PO Box 5013
Wellington 6145
New Zealand
Country [1] 287596 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Ministry of Health
Address
CVD diabetes Long Term Conditions
Personal Health Service Improvement
Sector Capability and Implementation
Ministry of Health
PO Box 5013
Wellington 6145
Country
New Zealand
Secondary sponsor category [1] 286345 0
Hospital
Name [1] 286345 0
Hawke's Bay District Health Board
Address [1] 286345 0
Corner Omahu Road and McLeod Street
Private Bag 9014
Hastings 4156
New Zealand
Country [1] 286345 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289572 0
Hawke's Bay DHB Institutional Review Board
Ethics committee address [1] 289572 0
Hawke's Bay DHB
Corner Omahu Road and McLeod Street
Private Bag 9014
Hastings 4156
Ethics committee country [1] 289572 0
New Zealand
Date submitted for ethics approval [1] 289572 0
Approval date [1] 289572 0
30/04/2011
Ethics approval number [1] 289572 0
No approval ID, approved by IRB as "CKD Pilot"

Summary
Brief summary
Chronic kidney disease (CKD) is an important global health issue, the leading causes being diabetes mellitus and hypertension. Early detection and effective management of risk factors have the potential to delay CKD progression to end stage kidney disease (ESKD), and decrease mortality and morbidity from cardiovascular (CV) disease. We will evaluated a nurse-led intervention utilizing specialist renal nursing in the primary care setting to reduce accepted risk factors for CKD progression and CV disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41374 0
Ms Rachael Claire Walker
Address 41374 0
Nurse Practitioner,
C/- Renal House,
Hawke’s Bay Regional Hospital,
Hawke’s Bay District Health Board,
Private Bag 9014,
Hastings 4120,
Country 41374 0
New Zealand
Phone 41374 0
+64 27 234 9205
Fax 41374 0
Email 41374 0
Rachael.Walker@hawkesbaydhb.govt.nz
Contact person for public queries
Name 41375 0
Dr Nick Raymond Polaschek
Address 41375 0
Senior Project Manager,
CVD diabetes Long Term Conditions,
Personal Health Service Improvement,
Sector Capability and Implementation,
Ministry of Health,
PO Box 5013,
Wellington 6145,
Country 41375 0
New Zealand
Phone 41375 0
+64 27 234 9205
Fax 41375 0
Email 41375 0
Nick_Polaschek@moh.govt.nz
Contact person for scientific queries
Name 41376 0
A/Prof Mark Roger Marshall
Address 41376 0
Clinical Head, Department of Renal Medicine,
Counties Manukau District Health Board,
Private Bag 93311,
Otahuhu,
Auckland 1640,
Country 41376 0
New Zealand
Phone 41376 0
+64 21 461766
Fax 41376 0
Email 41376 0
mrmarsh@woosh.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary