Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00231803 |
| Other study ID # |
HIC#04.154 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2005 |
| Est. completion date |
June 2008 |
Study information
| Verified date |
May 2022 |
| Source |
Memorial University of Newfoundland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Advanced kidney disease with it's associated heart and blood vessel problems are becoming
more frequent. These problems markedly affect length and quality of life and cost a lot to
treat. Treatments are known that can prevent development of advanced kidney and heart
disease. These treatments are not being optimally applied in the current health system. This
study aims to identify people with relatively early stage chronic kidney disease. With the
participation of these people, the study will test whether a nurse coordinated clinic
involving a medical kidney specialist, applying the known treatments, can reduce or delay the
onset of advanced kidney disease and heart and blood vessel problems such as heart attack,
stroke and death, to a greater extent than usual care. The study will also address issues of
costs associated with care and illness. The nature of the care provided by the health care
professionals will be studied to see how best to achieve good health outcomes.
Description:
The pilot study is designed in two phases. The first phase is intended to provide data on
some key points that need to be addressed prior to future funding applications to the CIHR
and the NHLBI. These applications are currently tentatively planned for the fall of 2005. The
second phase of the pilot study is intended to more completely establish the feasibility of
successfully completing the full trial by examining the issue of contamination and the
ability of the intervention to generate a difference between the groups with regard to use of
efficacious therapies and control of modifiable risk factors, or intermediate variables on
the causal pathway to the clinical end-points in the full-scale trial. The second phase will
also address the need to describe the operation of the experimental intervention more
thoroughly. Finally, the second phase of the pilot study will compare the randomized study
groups with regard to short-term quality-of-life outcomes.
Phase1
1. How long does it take to recruit 100 patients per study site?
2. What recruitment strategies are most efficient?
3. How do the baseline characteristics of those recruited compare to referred populations,
and to the general population with CKD?
4. How do the nephrologist and nurse work together to provide care to those in the
intervention group?
5. What is the nature of the care provided by the nurses and physicians to those in the
intervention group?
6. Is the study nurse able to manage the patient load?
7. How much time and resources are needed to a) provide care, b) to carry out study
measurements?
8. Can health care resources used be measured for economic analysis?
Phase II
1. What is the rate of loss to follow-up?
2. What is the overall estimate of the primary outcome event rate?
3. By one year of follow-up, what is the difference between the study groups in terms of:
1. Protocol interventions used (estimates contamination)
2. Proportion i) smoking; and proportion achieving ii) BP, iii) lipid, iv) diabetes,
v) anemia, vi) acidosis, vii) mineral metabolism targets
3. Quality of Life
4. Satisfaction with care Randomized, parallel, two group, multicentre, clinical trial
of people with CKD, with or without diabetes mellitus or proteinuria. The intention
is to roll the pilot study into the full-scale trial if the pilot itself is deemed
successful. A laboratory-based case finding method will be used preferentially to
identify potential participants. This will be supplemented by practice-based
case-finding approaches where necessary to ensure recruitment of a representative
population. Randomization will be by a central computer-based telephone process.
Stratification will be by center and presence of diabetes and proteinuria. The
intervention consists of a protocol guided, multiple risk factor and chronic
disease care model-like approach delivered by a trained nurse supported by a
nephrologist and will be based in a nephrology clinic like setting.
