Effects of Self-monitoring on Outcome of Chronic Kidney Disease

In the Netherlands an estimated 750.000 patients suffer from CKD, with a kidney
function of less than 60%, and it can be expected that this number will
increase significantly in the forthcoming decades. A typical characteristic of
this patient population is the high level of co-morbidity: Hypertension is the
most frequent complication of CKD. For CKD-patients blood pressure control is
not only vital for decreasing cardiovascular risk; but also for the decrease of
proteinuria in the urine. It is possible that all of this slows down
progression of CKD and subsequently reliance on renal replacement therapy may
be postponed. Unfortunately, adequate blood pressure control seems hard to
achieve. CKD patients generally have two treatment options to control their
blood pressure: pharmacological treatment and reducing salt intake.
Regarding the salt-intake, this is hard to achieve due to salt *hidden* in
prepared meals and is not added by the patients themselves. In usual care, CKD
patients collect urine for 24 hours and return it to the laboratory. Usually,
they get the results days (or sometimes even months) later during their next
doctor*s appointment.
The current procedure to measure salt intake is inefficient and lacks immediate
feedback. Recently, innovative Lab-on-a-Chip technology is being developed that
is also applicable for self-monitoring of sodium levels in 24 hours urine.
Self-monitoring is a vital element of self-manage¬ment and the last couple of
years self-management is becoming increasingly important. Several studies have
shown that self-management increases treatment results and enhances
psychological well-being of patients. The interventions that are most effective
for long-term adherence are complex and combines self-monitoring with
information, psychological therapy, counseling and feedback. However, little is
known about self-management in patients with Chronic Kidney Disease.

The overall aim of the project is to improve health outcomes and autonomy of
CKD patients by testing a self-management care model regarding hypertension
control. Furthermore, this study will investigate the impeding and facilitating
factors for implementation of self-management and provide knowledge about the
attitude and wishes regarding self-management of the patients and health care
workers.

It is an open randomized controlled trial, in which 150 CKD patients in stage
III with hypertension are randomly assigned to either the control condition or
intervention condition. After the intervention two follow-up measurements (at 3
and 6 months after the start of the intervention groups) will take place.
In the preparation phase focusgroup interviews will be conducted with CKD
patients and health care workers for tine-tuning the intervention. We strive
for 4 focusgroups with approximately 8 CKD patients and 4 focusgroups with
approximately 8 health care workers.
Before including patients for the RCT, we will pilottest the intervention in 15
CKD patients.

The intervention group receives (besides the care as usual) a self-management
care model consisting of; self-monitoring sodium intake, keeping dietary
diaries, receiving feedback, two motivational interviews and, if necessary,
tailored self-management modules

There are no risks attached to the study and the participating CKD patients are
older than 18 years and mentally competent. The total extent of the study for
each individual participant will be 6 months.
The total burden for the control group will be: protocolled instruction for
bloodpressure and sodium intake, three times filling out a questionnaire and
once an additional visiting the hospital (including drawing blood) and three
times handing in 24 hours urine).
The total burden for the intervention group will be: protocolled instruction
for bloodpressure and sodium intake, three times filling out a questionnaire
and three times additional visiting the hospital (including drawing blood and
hand in 24 hours urine, and two motivational interview conversations),
collecting 24-hour urine, home measuring bloodpressure and sodium, filling in
nutrition diaries, tailored behavior modules if requested by the patient.