Development and evaluation of an intervention to regain autonomy among patients undergoing dialysis

Dialysis is an invasive treatment for patients with end stage renal disease
which interferes their daily lives. A frequently mentioned complaint is loss of
autonomy. Central to the concept of autonomy is the extent to which patients
perceive control over their own lives. These so called perceptions of control
are essential to well-being and quality of life. Research shows that patients
treated with dialysis indeed report clinically lowered perceptions of control.
After transplantation, which is the preferred treatment for end stage renal
disease and which is generally associated with an increase in quality of life,
perceptions of control increase only limited. Similarly, general interventions
aimed at improving quality life or reducing psychological complaints do not
result in an increase in perceptions of control. Therefore, there is a need for
specific psychological interventions that focus on regaining perceptions of
control and hence, regaining autonomy during dialysis.

The primary objective of the studie is to develop an intervention specifically
aiming at regaining perceptions of control during dialysis and to examine its
efficacy.
Secondary aims are (a) to gain insight into mechanisms underlying its efficacy
(mediators) and (b) to gain insight into moderators of efficacy (i.e. for whom
and under which circumstances is the intervention efficacious).

The study applies a unblinded randomized controlled trial (RCT) design.
Patients who show clinically lowered levels of perceptions of control are
eligible for the intervention. In order to identify them, patients will fill in
a brief screening inventory to measure perceptions of control every three
months. In case they qualify, they will be randomly assigned to either the
intervention condition or the wait list control condition. In the latter
condition, patients will receive the intervention after a waiting period of
four to five months. One pre-intervention assessment and three follow-up
assessments will be administered, the last one six months after the end of the
intervention.

The intervention will be developed during the study based on an existing
intervention that is currently applied in the UMCG, the so called STERK
intervention. The STERK intervention is specifically developed for patients
with severe kidney disease, aiming at enhancing a healthy lifestyle and
improving quality of life. The intervention will be adapted for the current
study, focusing on setting attainable life goals by the patients. There will be
four sessions of 60 minutes each. The intervention will be offered in addition
to care as usual.

The burden imposed by the study to the patients consists of (a) filling in a
brief screening inventory (5 minutes to fill in) to measure perceptions of
control every three months, during the study period (2.5 years, 8 assessments);
in case they will receive the treatment: filling in questionnaires at four
assessment points, 30 minutes each, and 4 treatment sessions of one hour in the
dialysis center. For patients undergoing dialysis, fatigue is a potential side
effect. In order to lower the burden as much as possible for fatigued patients,
they will be offered the opportunity to fill in questionnaires during dialysis
and timing of the sessions will be decided based on preferences of the
individual patient.
When the intervention turns out to be successful, this can be considered as an
advantage to the patients receiving the intervention. No negative effects or
health risks are known regarding the STERK intervention (which forms the basis
for the current intervention) or regarding the therapeutic techniques that will
be applied, including cognitive-behavioral techniques.