promoting Medication AdheRence and Self-management among kidney transplant recipients: a randomized controlled trial (the MARS Trial)

Nonadherence to the lifelong medication and lifestyle recommendations after
transplantation has been identified as a major cause of acute and chronic
rejection, mortality and decreased quality of life. However, studies have shown
the prevalence of nonadherence to be relatively high among all age groups (30%
- 65%). Among other chronic diseases, interventions promoting adherence and
self-management appear to be effective in influencing aforementioned
consequences of nonadherence. Ellis et al. showed that a multisystemic
intervention among diabetes, asthma and HIV patients was effective in promoting
medication adherence. Effective interventions for promoting adherence and
self-management among kidney transplant recipients are however scarce and the
urgent need for these interventions has been highlighted in a number of
systematic reviews.

In this project we aim to anticipate the need for effective interventions and
develop an outreaching systemic intervention for promoting adherence and
self-management among adolescent and adult kidney transplant recipients aged
from 12 years. The effectiveness of the intervention will be tested in a
Randomized Controlled Trial (RCT). Consecutively, we aim to develop a manual
and training module in order to facilitate implementation of the intervention.

A RCT will be conducted to assess the effectiveness of the intervention. Data
will be collected at baseline (T0), after a run-in period of 35 days necessary
for patients to get adjusted to the electronic monitoring (T1), at the end of
the intervention (T2) and after a 6 month follow-up (T3). The data collection
of participants in the control group will be at similar time points.

During the RCT participants will be assigned to the experimental condition
(intervention group) or the control group.
Intervention group: Patients assigned to the intervention group will receive an
outreaching, systemic, adherence promoting intervention in addition to the
treatment as usual. The social network of the patient will be involved in the
intervention. The patient and an important other of the patient will complete
baseline and follow-up measures.
Control group: Patients assigned to the control group will receive treatment as
usual, which consists of consultations with the nephrologist and nurse
practitioner, and upon indication with the social worker. Non-adherence issues
are addressed during these consultations in the outpatient clinic on
indication. Patients in the control group will complete the same baseline and
follow-up measures as participants in the intervention group .

Participating in the current study does not add a high medical or psychological
risk. On the contrary, it is believed that the patient will benefit from the
intervention. Since only non-adherent patients are eligible for inclusion,
these patients also run a high risk of serious consequences due to the problems
associated with non-adherence to the medical regimen. The intervention aims to
improve adherence and selfmanagement, which decreases the occurrence of
consequences. Furthermore, when psychological risks are noticed, psychological
strategies to anticipate these risks are carried out. When risks are beyond to
the scope of the intervention, patients will be referred to a professional.

The time spent participating in the intervention can be experienced as a
burden. However, given the seriousness of the problem and the possibility to
intervene with this intervention this burden is justified. Involving the social
network may be demanding but it is hypothesized that results will be more
sustainable when empowering both the patient and the network.
Furthermore, several measures are taken to minimize the burden for the
patients. Firstly, the intervention is outreaching and can take place on a
location the patient prefers, for example at home which safes the patient some
time. Secondly, the intervention is tailored to the needs of the patient and
the social network. Therefore, we are not restricted to unnecessary yet
protocolized steps predetermined in an intervention protocol. Duration and
frequency of appointments are also adjusted to the preferences of the patient
and social network. Moreover, patients can refuse participation or withdraw at
any time.

The burden of the use of an electronic monitoring device can be considered as
very little since it only requires for the patient to push a button. The
dosette box which the device can be adjusted is already used by the majority of
the patients, but can also be used with other ways of storing medication.
Therefore, using the device does not require an adaptation to the medication
routine apart from pushing the button.