Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox

Pilloxa25 enrolled

Overview

Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients. It is well established that lack of adherence to immunosuppressive medication drastically increases the risk of rejection reactions, graft loss and deaths. Pilloxa is a device meant to help users manage medication and support adherence to medication. This study evaluates if Pilloxa improves adherence to treatment for transplanted patient compared with conventional management. Patients who have received a transplanted kidney or liver will be studied. Pilloxa is a system comprising of: a box with 14 separate containers to temporarily store tablets/capsules in and that can be open by 14 independent lids, a smartphone application and cloud based servers. The pillbox will at given times detect if pills are present in the different compartments and can connect, send and receive information to/from mobile application and the cloud.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Kidney Transplant; Complications Liver Transplant; Complications

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patient had an organ (liver or kidney) transplanted. * Patient who wishes to participate in the study and who is able to understand, read, write and give written informed consent in the Swedish or English language. For persons under the age of 18, the guardians must understand, read, write and give written informed consent in the Swedish or English language. * Ongoing daily immunosuppressive medication that is expected to continue during the study period. * Handles medication by herself or, in the case of children, that medication is handled by the guardian. * The patients doses of immunosuppressants fits into the chambers of the product. * The patient's medicine ordination is not expected to change more often than once weekly. * Owns and uses a compatible smartphone, option for underage children that guardians hold a compatible smartphone. Exclusion Criteria: * Suffers from dementia, neurological disease or other cognitive impairment which causes problems in understanding instructions or managing medication independently. * Physical inability to use the product as intended.

Outcomes

Primary Outcomes

Adherence to medication

The proportion of days with adherence to medication for each patient. Adherence is defined as taking drugs within the interval within 120.0 minutes before to 120.0 minutes after each prescribed dose.

Time frame: During 6 months

Secondary Outcomes

Organ rejection

The incidence of biopsy verified acute and chronic rejections between the intervention and control groups will be studied.

Time frame: During 6 months

Concentration of Tacrolimus

The patients trough levels of tacrolimus will be compared between the groups. Optimal trough target zone is defined according to the recommended levels. Standard deviation of the variations of trough levels in each patient will also be compared between the groups.