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

Study Overview
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Brief Summary
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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.

Official Title
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Improvement of Medicine Adherence and the Following Positive Effects on Transplants in Patients After Organ Transplantation With Pilloxa's Electronic Pillbox

Conditions
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Kidney Transplant; Complications, Liver Transplant; Complications

Intervention / Treatment
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* Device: Pilloxa Pillbox
* Other: Non active Pilloxa Pillbox


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilloxa Pillbox<br> | Device: Pilloxa Pillbox<br>* A Pilloxa Pillbox is used for the prescribed immunosuppressants.<br>|
| Sham Comparator: Non active Pilloxa Pillbox<br> | Other: Non active Pilloxa Pillbox<br>* A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ rejection | The incidence of biopsy verified acute and chronic rejections between the intervention and control groups will be studied. | 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. | Clinical routine sampling during 6 months | 
| Graft Function - Creatinine | Study the Creatinine (both kidney and liver) levels between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - eGFR | Study the Estimated glomerular filtration rate (eGFR, kidney transplantation) between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - Bilirubin | Study the Bilirubin levels between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - ALAT | Study the Alanine aminotransferase (ALAT) levels between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - ASAT | Study the Aspartate aminotransferase (ASAT) levels between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - INR | Study the International normalized ratio (INR) between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - Gamma-GT | Study the Gamma-glutamyl transferase (Gamma-GT) levels between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft Function - ALP | Study the Alkaline phosphatase (ALP, liver transplantation) levels between the intervention and control group. | Clinical routine sampling during 6 months | 
| Graft survival and patient survival | Definition of graft loss: Liver: Re-transplantation or death Kidney: Patient back on dialysis or death. | During 6 months | 
| Quality of Life | The numbers of acute re-admissions for intervention will be studied and compared between the groups. Changes in scoring generated using Rand-36 evaluation of medical outcomes pre and after the study period will be evaluated between the groups. | At 6 months compared to baseline | 
| Serious Adverse Events and Adverse Events |  | During 6 months | 
| User-friendliness | The user-friendliness of the pillbox will be compared between the groups with surveys designed by Pilloxa. | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunosuppressants, Treatment adherence