Kidney Transplant; Complications, Liver Transplant; Complications
Conditions
Keywords
Immunosuppressants, Treatment adherence
Brief summary
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.
Interventions
DEVICEPilloxa Pillbox
A Pilloxa Pillbox is used for the prescribed immunosuppressants.
OTHERNon active Pilloxa Pillbox
A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants.
Sponsors
Pilloxa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The analysis is blinded. The statistician will not have access to the affiliation of the users until the statistical analysis of the study data is finalised.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to medication | During 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Tacrolimus | Clinical routine sampling during 6 months | 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. |
| Graft Function - Creatinine | Clinical routine sampling during 6 months | Study the Creatinine (both kidney and liver) levels between the intervention and control group. |
| Graft Function - eGFR | Clinical routine sampling during 6 months | Study the Estimated glomerular filtration rate (eGFR, kidney transplantation) between the intervention and control group. |
| Graft Function - Bilirubin | Clinical routine sampling during 6 months | Study the Bilirubin levels between the intervention and control group. |
| Graft Function - ALAT | Clinical routine sampling during 6 months | Study the Alanine aminotransferase (ALAT) levels between the intervention and control group. |
| Graft Function - ASAT | Clinical routine sampling during 6 months | Study the Aspartate aminotransferase (ASAT) levels between the intervention and control group. |
| Organ rejection | During 6 months | The incidence of biopsy verified acute and chronic rejections between the intervention and control groups will be studied. |
| Graft Function - Gamma-GT | Clinical routine sampling during 6 months | Study the Gamma-glutamyl transferase (Gamma-GT) levels between the intervention and control group. |
| Graft Function - ALP | Clinical routine sampling during 6 months | Study the Alkaline phosphatase (ALP, liver transplantation) levels between the intervention and control group. |
| Graft survival and patient survival | During 6 months | Definition of graft loss: Liver: Re-transplantation or death Kidney: Patient back on dialysis or death. |
| Quality of Life | At 6 months compared to baseline | 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. |
| Serious Adverse Events and Adverse Events | During 6 months | — |
| User-friendliness | At 6 months | The user-friendliness of the pillbox will be compared between the groups with surveys designed by Pilloxa. |
| Graft Function - INR | Clinical routine sampling during 6 months | Study the International normalized ratio (INR) between the intervention and control group. |
Countries
Sweden
Outcome results
None listed