Improvement of Medicine Adherence and the Following Positive Effects on Transplants in Patients After Organ Transplantation With Pilloxa's Electronic Pillbox
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Transplant; Complications
- Sponsor
- Pilloxa
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Adherence to medication
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Time Frame: 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 Outcomes
- Organ rejection(During 6 months)
- Graft Function - Bilirubin(Clinical routine sampling during 6 months)
- Graft Function - ALP(Clinical routine sampling during 6 months)
- Serious Adverse Events and Adverse Events(During 6 months)
- Graft Function - Gamma-GT(Clinical routine sampling during 6 months)
- Graft survival and patient survival(During 6 months)
- Concentration of Tacrolimus(Clinical routine sampling during 6 months)
- Graft Function - Creatinine(Clinical routine sampling during 6 months)
- Graft Function - eGFR(Clinical routine sampling during 6 months)
- Graft Function - ASAT(Clinical routine sampling during 6 months)
- Quality of Life(At 6 months compared to baseline)
- User-friendliness(At 6 months)
- Graft Function - ALAT(Clinical routine sampling during 6 months)
- Graft Function - INR(Clinical routine sampling during 6 months)