Clinical trial NCT03848585: Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox
Official title: Improvement of Medicine Adherence and the Following Positive Effects on Transplants in Patients After Organ Transplantation With Pilloxa's Electronic Pillbox
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Transplant; Complications
Liver Transplant; Complications
Keywords: Immunosuppressants
Treatment adherence
Lead sponsor: Pilloxa
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Adherence to medication
timeFrame: During 6 months
Secondary outcomes:
measure: Organ rejection
timeFrame: During 6 months
measure: Concentration of Tacrolimus
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - Creatinine
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - eGFR
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - Bilirubin
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - ALAT
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - ASAT
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - INR
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - Gamma-GT
timeFrame: Clinical routine sampling during 6 months
measure: Graft Function - ALP
timeFrame: Clinical routine sampling during 6 months
measure: Graft survival and patient survival
timeFrame: During 6 months
measure: Quality of Life
timeFrame: At 6 months compared to baseline
measure: Serious Adverse Events and Adverse Events
timeFrame: During 6 months
measure: User-friendliness
timeFrame: At 6 months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Patient Area Transplantation, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Gunnar Söderdahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.