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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03848585
• Other study ID #: 0001
• Status: Terminated
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: October 12, 2020

Study information

• Verified date: September 2021
• Source: Pilloxa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant; Complications
• Liver Transplant; Complications

Intervention

Device:
• Pilloxa Pillbox
A Pilloxa Pillbox is used for the prescribed immunosuppressants.

Other:
• Non active Pilloxa Pillbox
A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants.

Locations

Country	Name	City	State
Sweden	Patient Area Transplantation, Karolinska University Hospital	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Pilloxa

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Organ rejection	The incidence of biopsy verified acute and chronic rejections between the intervention and control groups will be studied.	During 6 months
Secondary	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
Secondary	Graft Function - Creatinine	Study the Creatinine (both kidney and liver) levels between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - eGFR	Study the Estimated glomerular filtration rate (eGFR, kidney transplantation) between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - Bilirubin	Study the Bilirubin levels between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - ALAT	Study the Alanine aminotransferase (ALAT) levels between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - ASAT	Study the Aspartate aminotransferase (ASAT) levels between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - INR	Study the International normalized ratio (INR) between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - Gamma-GT	Study the Gamma-glutamyl transferase (Gamma-GT) levels between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft Function - ALP	Study the Alkaline phosphatase (ALP, liver transplantation) levels between the intervention and control group.	Clinical routine sampling during 6 months
Secondary	Graft survival and patient survival	Definition of graft loss: Liver: Re-transplantation or death Kidney: Patient back on dialysis or death.	During 6 months
Secondary	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
Secondary	Serious Adverse Events and Adverse Events		During 6 months
Secondary	User-friendliness	The user-friendliness of the pillbox will be compared between the groups with surveys designed by Pilloxa.	At 6 months