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

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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Transplant; Complications; Kidney Transplant; Complications
• Intervention / Treatment: Device: Pilloxa Pillbox; Other: Non active Pilloxa Pillbox

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden
    • Patient Area Transplantation, Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pilloxa
• Investigators: Principal Investigator: Gunnar Söderdahl, MD, PhD, Karolinska University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): October 12, 2020
• Study Completion (Actual): October 12, 2020

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Treatment adherence; Immunosuppressants
• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No