Study Stopped
Slow recruitment
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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2018
CompletedFirst Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedSeptember 23, 2021
September 1, 2021
1.9 years
February 15, 2019
September 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Organ rejection
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 - Bilirubin
Clinical routine sampling during 6 months
- +9 more secondary outcomes
Study Arms (2)
Pilloxa Pillbox
EXPERIMENTALNon active Pilloxa Pillbox
SHAM COMPARATORInterventions
A Pilloxa Pillbox is used for the prescribed immunosuppressants.
A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pilloxalead
Study Sites (1)
Patient Area Transplantation, Karolinska University Hospital
Huddinge, Sweden
Related Publications (1)
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.
PMID: 36094829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunnar Söderdahl, MD, PhD
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 21, 2019
Study Start
November 29, 2018
Primary Completion
October 12, 2020
Study Completion
October 12, 2020
Last Updated
September 23, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share