Kidney Transplant; ComplicationsNCT03848585
Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox
A study testing Pilloxa Pillbox and Non active Pilloxa Pillbox in people with Kidney Transplant; Complications and Liver Transplant; Complications, run by Pilloxa at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant; Complications, Liver Transplant; Complications
- What is being tested?
- Pilloxa Pillbox and Non active Pilloxa Pillbox
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 29 Nov 2018to 12 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Patient Area Transplantation, Karolinska University Hospital
Huddinge
About this study
Official title: 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.
- Being tested
- Pilloxa Pillbox, Non active Pilloxa Pillbox
- Keywords
- Immunosuppressants, Treatment adherence
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilloxa PillboxDevice
A Pilloxa Pillbox is used for the prescribed immunosuppressants.
Non active Pilloxa PillboxOther
A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants.
| Study group | Role | What they receive |
|---|---|---|
| Pilloxa Pillbox | Experimental | Not described Receives: Device: Pilloxa Pillbox |
| Non active Pilloxa Pillbox | Sham comparator | Not described Receives: Other: Non active Pilloxa Pillbox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 6 months
Secondary outcomes (14)
Organ rejection
The incidence of biopsy verified acute and chronic rejections between the intervention and control groups will be studied.
Measured: 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.
Measured: Clinical routine sampling during 6 months
Graft Function - Creatinine
Study the Creatinine (both kidney and liver) levels between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - eGFR
Study the Estimated glomerular filtration rate (eGFR, kidney transplantation) between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - Bilirubin
Study the Bilirubin levels between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - ALAT
Study the Alanine aminotransferase (ALAT) levels between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - ASAT
Study the Aspartate aminotransferase (ASAT) levels between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - INR
Study the International normalized ratio (INR) between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - Gamma-GT
Study the Gamma-glutamyl transferase (Gamma-GT) levels between the intervention and control group.
Measured: Clinical routine sampling during 6 months
Graft Function - ALP
Study the Alkaline phosphatase (ALP, liver transplantation) levels between the intervention and control group.
Measured: 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.
Measured: 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.
Measured: At 6 months compared to baseline
Serious Adverse Events and Adverse Events
Measured: During 6 months
User-friendliness
The user-friendliness of the pillbox will be compared between the groups with surveys designed by Pilloxa.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start29 Nov 2018
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pilloxa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Söderdahl, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848585
- Sponsor's protocol ID
- 0001
- Status last verified
- Sep 2021
- First submitted
- 15 Feb 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Medicine Adherence and the Following Positive Effects on Transplants in Patients After Organ Transplantation With Pilloxa's Electronic Pillbox
- ClinicalTrials.gov ID
- NCT03848585
- Acronym / sponsor ID
- 0001
- Keywords
- Immunosuppressants, Treatment adherence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PilloxaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilloxa Pillbox | Experimental | Device: Pilloxa Pillbox |
| Non active Pilloxa Pillbox | Sham comparator | Other: Non active Pilloxa Pillbox |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilloxa PillboxA Pilloxa Pillbox is used for the prescribed immunosuppressants. | Device | Pilloxa Pillbox |
| Non active Pilloxa PillboxA Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants. | Other | Non active Pilloxa Pillbox |
Primary outcome
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.
14 secondary outcomes
Organ rejection
Time frame: During 6 months
Concentration of Tacrolimus
Time frame: Clinical routine sampling during 6 months
Graft Function - Creatinine
Time frame: Clinical routine sampling during 6 months
Graft Function - eGFR
Time frame: Clinical routine sampling during 6 months
Graft Function - Bilirubin
Time frame: Clinical routine sampling during 6 months
Graft Function - ALAT
Time frame: Clinical routine sampling during 6 months
Graft Function - ASAT
Time frame: Clinical routine sampling during 6 months
Graft Function - INR
Time frame: Clinical routine sampling during 6 months
Graft Function - Gamma-GT
Time frame: Clinical routine sampling during 6 months
Graft Function - ALP
Time frame: Clinical routine sampling during 6 months
Graft survival and patient survival
Time frame: During 6 months
Quality of Life
Time frame: At 6 months compared to baseline
Serious Adverse Events and Adverse Events
Time frame: During 6 months
User-friendliness
Time frame: At 6 months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 36094829Mellon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Söderdahl, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilloxa Pillbox and Non active Pilloxa Pillbox in people with Kidney Transplant; Complications and Liver Transplant; Complications, run by Pilloxa at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to medication (time frame: During 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.