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Slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilloxa Pillbox | Experimental |
| |
| Non active Pilloxa Pillbox | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilloxa Pillbox | Device | A Pilloxa Pillbox is used for the prescribed immunosuppressants. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Söderdahl, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patient Area Transplantation, Karolinska University Hospital | Huddinge | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094829 | Derived | 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. |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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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.
| Non active Pilloxa Pillbox | Other | A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants. |
|
| 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 |