Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.
Brief Summary: Background:

Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ transplant. Patients need to take their prescribed medications and attend their appointments with the doctor.

Based on previous studies in other European countries, the cost of non-compliance after organ transplantation in Sweden is \>SEK 35 million/year.

Patients who lose their graft both lose quality of life and have decreased expected survival; moreover, retransplantation may be hampered by new HLA antibodies.

Question:

The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed medication regimen in renal transplant patients.

Methods and materials:

All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given information about the study and will then be asked to participate. Participants will be randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included patients will be closely monitored for 1 year regarding intake of prescribed medications.

Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each occasion when the patient takes medications from the dispenser. It has a SIM card and text messaging capabilities.

Addoz Portal™ is a web-based application that makes it possible to monitor and analyse medication intake. Each event in the medication dispenser is registered in the portal, which communicates with the care provider/support person by text message, e-mail or telephone.

Significance of the study:

In the future it may be possible to improve compliance in transplant patients. In particular, patients will feel secure since they will receive confirmation through the portal that they are taking their medications safely and accurately.


Options:
A: Arm Label: With Med-O-Wheel™; Type: N/A; Interventions: N/A | Arm Label: With out Med-O-Wheel™; Type: N/A; Interventions: N/A
B: Arm Label: Group CBT; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive-behavioral adherence promotion program | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Care | Intervention Type: BEHAVIORAL; Name: Cognitive-behavioral adherence promotion program; Assigned to Arm(s): Group CBT | Intervention Type: BEHAVIORAL; Name: Standard Care; Assigned to Arm(s): Standard Care
C: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management program with monthly sessions | Arm Label: Control; Type: OTHER; Interventions: Behavioral: Usual Care, containing one session | Intervention Type: BEHAVIORAL; Name: Self-management program with monthly sessions; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Usual Care, containing one session; Assigned to Arm(s): Control
D: Arm Label: Standard of Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Pocket PATH hand-held device; Type: EXPERIMENTAL; Interventions: Behavioral: Pocket PATH (Personal Assistant for Tracking Health) | Intervention Type: BEHAVIORAL; Name: Pocket PATH (Personal Assistant for Tracking Health); Assigned to Arm(s): Pocket PATH hand-held device

Answer: A