Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Randomized Trial Investigating the Influence of Pharmaceutical Care on the Intraindividual Variability of Tacrolimus Concentrations Early After Kidney Transplant.
Brief Summary: Primary end-point

The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. Coefficients of variation were calculated from the average of dose-corrected tacrolimus blood concentration(CV= Standard Deviation (SD) x 100/mean) of study visits day 10, 14, 21, 30, 60 and 90 post kidney transplant.

Secondary end-points

1. Secondary outcomes included evaluate percentage of patients who achieved target levels of tacrolimus in day study visits 7, 10, 14, 21, 28, 60 e 90 days after kidney transplant;
2. Tacrolimus bioavailability profile during the period of 3 months,characterized by mean and standard deviation (SD) of dose corrected tacrolimus blood concentration(ng/ml/mg);
3. Assess patient adherence through validated questionnaire "Portuguese version of Basel Scale Adherence Rating Immunosuppressive Drugs (BAASIS) scale". It consists of a four-item questionnaire measuring nonadherence to immunosuppressives over the past four weeks. This questionnaire assesses omission of single doses or successive doses, timing deviations \>2h and dose reductions. Responses are given on a six-point scale: never, once per month, every second week, every week, more than once per week and every day. Patients that answer different from "never" in any of the four questions are considered as nonadherent;
4. We evaluated renal function eGFR by Modification of Diet in Renal Disease (MDRD);
5. We evaluated Incidence of Infections;
6. We evaluated Treated acute rejection episodes;
7. We evaluated Death cases;
8. We evaluated Graft loss cases;
9. We evaluated Discontinuation of immunosuppressive treatment;
10. We evaluated Hospital readmissions.

Study Design

This was a single-center, prospective, randomized and controlled study to evaluate the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after transplantation. The authors designed the protocol, acquired and maintained the data, and conducted the statistical analysis. The protocol was approved by an independent ethics committee. All subjects signed a written informed consent before enrollment and the study was conducted according to good clinical practices and declaration of Helsinki. This study was conducted at Hospital do Rim between February 2014 and December 2014, 128 randomized and were followed for 3 months after transplantation.


Options:
A: Arm Label: Multi-component Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Action-focused problem-solving, Device: Electronic pillbox monitoring, dose reminders, and feedback | Arm Label: Attention control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Action-focused problem-solving; Assigned to Arm(s): Multi-component Intervention | Intervention Type: DEVICE; Name: Electronic pillbox monitoring, dose reminders, and feedback; Assigned to Arm(s): Multi-component Intervention
B: Arm Label: 1 with pharmaceutical intervention; Type: EXPERIMENTAL; Interventions: Other: Pharmaceutical Intervention | Arm Label: 2 without pharmaceutical intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Pharmaceutical Intervention; Assigned to Arm(s): 1 with pharmaceutical intervention
C: Arm Label: Tacrolimus twice-daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tacrolimus twice daily | Arm Label: Envarsus XR; Type: ACTIVE_COMPARATOR; Interventions: Drug: Envarsus XR | Intervention Type: DRUG; Name: Envarsus XR; Assigned to Arm(s): Envarsus XR | Intervention Type: DRUG; Name: Tacrolimus twice daily; Assigned to Arm(s): Tacrolimus twice-daily
D: Arm Label: Pharmaceutical care programme supported by mHealth; Type: EXPERIMENTAL; Interventions: Other: Multidisciplinary follow-up programme supported by mHealth | Arm Label: Routine healthcare by the transplant team; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Multidisciplinary follow-up programme supported by mHealth; Assigned to Arm(s): Pharmaceutical care programme supported by mHealth

Answer: B