Transplant Trial Watch

A Prospective Randomized Trial on the Effect of Using an Electronic Monitoring Drug Dispensing Device to Improve Adherence and Compliance.

Henriksson J, Tyden G, et al.

Transplantation 2016 Jan;100(1):203-9


Aims
To study the influence of an electronic medication dispenser (EMD) on compliance and clinical outcomes in kidney transplant recipients compared to standard care.

Interventions
Participants were randomized to receive either an EMD, or current standard care.

Participants
80 renal transplant recipients

Outcomes
Primary outcomes measured were compliance, number of missed doses and missed follow-up visits. Secondary outcomes included emergency hospital admissions, rejection and P-creatine level.

Follow-up
1 year

CET Conclusions
Compliance and adherence to immunosuppressive drug therapy after renal transplantation is a major problem and markedly influences outcomes. The problem is particularly evident in the younger patient between 15 and 25 years of age. Thus this very interesting study has investigated in a randomised trial the effect of an electronic monitoring device (EMD) on both adherence and compliance. Compliance in the intervention group was 97.8% but compliance was not assessed in the control group. It was interesting that certain days of the week, namely Saturdays and Thursdays, were more likely to be associated with lack of compliance. Biopsy confirmed rejection was more common in controls than in the intervention group. Thus, this provided quite good evidence that an electronic monitoring device for immunosuppressive drug administration was associated with a high compliance and possibly with a lower rejection rate. This might be an important tool for use in younger patients.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
Clinicaltrials.gov NCT01709097

Funding source
Industry & non-industry funded