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Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens
Author(s) -
De Geest Sabina,
SchäferKeller Petra,
Denhaerynck Kris,
Thannberger Nicole,
Köfer Susanne,
Bock Andreas,
Surber Christian,
Steiger Jürg
Publication year - 2006
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/j.1399-0012.2006.00493.x
Subject(s) - medicine , randomized controlled trial , transplantation , context (archaeology) , regimen , clinical trial , statistical significance , physical therapy , paleontology , biology
Background: Although non‐adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non‐adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational–behavioural intervention to increase adherence in non‐adherent RTx patients. We also assessed how NAH evolves over time. Methods: Eighteen RTx non‐adherent patients (age: 45.6±1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n=6) or an enhanced usual care group (EUCG) (n=12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine‐month period (three months intervention, six months follow‐up). Results: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG χ 2 =3.97, df=1, p=0.04; EUCG χ 2 =3.40, df=1, p=0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, χ 2 =1.05, df=1, p=0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six‐month follow‐up (i.e. at nine months). Conclusion: Our findings suggest an inclusion effect . Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.