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 chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(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, chi(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.
RCT Entities:
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 chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(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, chi(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.
Authors: Cynthia L Russell; Donna Hathaway; Laura M Remy; Dana Aholt; Debra Clark; Courtney Miller; Catherine Ashbaugh; Mark Wakefield; Sangbeak Ye; Vincent S Staggs; Rebecca J Ellis; Kathy Goggin Journal: Am J Transplant Date: 2019-08-20 Impact factor: 8.086
Authors: Nikolaos Pagonas; Kourosh Yusefi; Felix S Seibert; Frederic Bauer; Konstantinos Markakis; Benjamin Sasko; Walter Zidek; Theresa Götze; Peter Schlattmann; Richard Viebahn; Nina Babel; Timm H Westhoff Journal: J Nephrol Date: 2018-11-15 Impact factor: 3.902
Authors: Cynthia L Russell; Catherine Ashbaugh; Leanne Peace; Muammer Cetingok; Karen Q Hamburger; Sarah Owens; Deanna Coffey; Andrew W Webb; Donna Hathaway; Rebecca P Winsett; Richard Madsen; Mark R Wakefield Journal: Clin Transplant Date: 2013 Sep-Oct Impact factor: 2.863
Authors: Cynthia L Russell; Sarah Owens; Karen Q Hamburger; Denise A Thompson; Rebecca R Leach; Muammer Cetingok; Donna Hathaway; Vicki S Conn; Catherine Ashbaugh; Leanne Peace; Richard Madsen; Rebecca P Winsett; Mark R Wakefield Journal: J Gerontol Nurs Date: 2009-10-09 Impact factor: 1.254
Authors: Jia-Rong Wu; Debra K Moser; Marla J De Jong; Mary Kay Rayens; Misook L Chung; Barbara Riegel; Terry A Lennie Journal: Am Heart J Date: 2008-12-24 Impact factor: 4.749