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Efficacy of a medication adherence enhancing intervention in transplantation: The maestro-tx trial

Dobbels, Fabienne, PhD ; De Bleser, Leentje, RN, PhD ; Berben, Lut, RN, PhD ; Kristanto, Paulus, PhD ; Dupont, Lieven, MD, PhD ; Nevens, Frederik, MD, PhD ; Vanhaecke, Johan, MD, PhD ; Verleden, Geert, MD, PhD ; De Geest, Sabina, RN, PhD

The Journal of heart and lung transplantation, 2017-05, Vol.36 (5), p.499-508 [Periódico revisado por pares]

United States: Elsevier Inc

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Título:
Efficacy of a medication adherence enhancing intervention in transplantation: The maestro-tx trial
Autor: Dobbels, Fabienne, PhD ; De Bleser, Leentje, RN, PhD ; Berben, Lut, RN, PhD ; Kristanto, Paulus, PhD ; Dupont, Lieven, MD, PhD ; Nevens, Frederik, MD, PhD ; Vanhaecke, Johan, MD, PhD ; Verleden, Geert, MD, PhD ; De Geest, Sabina, RN, PhD
Assuntos: Adult ; Aged ; Belgium ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Graft Survival ; heart transplantation ; Heart Transplantation - adverse effects ; Heart Transplantation - methods ; Heart Transplantation - mortality ; Humans ; Immunosuppressive Agents - administration & dosage ; Kaplan-Meier Estimate ; liver transplantation ; Liver Transplantation - adverse effects ; Liver Transplantation - methods ; Liver Transplantation - mortality ; lung transplantation ; Lung Transplantation - adverse effects ; Lung Transplantation - methods ; Lung Transplantation - mortality ; Male ; medication adherence ; Medication Adherence - statistics & numerical data ; Middle Aged ; Postoperative Care - methods ; randomized controlled trial ; Risk Assessment ; Surgery ; Survival Rate ; Tacrolimus - administration & dosage ; Time Factors ; Transplantation Immunology - drug effects ; Treatment Outcome ; Young Adult
É parte de: The Journal of heart and lung transplantation, 2017-05, Vol.36 (5), p.499-508
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SourceType-Scholarly Journals-1
ObjectType-News-1
ObjectType-Feature-3
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Descrição: Background Well-designed RCTs testing the efficacy of adherence-enhancing interventions on post-transplant medication adherence and clinical outcomes remain scarce. Methods This RCT enrolled adult heart, liver and lung transplant patients who were > 1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3 months run-in period, patients were randomized 1:1 to the intervention or control group (visit 2), followed by a 6 months intervention (visit 2-4) and a 6 months adherence follow-up period (visit 5). All patients used electronic monitoring (EM) for 15 months for adherence measurement, generating a daily binary adherence score per patient. Five years clinical event-free survival (mortality or re-transplantation) post-intervention was evaluated. The intervention group (IG) received staged multicomponent tailored behavioral interventions (visit 2-4) building on the social cognitive theory and trans-theoretical model (e.g. EM feedback, motivational interviewing). Control group patients (CG) received usual care and attended visits 1-5 only. Intention-to-treat analysis used generalized estimating equation modeling and Kaplan Meier survival analysis. Results Out of 247 patients consenting, 205 were randomized (103 IG; 102 CG). At baseline, the average daily proportions of patients with correct dosing (82.6% IG; 78.4% CG) and timing adherence (75.8% IG; 72.2% CG) were comparable. The IG had a 16% higher dosing adherence post-intervention (95.1% IG; 79.1% CG; p< 0.001), resulting in the odds of adherence to be 5 times higher in the IG than in the CG (OR=5.17; 95% CI= 2.86-9.38). This effect sustained at end of follow-up (similar results for timing adherence). Five years clinical event-free survival was 82.5% in the IG versus 72.5% in the CG (p= 0.18). Conclusion Our intervention was efficacious in improving adherence and sustainable. Further research should investigate its clinical impact, cost-effectiveness, and scalability.
Editor: United States: Elsevier Inc
Idioma: Inglês

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Efficacy of a medication adherence enhancing intervention in transplantation: The maestro-tx trial

Dobbels, Fabienne, PhD ; De Bleser, Leentje, RN, PhD ; Berben, Lut, RN, PhD ; Kristanto, Paulus, PhD ; Dupont, Lieven, MD, PhD ; Nevens, Frederik, MD, PhD ; Vanhaecke, Johan, MD, PhD ; Verleden, Geert, MD, PhD ; De Geest, Sabina, RN, PhD

United States: Elsevier Inc

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