Rationale and design of a pragmatic clinical trial to assess the

Bmc Fam Pract · Sep 2018

Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol.

Lack of control of hypertension is one of the most prevalent problems encountered by general practitioners (GPs). Self-measured blood pressure monitoring at home (SMBP) and self-titration of medication could be a good strategy to improve hypertension management, however, evidence is limited and not conclusive. We aimed to assess the effectiveness, in the primary care setting, of an intervention that includes educational components, SMBP and self-titration of antihypertensive medication to decrease systolic blood pressure compared to usual care, in a population with poorly controlled hypertension, during a 12-month period. ⋯ If the data from this trial show positive results, the study may contribute to a change of strategy in the treatment of hypertension, focusing on the patient as the main actor to achieve blood pressure control. Furthermore, this approach might contribute to the financial sustainability of the National Health Service.

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- José Sanfélix-Genovés, Clara L Rodríguez-Bernal, Irene Marco-Moreno, Patricia Martinez-Ibañez, Lucía Martinez-Ibañez, María Bóveda-García, Ignacio Barreira-Franch, Mercedes Calleja-Del Ser, Greta Borrás-Moreno, Eugenia Avelino-Hidalgo, Marina Escrig-Veses, Margherita Lauriano, Margarita Giménez-Loreiro, Laura Bellot-Pujalte, Aníbal García-Sempere, Salvador Peiró, Gabriel Sanfélix-Gimeno, and ADAMPA group.
- Centro de Salud de Nazaret, Departamento de Salud de Valencia Clínic-La Malvarrosa, Valencia, Spain. sanfelix_jos@gva.es.
- Bmc Fam Pract. 2018 Sep 24; 19 (1): 160160.
BackgroundLack of control of hypertension is one of the most prevalent problems encountered by general practitioners (GPs). Self-measured blood pressure monitoring at home (SMBP) and self-titration of medication could be a good strategy to improve hypertension management, however, evidence is limited and not conclusive. We aimed to assess the effectiveness, in the primary care setting, of an intervention that includes educational components, SMBP and self-titration of antihypertensive medication to decrease systolic blood pressure compared to usual care, in a population with poorly controlled hypertension, during a 12-month period.MethodsPragmatic, controlled, randomized, unblinded clinical trial with two parallel groups assigned in a ratio of 1:1 to self-management (which includes educational components, SBMP and self-titration of antihypertensive medication based on a patient's GP's pre-established adjustment plan) or to usual care (with educational components too).DiscussionIf the data from this trial show positive results, the study may contribute to a change of strategy in the treatment of hypertension, focusing on the patient as the main actor to achieve blood pressure control. Furthermore, this approach might contribute to the financial sustainability of the National Health Service.Trial RegistrationThis trial has been registered in the database with reference number EudraCT: 2016-003986-25. Registered 05 May 2017, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-003986-25.

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Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol.

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