impact of self-monitoring of blood pressure and self-titration of medication in the control of hypertension (adampa)

Conditions: Hypertension; Adjustment; Adherence, Medication

Summary: the adampa study is a pragmatic randomized clinical trial which aims to evaluate the effectiveness of an intervention based on self-monitoring and self-titration of medication in poorly controlled hypertensive patients 40 years and older. the total duration of the study is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary endpoint (difference in mean systolic blood pressure, in mmhg, between the intervention and control groups).

adampa study. objectives: to evaluate the comparative effectiveness of an intervention that includes educational components, self-monitoring of blood pressure and self-titration of antihypertensive medication in the improvement of control of hypertension compared to usual care in a poorly controlled population of hypertensive patients. design: pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms. disease related to the study: hypertension. main outcome measure: difference in mean systolic blood pressure, in mmhg. at 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer study population: patients assigned to the valencia clinic-la malvarrosa health department. total number of patients to be randomized: 458 (229 per arm). duration of intervention: 12 months (also, a pragmatic extension with passive follow-up is planned for 24 months, collecting a reduced set of outcome variables, as secondary variables) calendar and expected completion date: the trial will take place over 3 years (6 months of recruitment, 12 months of follow-up for the main analysis of results, 12 months of pragmatic follow-up at 24 months, and finally 6 months for reporting results). estimated completion date: 2020.

Eligibility criteria:
inclusion criteria: * 40 years or older * diagnosis of hypertension of any origin * systolic blood pressure (sbp) \> 145 or diastolic blood pressure (dbp) \> 90 mm hg at baseline * voluntarily participation in the study and having signed the corresponding informed consent. exclusion criteria: * inability to understand and/or perform self-adjustment of the medication, including dementia or significant cognitive impairment (at the discretion of the investigator performing the recruitment). * history of orthostatic hypotension (fall\> 20 mm hg in sbp after adopting the orthostatic position). * sbp\> 200 or dbp\> 100 mm hg on the baseline examination * being on treatment with more than 4 antihypertensive drugs * participation in another study on high blood pressure or in a clinical trial * presence of tremor or neurological disease that makes it difficult to perform bp self-measurement. * presence of arrhythmia * presence of terminal illness * chronic disability impeding to leave home * history of acute cardiovascular event in the last 3 months * hypertension managed directly by specialist physicians outside the primary care setting. * spouse selected for the study * non-resident or transient patients * pregnancy

Keywords: self-monitoring education self-titration antihypertensives