NCT03242785

Impact of Self-monitoring of Blood Pressure and Self-titration of Medication in the Control of Hypertension (ADAMPA)

Impact of Self-monitoring of Blood Pressure and Self-titration of Antihypertensive Medication in the Control of Hypertension and Adherence to Treatment. A Pragmatic, Randomized, Controlled Clinical Trial (ADAMPA Study).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Hypertension
• Adjustment
• Adherence, Medication

Interventions

Type	Name	Description
OTHER	Self-monitoring/Self-titration	The intervention of the ADAMPA trial is not pharmacological but an intervention that modifies usual clinical practice. The intervention of self-monitoring and self-titration of the medication is composed of 3 elements: 1. Education of the patient: information and training on hypertension, its risks, management, the benefits of an adequate control and the generic measures for an optimal control. 2. Training for self-monitoring: Patients will be trained to perform the self-measurement of blood pressure correctly (and recording their values in the sheet enabled for this purpose) 3. Training for self-titration: patients will be instructed on the target BP numbers, individualized for each patient, on the mode of action against specific figures, including self-adjustment of drug treatment.

Timeline

• Start date: 2017-07-21
• Primary completion: 2019-07-01
• Completion: 2020-08-25
• First posted: 2017-08-08
• Last updated: 2021-08-19

Locations

1 site across 1 country: Spain