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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Hypertension; Adherence, Medication; Adjustment

Treatments: Other: Self-monitoring/Self-titration

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03242785

ADAMPA

2016-003986-25 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 366 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 2 patient groups

Self-monitoring/Self-titration

Experimental group

Description:

The intervention consists of self-monitoring blood pressure at home, and subsequent medication self-titration, based on a medication adjustment plan pre-established by the family physician, in patients with uncontrolled hypertension.

Treatment:

Other: Self-monitoring/Self-titration

Routine care

No Intervention group

Description:

Patients in this arm will receive routine care for high blood pressure in the primary health care center.