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).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- Mean systolic blood pressure (SBP).
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Self-monitoring/Self-titration
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.
Intervention: Self-monitoring/Self-titration (Other)
Routine care
Patients in this arm will receive routine care for high blood pressure in the primary health care center.
Outcomes
Primary Outcomes
Mean systolic blood pressure (SBP).
Time Frame: 12 months from start of intervention
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
Secondary Outcomes
- Mean systolic blood pressure at 6 and 24 months(6 and 24 months)
- Mean diastolic blood pressure (DBP) at 6 and 24 months(6 and 24 months)
- EuroQoL-5D score(6,12,24 months)
- Percentage of patients with normal SBP and DBP(6,12, 24 months)
- Medication persistence(12 months)
- Medication adherence(12 months)
- Therapeutic inertia(6,12,24 months)
Investigators
José Sanfelix
Primary Care Physician
Fundación para la Investigación del Hospital Clínico de Valencia