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

August 18, 2021 updated by: José Sanfelix, Fundación para la Investigación del Hospital Clínico de Valencia

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).

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Departamento de Salud Valencia Clínico Malvarrosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Routine care
Patients in this arm will receive routine care for high blood pressure in the primary health care center.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months from start of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean systolic blood pressure at 6 and 24 months
Time Frame: 6 and 24 months
Difference in mean systolic blood pressure, in mmHg at 6 and 24 months of follow-up between intervention and control groups determined at physicians' practice with a validated automatic electronic sphygmomanometer
6 and 24 months
Mean diastolic blood pressure (DBP) at 6 and 24 months
Time Frame: 6 and 24 months
Difference in mean diastolic blood pressure, in mmHg at 6 and 24 months of follow-up between intervention and control groups determined at physicians' practice with a validated automatic electronic sphygmomanometer
6 and 24 months
Percentage of patients with normal SBP and DBP
Time Frame: 6,12, 24 months
Percentage of patients with SBP<140 mmHg and DBP <90 mmHg at 6, 12 y 24 months of follow-up
6,12, 24 months
EuroQoL-5D score
Time Frame: 6,12,24 months
Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up
6,12,24 months
Medication adherence
Time Frame: 12 months
Proportion of days covered (PDC) will be measured, dividing the number of days with dispensed medication by the number of days of follow-up. Patients with PDC ≥ 80 will be considered adherent. In case of polypharmacy, patients with PDC ≥ 80 for all the medications will be considered adherent.
12 months
Medication persistence
Time Frame: 12 months
Persistence will be defined as the time of continuous utilization of the correspondent medication from the start of follow-up until its discontinuation (when the patient stops picking up the medication after a 60-days grace period, once the period with available medication from the previous dispensation is finished).
12 months
Therapeutic inertia
Time Frame: 6,12,24 months
Defined as the quotient resulting of dividing the number of patients whose pharmacological treatment has not been modified, by the number of patients with SBP and/or DBP measured in the physician's practice, with values above the recommendations of the European Society of Hypertension and European Society of Cardiology. This measurements will be performed at 6, 12 and 24 months.
6,12,24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in lifestyle
Time Frame: 6,12,24 months
Changes in lifestyle (smoking, exercise, body weight) at 6, 12, and 24 months compared to these characteristics at baseline.
6,12,24 months
Adverse events
Time Frame: 12 months
We will assess if any of the following adverse events are present during the follow-up: angor, myocardial infarction, stroke, hypotensive crisis and death.
12 months
Health services utilization
Time Frame: 6,12 and 24 months
Health services utilization during follow-up (6, 12 and 24 months), will include: visits to primary care nurse and physician, related to high blood pressure (HBP) (including telephone and home), emergency visits to hospital, hospital admissions, hospitalization days per admission and principal diagnosis.
6,12 and 24 months
Incremental cost per quality-adjusted life year gained
Time Frame: 12 months
Incremental cost per quality-adjusted life year gained in the intervention group as compared to the control group.
12 months
Satisfaction with the intervention
Time Frame: 12 months
Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carlos III Health Institute
Spanish Clinical Research Network - SCReN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabriel Sanfélix-Gimeno, Dr, Health Services Research Unit FISABIO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADAMPA
  • 2016-003986-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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