Skip to main content
OpenTrials
Completed

NCT Number: NCT03242785

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Adherence, Medication Adjustment Behavior Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Salud Valencia Clínico Malvarrosa

Valencia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-monitoring/Self-titration

Other

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:

  • 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.
  • 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)
  • 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.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. EuroQoL-5D score

    Time frame: 6,12,24 months

    Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up

  5. 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.

  6. 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).

  7. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Satisfaction with the intervention

    Time frame: 12 months

    Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Carlos III Health Institute
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

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).

Acronym: ADAMPA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 8, 2017
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.