<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03242785</url>
  </required_header>
  <id_info>
    <org_study_id>ADAMPA</org_study_id>
    <secondary_id>2016-003986-25</secondary_id>
    <nct_id>NCT03242785</nct_id>
  </id_info>
  <brief_title>Impact of Self-monitoring of Blood Pressure and Self-titration of Medication in the Control of Hypertension (ADAMPA)</brief_title>
  <acronym>ADAMPA</acronym>
  <official_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).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Clinical Research Network - SCReN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carlos III Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the&#xD;
      effectiveness of an intervention based on self-monitoring and self-titration of medication in&#xD;
      poorly controlled hypertensive patients 40 years and older. The total duration of the study&#xD;
      is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary&#xD;
      endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and&#xD;
      control groups).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ADAMPA study. Objectives: To evaluate the comparative effectiveness of an intervention that&#xD;
      includes educational components, self-monitoring of blood pressure and self-titration of&#xD;
      antihypertensive medication in the improvement of control of hypertension compared to usual&#xD;
      care in a poorly controlled population of hypertensive patients.&#xD;
&#xD;
      Design: Pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms.&#xD;
&#xD;
      Disease related to the study: Hypertension.&#xD;
&#xD;
      Main outcome measure: Difference in mean systolic blood pressure, in mmHg. At 12 months of&#xD;
      follow-up between the intervention and control groups, determined at physicians' practice&#xD;
      with a validated automatic electronic sphygmomanometer&#xD;
&#xD;
      Study population: Patients assigned to the Valencia Clinic-La Malvarrosa Health Department.&#xD;
      Total number of patients to be randomized: 458 (229 per arm).&#xD;
&#xD;
      Duration of intervention: 12 months (also, a pragmatic extension with passive follow-up is&#xD;
      planned for 24 months, collecting a reduced set of outcome variables, as secondary variables)&#xD;
&#xD;
      Calendar and expected completion date: The trial will take place over 3 years (6 months of&#xD;
      recruitment, 12 months of follow-up for the main analysis of results, 12 months of pragmatic&#xD;
      follow-up at 24 months, and finally 6 months for reporting results). Estimated Completion&#xD;
      Date: 2020.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2017</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean systolic blood pressure (SBP).</measure>
    <time_frame>12 months from start of intervention</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean systolic blood pressure at 6 and 24 months</measure>
    <time_frame>6 and 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean diastolic blood pressure (DBP) at 6 and 24 months</measure>
    <time_frame>6 and 24 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with normal SBP and DBP</measure>
    <time_frame>6,12, 24 months</time_frame>
    <description>Percentage of patients with SBP&lt;140 mmHg and DBP &lt;90 mmHg at 6, 12 y 24 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL-5D score</measure>
    <time_frame>6,12,24 months</time_frame>
    <description>Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication persistence</measure>
    <time_frame>12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic inertia</measure>
    <time_frame>6,12,24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in lifestyle</measure>
    <time_frame>6,12,24 months</time_frame>
    <description>Changes in lifestyle (smoking, exercise, body weight) at 6, 12, and 24 months compared to these characteristics at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>We will assess if any of the following adverse events are present during the follow-up: angor, myocardial infarction, stroke, hypotensive crisis and death.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health services utilization</measure>
    <time_frame>6,12 and 24 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incremental cost per quality-adjusted life year gained</measure>
    <time_frame>12 months</time_frame>
    <description>Incremental cost per quality-adjusted life year gained in the intervention group as compared to the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with the intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">366</enrollment>
  <condition>Hypertension</condition>
  <condition>Adjustment</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Self-monitoring/Self-titration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will receive routine care for high blood pressure in the primary health care center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-monitoring/Self-titration</intervention_name>
    <description>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:&#xD;
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.&#xD;
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)&#xD;
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.</description>
    <arm_group_label>Self-monitoring/Self-titration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 years or older&#xD;
&#xD;
          -  Diagnosis of hypertension of any origin&#xD;
&#xD;
          -  Systolic blood pressure (SBP) &gt; 145 or diastolic blood pressure (DBP) &gt; 90 mm Hg at&#xD;
             baseline&#xD;
&#xD;
          -  Voluntarily participation in the study and having signed the corresponding informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand and/or perform self-adjustment of the medication, including&#xD;
             dementia or significant cognitive impairment (at the discretion of the investigator&#xD;
             performing the recruitment).&#xD;
&#xD;
          -  History of orthostatic hypotension (fall&gt; 20 mm Hg in SBP after adopting the&#xD;
             orthostatic position).&#xD;
&#xD;
          -  SBP&gt; 200 or DBP&gt; 100 mm Hg on the baseline examination&#xD;
&#xD;
          -  Being on treatment with more than 4 antihypertensive drugs&#xD;
&#xD;
          -  Participation in another study on high blood pressure or in a clinical trial&#xD;
&#xD;
          -  Presence of tremor or neurological disease that makes it difficult to perform BP&#xD;
             self-measurement.&#xD;
&#xD;
          -  Presence of arrhythmia&#xD;
&#xD;
          -  Presence of terminal illness&#xD;
&#xD;
          -  Chronic disability impeding to leave home&#xD;
&#xD;
          -  History of acute cardiovascular event in the last 3 months&#xD;
&#xD;
          -  Hypertension managed directly by specialist physicians outside the primary care&#xD;
             setting.&#xD;
&#xD;
          -  Spouse selected for the study&#xD;
&#xD;
          -  Non-resident or transient patients&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel Sanfélix-Gimeno, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health Services Research Unit FISABIO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departamento de Salud Valencia Clínico Malvarrosa</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para la Investigación del Hospital Clínico de Valencia</investigator_affiliation>
    <investigator_full_name>José Sanfelix</investigator_full_name>
    <investigator_title>Primary Care Physician</investigator_title>
  </responsible_party>
  <keyword>Self-monitoring</keyword>
  <keyword>Education</keyword>
  <keyword>Self-titration</keyword>
  <keyword>antihypertensives</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242785
org study id: ADAMPA
secondary id: 2016-003986-25
nct id: NCT03242785
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Mean systolic blood pressure (SBP).
time frame: 12 months from start of intervention
description: 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
measure: Mean systolic blood pressure at 6 and 24 months
time frame: 6 and 24 months
description: 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
measure: Mean diastolic blood pressure (DBP) at 6 and 24 months
time frame: 6 and 24 months
description: 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
measure: Percentage of patients with normal SBP and DBP
time frame: 6,12, 24 months
description: Percentage of patients with SBP<140 mmHg and DBP <90 mmHg at 6, 12 y 24 months of follow-up
measure: EuroQoL-5D score
time frame: 6,12,24 months
description: Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up
measure: Medication adherence
time frame: 12 months
description: 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.
measure: Medication persistence
time frame: 12 months
description: 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).
measure: Therapeutic inertia
time frame: 6,12,24 months
description: 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.
measure: Changes in lifestyle
time frame: 6,12,24 months
description: Changes in lifestyle (smoking, exercise, body weight) at 6, 12, and 24 months compared to these characteristics at baseline.
measure: Adverse events
time frame: 12 months
description: We will assess if any of the following adverse events are present during the follow-up: angor, myocardial infarction, stroke, hypotensive crisis and death.
measure: Health services utilization
time frame: 6,12 and 24 months
description: 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.
measure: Incremental cost per quality-adjusted life year gained
time frame: 12 months
description: Incremental cost per quality-adjusted life year gained in the intervention group as compared to the control group.
measure: Satisfaction with the intervention
time frame: 12 months
description: Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale.
arm group label: Self-monitoring/Self-titration
arm group type: Experimental
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.
arm group label: Routine care
arm group type: No Intervention
description: Patients in this arm will receive routine care for high blood pressure in the primary health care center.
intervention type: Other
intervention name: Self-monitoring/Self-titration
description: 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.
arm group label: Self-monitoring/Self-titration
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel Sanfélix-Gimeno, Dr
role: Principal Investigator
affiliation: Health Services Research Unit FISABIO
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundación para la Investigación del Hospital Clínico de Valencia
investigator full name: José Sanfelix
investigator title: Primary Care Physician
mesh term: Hypertension
sharing ipd: No