- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242785
Impact of Self-monitoring of Blood Pressure and Self-titration of Medication in the Control of Hypertension (ADAMPA) (ADAMPA)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Valencia, Spain
- Departamento de Salud Valencia Clínico Malvarrosa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
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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.
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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:
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No Intervention: Routine care
Patients in this arm will receive routine care for high blood pressure in the primary health care center.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean systolic blood pressure (SBP).
Time Frame: 12 months from start of intervention
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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
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12 months from start of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean systolic blood pressure at 6 and 24 months
Time Frame: 6 and 24 months
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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
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6 and 24 months
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Mean diastolic blood pressure (DBP) at 6 and 24 months
Time Frame: 6 and 24 months
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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
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6 and 24 months
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Percentage of patients with normal SBP and DBP
Time Frame: 6,12, 24 months
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Percentage of patients with SBP<140 mmHg and DBP <90 mmHg at 6, 12 y 24 months of follow-up
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6,12, 24 months
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EuroQoL-5D score
Time Frame: 6,12,24 months
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Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up
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6,12,24 months
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Medication adherence
Time Frame: 12 months
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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.
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12 months
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Medication persistence
Time Frame: 12 months
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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).
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12 months
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Therapeutic inertia
Time Frame: 6,12,24 months
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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.
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6,12,24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in lifestyle
Time Frame: 6,12,24 months
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Changes in lifestyle (smoking, exercise, body weight) at 6, 12, and 24 months compared to these characteristics at baseline.
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6,12,24 months
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Adverse events
Time Frame: 12 months
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We will assess if any of the following adverse events are present during the follow-up: angor, myocardial infarction, stroke, hypotensive crisis and death.
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12 months
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Health services utilization
Time Frame: 6,12 and 24 months
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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.
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6,12 and 24 months
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Incremental cost per quality-adjusted life year gained
Time Frame: 12 months
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Incremental cost per quality-adjusted life year gained in the intervention group as compared to the control group.
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12 months
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Satisfaction with the intervention
Time Frame: 12 months
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Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale.
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Gabriel Sanfélix-Gimeno, Dr, Health Services Research Unit FISABIO
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADAMPA
- 2016-003986-25 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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