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

Hypertension Clinical Trial

— ADAMPA  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242785
• Other study ID #: ADAMPA
• Secondary ID: 2016-003986-25
• Status: Completed
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: August 25, 2020

Study information

• Verified date: August 2021
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: August 25, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Adjustment
• Hypertension

Intervention

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: 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.

Locations

Country	Name	City	State
Spain	Departamento de Salud Valencia Clínico Malvarrosa	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	Carlos III Health Institute, Spanish Clinical Research Network - SCReN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in lifestyle	Changes in lifestyle (smoking, exercise, body weight) at 6, 12, and 24 months compared to these characteristics at baseline.	6,12,24 months
Other	Adverse events	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
Other	Health services utilization	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
Other	Incremental cost per quality-adjusted life year gained	Incremental cost per quality-adjusted life year gained in the intervention group as compared to the control group.	12 months
Other	Satisfaction with the intervention	Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale.	12 months
Primary	Mean systolic blood pressure (SBP).	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	Mean systolic blood pressure at 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
Secondary	Mean diastolic blood pressure (DBP) at 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
Secondary	Percentage of patients with normal SBP and DBP	Percentage of patients with SBP<140 mmHg and DBP <90 mmHg at 6, 12 y 24 months of follow-up	6,12, 24 months
Secondary	EuroQoL-5D score	Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up	6,12,24 months
Secondary	Medication adherence	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
Secondary	Medication persistence	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
Secondary	Therapeutic inertia	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