Impact of self-measurement of blood pressure and self-adjustment of antihypertensive medication in the control of hypertension and adherence to treatment. A pragmatic, randomized, controlled clinical trial (ADAMPA Study)

Phase 1

• Conditions: Arterial hypertension; MedDRA version: 19.1Level: LLTClassification code 10020775Term: Hypertension arterialSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003986-25-ES
• Lead Sponsor: Instituto de Investigación Sanitaria INCLIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-17
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

- 40 years or older
- have a diagnosis of hypertension of any origin
- have a TAS> 145 or TAD> 90 mm Hg on the baseline examination
- voluntarily agree to participate in the study and sign the corresponding informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

- inability to self-care of their blood pressure, understanding, performing and / or self-adjusting of medication by the patient, including dementia or significant cognitive impairment at the discretion of the investigator performing the recruitment
- history of orthostatic hypotension (fall> 20 mm Hg in systolic arterial tension after the orthostatic position)
- have a blood pressure> 200 or diastolic blood pressure> 100 mm Hg at baseline
- being on treatment with more than 4 antihypertensive drugs
- be included in another high blood pressure study or in a clinical trial
- presence of tremor or neurological disease that makes it difficult to perform AMPA
- presence of arrhythmia
- presence of terminal illness
- chronic incapacitation to leave your home
- have had an acute cardiovascular event in the last 3 months
- arterial hypertension managed directly by specialist physicians outside the Primary Care setting
- spouse selected for the study
- non-resident or transient patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effectiveness of an intervention based on self-monitoring and self-adjustment of medication in poorly controlled hypertensive patients.;Secondary Objective: - Evaluate its impact on adherence to treatments, lifestyles, quality of life, occurrence of adverse events, use of health services, and costs of care.<br>- Estimate its efficiency (cost-effectiveness).<br>- Evaluate the visions and experiences of patients, caregivers and health professionals about self-management, self-monitoring and self-adjustment of antihypertensive medication;Primary end point(s): Difference in mean systolic blood pressure, in mmHg, at 12 months follow-up between the intervention and control groups, determined in consultation with a validated automatic electronic sphygmomanometer;Timepoint(s) of evaluation of this end point: 12 months