Therapeutic Adherence in Uncontrolled Arterial Hypertension

NCT04464746 | Completed

• 1 other identifier: ATHAN
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

In hypertension, highly prevalent, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite being treated with ≥3 drugs, which is known as resistant hypertension. Resistant arterial hypertension, together with difficult-to-control hypertension, has a worse cardiovascular prognosis than controlled hypertension. In addition, data on therapeutic adherence in arterial hypertension show that 1 in 2 hypertensive patients do not fully or partially comply with the indicated therapeutic prescription. The determination of antihypertensive drugs or their metabolites in urine seems to be a good indicator of therapeutic adherence. On the other hand, the implementation of a specific program to improve knowledge of the disease and its risks and promote therapeutic adherence could improve the control of hypertension and reduce the associated morbidity and mortality.

Conditions

Treatment Adherence

Outcome Measures

Primary Outcomes (1)

• Change in 24h-systolic blood pressure.

  Comparison between groups of change in 24-hour-systolic blood pressure provided by 24h-ambulatory blood pressure monitoring 3 months after randomization

  3 months

Secondary Outcomes (1)

• Variation in the degree of therapeutic compliance

  3 months

Study Arms (2)

Control

NO INTERVENTION

usual medical follow-up

Intervention

ACTIVE COMPARATOR

Implementation of a specific program to improve therapeutic adherence

Other: implementation of a specific program to improve therapeutic adherence

Interventions

implementation of a specific program to improve therapeutic adherence OTHER

1. Discussion of risks associated with high BP;aims,healthy lifestyle options. 2. Individualized educational intervention:verbal, written,audiovisual information. Evaluation of knowledge of prescribed drugs. 3. Behavioral counseling.training patients to participate in their own care, while positively modifying their skills or routines (i.e. pill boxes,calendars,specific measures to remind the patient taking drugs,adapt the regimen to atient's daily routine). 4. Socio-psycho-affective interventions. 5. Reminder systems: phone,email,alarm on the mobile phone. 6. Simplification as far as possible of therapeutic scheme. 7. Explanation of prescribed medications (name\&dosage), correct intake. 8. Explanation of possible side effects and what to do if they happen. Facilitate a contact. 9. Advise and training on home blood pressure self-measurement. 10. Verbal, written and/or audiovisual information and the online patients'section of scientific societies addresses will be provided.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥18 years
• diagnosis of resistant hypertension with treatment superior to 3 drugs at maximum dose, one of them being a diuretic
• uncontrolled hypertension treated with 2 drugs at the maximum effective doses tolerated
• the prescribed treatment must be stable for the last 2 months
• given informed consent

You may not qualify if:

• secondary arterial hypertension
• pregnant women
• Impossibility to perform a 24-hour blood pressure monitoring, or poor quality results.
• Recent history of major vascular episode
• patients receiving treatment with Barnidipino / Felodipine / Lercanidipine / Manidipine / Nifedipine / Verapamil / Eplerenone

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are not knowledged whether they are allocated to the control group or to the interventional group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hypertension & Vascular Risk Unit. Nephrology Department

Model Details: Interventional, prospective, randomized, controlled, parallel groups, open study

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: July 9, 2020
• Study Start: July 1, 2018
• Primary Completion: December 20, 2023
• Study Completion: December 31, 2023
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)