Descriptive Study of Drug Compliance in Uncontrolled Hypertensive Patients (THERMO-HTA)

Drug Compliance of Patients With Uncontrolled Hypertension Under Treatment: a Pilot Study (Descriptive, Prospective, Monocentric Cohort)

Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.

In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.

For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.

Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.

Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.

Study Overview

• Status: Terminated
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Other: assessment of drug compliance

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hôpital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient treated with diuretics and / or beta-blockers and / or calcium-blockers and / or ACE inhibitors and / or sartans
• Holter blood pressure total average of 24h greater than 135/85 mmHg or a daytime average greater than 140/90 mmHg or a nighttime average greater than 125/75 mmHg.
• informed consent given

Exclusion Criteria:

• Adults with severe hypertension (BP ≥ 180/110 mmHg) with or without organ failure requiring therapeutic adaptation
• Adults unable to comply with study procedures
• Patients who do not wish to receive generic drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cohort of uncontrolled hypertensive patients	Other: assessment of drug compliance; assessment of drug compliance using electronic monitoring devices (2 months duration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
individual pattern of drug compliance	compliance measurement using electronic monitoring devices	2 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Prescribed Dosing Days with Correct Intake	The percentage of days with accurate dose intake is defined according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.	2 months of follow-up
Percentage of Prescribed Dose Taken	This measure, though often close to the previous one, focuses on the dose actually received and is defined according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.	2 months of follow-up
Percentage of Drug Holidays	We define a "drug holiday" as a period of one or more days without drug intake (that is, without MEMS (Medication Event Monitoring System) opening). The statistic counts the number of gaps among the prescribed days, ignoring the length of each individual gap, according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.	2 months of follow-up
Time Variability in Drug Intake	summary measures consider only the number of medication events each day, according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.	2 months of follow-up

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: hypertension; anti-hypertensive agents; drug compliance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 69HCL17_0325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No