Descriptive Study of Drug Compliance in Uncontrolled Hypertensive Patients

Uncontrolled Hypertension Clinical Trial

— THERMO-HTA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03348878
• Other study ID #: 69HCL17_0325
• Status: Terminated
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: March 23, 2022

Study information

• Verified date: June 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Other:
• assessment of drug compliance
assessment of drug compliance using electronic monitoring devices (2 months duration)

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	individual pattern of drug compliance	compliance measurement using electronic monitoring devices	2 months of follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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