Clinical trial NCT03348878: Descriptive Study of Drug Compliance in Uncontrolled Hypertensive Patients
Official title: Drug Compliance of Patients With Uncontrolled Hypertension Under Treatment: a Pilot Study (Descriptive, Prospective, Monocentric Cohort)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: drug compliance
hypertension
anti-hypertensive agents
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: individual pattern of drug compliance
timeFrame: 2 months of follow-up
Secondary outcomes:
measure: Percentage of Prescribed Dosing Days with Correct Intake
timeFrame: 2 months of follow-up
measure: Percentage of Prescribed Dose Taken
timeFrame: 2 months of follow-up
measure: Percentage of Drug Holidays
timeFrame: 2 months of follow-up
measure: Time Variability in Drug Intake
timeFrame: 2 months of follow-up
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
References: