Clinical trial NCT05751772: Improving Knowledge in Heart Failure Inpatient With Therapeutic Education
Official title: Disease and Medication Knowledge Improvement: A Swiss Single-center Randomized Controlled Trial With Heart Failure Inpatients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Heart Failure; With Decompensation
Pharmacist-Patient Relations
Medication Adherence
Knowledge, Attitudes, Practice
Keywords: patient therapeutic education
clinical pharmacy
pharmaceutical care
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
name: Labatec Pharma SA
name: Bayer
name: AstraZeneca
First posted: 2023-03-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective is to evaluate the impact of a pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients. The knowledge score on heart failure disease and medications will be compared between two groups one month after hospitalization. The intervention group will receive a therapeutic education intervention and usual hospital care and the control group will receive only usual hospital care.

Detailed description: Heart failure patients are at risk of decompensation of their disease and frequent hospitalizations. Poor adherence to their treatment may be the cause. By improving the knowledge of hospitalized heart failure patients about their disease and their medications, it is expected that these patients will adhere better to their heart failure drug therapy and benefit from a better effectiveness of their treatment. This could promote an improvement in their quality of life, a decrease in their risk of disease complications and even an increase in their life expectancy.

The objective of this research project is to deploy a therapeutic teaching intervention at the bedside of decompensated and hospitalized heart failure patients, associated with follow-up by the pharmacist at discharge from the hospital, and to measure its impact on knowledge change (primary endpoint), on their beliefs about medications, on their therapeutic adherence, and on the consumption of unplanned care such as rehospitalizations and emergency room visits (secondary endpoints).

Eligibility criteria: Inclusion Criteria:

* Hospitalization in the Department of General Internal Medicine or Cardiology for decompensated heart failure with lowered left ventricular ejection fraction (LVEF) (≤40%) from any cause or mildly lowered LVEF (41-49%) with the presence of heart failure-specific drug therapy
* Stability of the patient's clinical condition
* ≥ 2 heart failure medications
* ≥18 years
* Full capacity of discernment
* Absence of cognitive impairment
* Ability to speak, understand and read in French
* Get a personal telephone
* Consent form signed by the participant

Exclusion Criteria:

* Inability to follow study procedures
* Institutionalized persons
* Asylum seekers, homeless people, prisoners
* Incapacity of judgment and discernment

Primary outcomes:
measure: Change in knowledge score
timeFrame: at the baseline time (zero time), immediately after therapeutic education intervention and 30 days after hospital discharge
Secondary outcomes:
measure: Change in Beliefs about medicines Score
timeFrame: at the baseline time (zero time),30 days after hospital discharge
measure: Change in Medication Adherence Score
timeFrame: at the baseline time (zero time),30 days after hospital discharge
measure: Level of satisfaction on therapeutic education
timeFrame: immediately after therapeutic education intervention
measure: Rehospitalization or emergency room visits
timeFrame: 30 days after hospital discharge
measure: Death at 1 month after discharge
timeFrame: 30 days after hospital discharge
measure: Patient experiment and feeling after discharge
timeFrame: 7 days after hospital discharge
measure: CardioMeds app usability
timeFrame: 30 days after hospital discharge
measure: Self-Care of Heart Failure Index
timeFrame: 30 days after hospital discharge
measure: Level of satisfaction on global pharmaceutical care
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: University of Geneva
name: Pascal Bonnabry, Professor
role: STUDY_DIRECTOR
References: