Improving Knowledge in Heart Failure Inpatient With Therapeutic Education

NCT ID: NCT05751772

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-13
• Study Completion Date: 2024-01-31

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).

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure; With Decompensation; Pharmacist-Patient Relations; Medication Adherence; Knowledge, Attitudes, Practice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

"Patient therapeutic education" group

The intervention group will benefit from a pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients and usual hospital care (medical and nursing care)

Group Type: EXPERIMENTAL

Patient therapeutic education

Intervention Type: OTHER

The pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients is made by a clinical pharmacist and includes:

1. Targeted education on patient needs related to heart failure, heart failure medications and self-care;

2. a pre-discharge interview to consolidate key teaching messages and prepare the patient for their discharge treatment plan;

3. a telephone call the week of discharge to ensure pharmaceutical follow-up between hospital care and return home (continuity of care, transition of care).

"Usual hospital care" group

The control group do only benefit from the usual hospital care (any medical and nursing care giving to an acute heart failure inpatient) and won't benefit from the pharmacist's educational intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient therapeutic education

The pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients is made by a clinical pharmacist and includes:

1. Targeted education on patient needs related to heart failure, heart failure medications and self-care;

2. a pre-discharge interview to consolidate key teaching messages and prepare the patient for their discharge treatment plan;

3. a telephone call the week of discharge to ensure pharmaceutical follow-up between hospital care and return home (continuity of care, transition of care).

Intervention Type: OTHER

Other Intervention Names

inpatient therapeutic education interview and outpatient pharmaceutical follow-up

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

Labatec Pharma SA

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Mégane Jermini

Hospital and Clinical Pharmacist, pharmD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pascal Bonnabry, Professor

Role: STUDY_DIRECTOR

University of Geneva

Locations

University Hospital of Geneva

Geneva, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-00731

Identifier Type: -

Identifier Source: org_study_id