Improving Knowledge in Heart Failure Inpatient With Therapeutic Education

NCT05751772 | Terminated DMC

• 1 other identifier: 2022-00731
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in knowledge score

  Patients' level of knowledge about their disease and heart failure medications before the educational pharmaceutical intervention (pre-test) and immediately after the intervention (post-test n° 1) for the intervention group , as well as at 1 month after hospital discharge (post-test n°2) for the intervention and control group. It will be measured by means of a 17-question questionnaire specifically developed for this project. This level is valued by a minimum score of 0 points and a maximum of 17 points. Higher score means a better level of knowledge. The positive difference between pre-test and post-tes means an increase in knowledge and a negative difference means a decrease in knowledge.

  at the baseline time (zero time), immediately after therapeutic education intervention and 30 days after hospital discharge

Secondary Outcomes (9)

• Change in Beliefs about medicines Score

  at the baseline time (zero time),30 days after hospital discharge

• Change in Medication Adherence Score

  at the baseline time (zero time),30 days after hospital discharge

• Level of satisfaction on therapeutic education

  immediately after therapeutic education intervention

• Rehospitalization or emergency room visits

  30 days after hospital discharge

• Death at 1 month after discharge

  30 days after hospital discharge

Study Arms (2)

"Patient therapeutic education" group

EXPERIMENTAL

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)

Other: Patient therapeutic education

"Usual hospital care" group

NO INTERVENTION

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.

Interventions

Patient therapeutic education 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).

Also known as: inpatient therapeutic education interview and outpatient pharmaceutical follow-up

"Patient therapeutic education" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Vifor Pharma: collaborator
• Labatec Pharma SA: collaborator
• Bayer: collaborator
• AstraZeneca: collaborator

Study Sites (1)

University Hospital of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Heart Failure; Medication Adherence; Behavior

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Pascal Bonnabry, Professor

  University of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital and Clinical Pharmacist, pharmD, Principal Investigator

Model Details: Single-center randomized controlled trial

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: March 2, 2023
• Study Start: December 13, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start immediately following publication. No end date.
• Access Criteria: With whom? Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For what type of analysis? For individual participant data meta-analysis. How to access to available data? Proposals should be directed to megane.jermini@hcuge.ch or megane.jermini@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available in University of Geneva's data warehouse (Yareta data depository) but without investigator support other than deposited metadata.

Locations

CH (1)