Heart Failure With Reduced Ejection FractionEDUC-ICNCT05751772
Improving Knowledge in Heart Failure Inpatient With Therapeutic Education
A study testing Patient therapeutic education in people with Heart Failure With Reduced Ejection Fraction and Heart Failure; With Decompensation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Heart Failure; With Decompensation, Pharmacist-Patient Relations
- What is being tested?
- Patient therapeutic education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Dec 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Ability to speak, understand and read in French
- Get a personal telephone
- Consent form signed by the participant
Who cannot join
- Inability to follow study procedures
- Institutionalized persons
- Asylum seekers, homeless people, prisoners
- Incapacity of judgment and discernment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disease and Medication Knowledge Improvement: A Swiss Single-center Randomized Controlled Trial With Heart Failure Inpatients
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.
Read the 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
- Being tested
- Patient therapeutic education
- Keywords
- patient therapeutic education, clinical pharmacy, pharmaceutical care
- Medical subject headings
- Heart Failure, Medication Adherence, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient therapeutic educationOther
Also called inpatient therapeutic education interview and outpatient pharmaceutical follow-up
The pharmacist-led therapeutic education intervention on the knowledge of hospitalized heart failure patients is made by a clinical pharmacist and includes:
- Targeted education on patient needs related to heart failure, heart failure medications and self-care;
- a pre-discharge interview to consolidate key teaching messages and prepare the patient for their discharge treatment plan;
- a telephone call the week of discharge to ensure pharmaceutical follow-up between hospital care and return home (continuity of care, transition of care).
| Study group | Role | What they receive |
|---|---|---|
| "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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Beliefs about medicines will be measured via the specific Beliefs about Medicines Questionnaire (BMQs) score at baseline time (at the inclusion time)(pretest) and at 1 month after hospital discharge (post-test) in both groups.
Scores range from 5 to 25 points for both subscales. The higher the score for the specific need, the more it means that the patient has a strong perception that he needs the drugs to be healthy and live. For specific concerns, the higher the score, the more the patient is concerned about a potential negative effect of taking the medication. A third score can be calculated by subtracting specific concerns from specific needs. This gives a score of -20 to +20. A positive value means that the need for the treatment exceeds the concerns of taking it.
Measured: at the baseline time (zero time),30 days after hospital discharge
Change in Medication Adherence Score
Adherence will be assessed with the Three Item Self Report Scale at baseline time (at the inclusion time) (pre-test) and at 1 month after hospital discharge (post-test) in both groups.
This questionnaire consists of 3 questions; one which evaluates the number of days of forgetting to take medication over the last month, one which evaluates the frequency of taking medication according to medical prescription and the third which makes it possible to measure the level of competence in the correct taking of medication that takes ownership of the patient. Responses are converted on a scale of 0 to 100 (0 is the lowest adherence and 100 the highest). An average of the three answers is used to assign the adhesion score. Higher the score is, better the adherence is.
Measured: at the baseline time (zero time),30 days after hospital discharge
Level of satisfaction on therapeutic education
Patient satisfaction will be assessed using a 13-questions questionnaire specifically developed for this project, after the education interview to assess the usefulness and quality of the teaching intervention. There is no score related to the questionnaire.
This qualitative assessment will allow us to determine whether this new intervention should be continued and to identify its strengths and weaknesses.
Measured: immediately after therapeutic education intervention
Rehospitalization or emergency room visits
The rate of rehospitalization or emergency room visits will be evaluated during the telephone call made by a research assistant at D30 post hospital discharge. The cause of hospitalization will be determined by means of the computerized hospital patient file if he is rehospitalized at the university hospital of Geneva (HUG) or directly to the patient (or his attending physician depending) if he is hospitalized in another hospital. It is interesting to assess whether the patient consumed unplanned care and whether it was related to instability of his heart failure.
Measured: 30 days after hospital discharge
Death at 1 month after discharge
The mortality rate will be assessed in both groups. This information can be collected from the participants' computerized patient records if mentioned or from the participants' relatives or attending physician.
Measured: 30 days after hospital discharge
Patient experiment and feeling after discharge
The patient's experience and feelings upon returning home will be assessed during a telephone call between D3 and D7 after the patient's discharge from the hospital with open questions (no validated questionnaire is used). The objective will be to identify the patient's needs, their feelings about going home, what they liked, what they missed to readjust the counseling to the patient.
Measured: 7 days after hospital discharge
CardioMeds app usability
Use and usability of the mobile smartphone application (CardioMeds® ) will be explored by the research assistant during the telephone call at D30 post hospital discharge using a validated standardized questionnaire (System Usability Scale = SUS).
SUS gives a single score representing a measure composite of the general user-friendliness of the studied service.
The score ranges from 0 to 100.It is generally considered that a score is "good" from 75, fair or fair between 50 and 75. A score below 50 reveals major problems in terms of customer satisfaction.
Measured: 30 days after hospital discharge
Self-Care of Heart Failure Index
Self-care skills of patients using CardioMeds® will be explored using a validated score, the Self-Care of Heart Failure Index composed of 22 questions to measure the effect of this application on patients' level of empowerment in their care. The scale is subdivided in three measurement : maintenance score, management score and self-care confidence score. Each scale score is standardized to a 0 to 100 range. A score of ≥70 can be used as the cut-point to judge self-care adequacy,
Measured: 30 days after hospital discharge
Level of satisfaction on global pharmaceutical care
This second satisfaction questionnaire consisting of 8 questions specifically developed for this project, will be sent at 1 month after hospital discharge to assess the patient's overall satisfaction with the pharmaceutical care follow-up provided. There is no score related to the questionnaire.
This qualitative assessment will allow us to determine whether the hospital pharmaceutical care
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start13 Dec 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Difficulty in recruiting and lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma, Labatec Pharma SA, Bayer, AstraZeneca
- Responsible party
- Principal investigator, Mégane Jermini, University Hospital, Geneva
- Investigators
- Pascal Bonnabry, Professor, Study director, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751772
- Sponsor's protocol ID
- 2022-00731
- Acronym
- EDUC-IC
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (original data sets) that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease and Medication Knowledge Improvement: A Swiss Single-center Randomized Controlled Trial With Heart Failure Inpatients
- ClinicalTrials.gov ID
- NCT05751772
- Acronym / sponsor ID
- EDUC-IC / 2022-00731
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting and lack of resources
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Vifor Pharma, Labatec Pharma SA, Bayer, AstraZeneca
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| "Patient therapeutic education" group | Experimental | Other: Patient therapeutic educationThe 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) |
| "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to follow study procedures
- Institutionalized persons
- Asylum seekers, homeless people, prisoners
- Incapacity of judgment and discernment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient therapeutic educationAlso: inpatient therapeutic education interview and outpatient pharmaceutical follow-upThe 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). | Other | "Patient therapeutic education" group |
Primary outcome
Change in knowledge score
Time frame: at the baseline time (zero time), immediately after therapeutic education intervention and 30 days after hospital discharge
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.
9 secondary outcomes
Change in Beliefs about medicines Score
Time frame: at the baseline time (zero time),30 days after hospital discharge
Change in Medication Adherence Score
Time frame: at the baseline time (zero time),30 days after hospital discharge
Level of satisfaction on therapeutic education
Time frame: immediately after therapeutic education intervention
Rehospitalization or emergency room visits
Time frame: 30 days after hospital discharge
Death at 1 month after discharge
Time frame: 30 days after hospital discharge
Patient experiment and feeling after discharge
Time frame: 7 days after hospital discharge
CardioMeds app usability
Time frame: 30 days after hospital discharge
Self-Care of Heart Failure Index
Time frame: 30 days after hospital discharge
Level of satisfaction on global pharmaceutical care
Time frame: 30 days after hospital discharge
Results and safety
The study was stopped early (reason given: Difficulty in recruiting and lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (original data sets) that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Bonnabry, Professor study director
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient therapeutic education in people with Heart Failure With Reduced Ejection Fraction and Heart Failure; With Decompensation, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting and lack of resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge score (time frame: at the baseline time (zero time), immediately after therapeutic education intervention and 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.