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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
| Labatec Pharma SA | INDUSTRY |
| Bayer | INDUSTRY |
| AstraZeneca |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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) |
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| "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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Bonnabry, Professor | University of Geneva, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Geneva | Geneva | 1205 | Switzerland |
Individual participant data (original data sets) that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
Start immediately following publication. No end date.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2022 |
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Single-center randomized controlled trial
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| 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. | 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. | 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. | 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. | 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. | 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. | 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, | 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 | 30 days after hospital discharge |
| Nov 4, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2022 | Dec 23, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D055118 | Medication Adherence |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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