Disease and Medication Knowledge Improvement: A Swiss Single-center Randomized Controlled Trial With Heart Failure Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in knowledge score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to follow study procedures
- •Institutionalized persons
- •Asylum seekers, homeless people, prisoners
- •Incapacity of judgment and discernment
研究组 & 干预措施
"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.
"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)
干预措施: Patient therapeutic education (Other)
结局指标
主要结局
Change in knowledge score
时间窗: 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.
次要结局
- 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)
- Patient experiment and feeling after discharge(7 days after hospital discharge)
- Level of satisfaction on global pharmaceutical care(30 days after hospital discharge)
- Rehospitalization or emergency room visits(30 days after hospital discharge)
- Self-Care of Heart Failure Index(30 days after hospital discharge)
- Death at 1 month after discharge(30 days after hospital discharge)
- CardioMeds app usability(30 days after hospital discharge)
研究者
Mégane Jermini
Hospital and Clinical Pharmacist, pharmD, Principal Investigator
University Hospital, Geneva