Chronic Heart Failure
Conditions
Keywords
Heart Failure, Self-Care, Patient Education, Nurse-Led Intervention, Teach-Back, Clinical Stability, Medication Adherence, Randomized Controlled Trial, Post-Discharge Care
Brief summary
Heart failure is a chronic condition that can lead to frequent hospitalizations and reduced quality of life. This study aims to evaluate whether a nurse-led, face-to-face educational intervention can improve clinical stability, treatment compliance, and self-care behaviors among patients with heart failure after hospital discharge. Participants will be randomly assigned to either the intervention group, receiving a structured 30-minute educational session using the teach-back method, or the control group, receiving standard follow-up care. The primary outcome is clinical stability at three months, assessed using the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care and medication compliance measured up to 12 months. The study will be conducted at the ASST di Lodi Heart Failure Clinic in Italy and is expected to last three years.
Detailed description
Heart failure (HF) is a progressive chronic condition associated with high rates of readmission, mortality, and impaired quality of life. Adherence to therapy and self-care behaviors play a key role in maintaining clinical stability, yet many patients struggle to apply recommended management strategies after hospital discharge. This randomized controlled trial (EDUCATE study) aims to assess the effectiveness of a nurse-led, face-to-face educational intervention on clinical stability, treatment compliance, and self-care in patients with HF during the post-discharge period. The intervention consists of a 30-minute educational session conducted by trained nurses during the first outpatient cardiology visit, approximately 30 days after discharge. The session includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials from Penn Nursing Science. A follow-up reinforcement phone call will be made one month later, and the educational session will be repeated at six months. Participants will be randomly assigned (1:1) to either the intervention or control group. The control group will receive standard follow-up care, including monthly telephone contacts to support medication adherence and symptom monitoring. The primary outcome is clinical stability at three months, measured by the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care (Self-Care of Heart Failure Index 7.2) and medication compliance (Morisky 4-item Scale), assessed at 3, 6, 9, and 12 months. The study will be conducted at the Heart Failure Clinic of ASST di Lodi, Italy, with an anticipated enrollment of 118 participants. The total study duration is 36 months, including 24 months of recruitment and 12 months of follow-up for the last enrolled participant.
Interventions
BEHAVIORALNurse-Led Face-to-Face Educational Intervention (Teach-Back Method)
A 30-minute structured educational session delivered by trained nurses during the first outpatient cardiology visit (about 30 days after discharge). The intervention includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials from Penn Nursing Science. A reinforcement phone call will be conducted one month later, and the session repeated at six months.
Sponsors
Azienda Socio Sanitaria Territoriale di Lodi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Intervention model description
This is a single-center, open-label, randomized controlled trial with a 1:1 allocation ratio. Participants will be assigned to either the intervention group, receiving a structured nurse-led educational session using the teach-back method, or the control group, receiving standard follow-up care. Outcomes will be assessed at 3, 6, 9, and 12 months after enrollment.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Hospital discharge from the Cardiology Unit of Lodi Hospital with a diagnosis of heart failure according to international guidelines * NYHA functional class II-IV assigned at discharge * First outpatient cardiology visit scheduled 30 (±15) days after hospital discharge * Ability and willingness to provide written informed consent
Exclusion criteria
* Severe cognitive impairment (Six Item Screener score 0-3) * Admission from a unit other than the Cardiology Department of Lodi Hospital * NYHA class I * First cardiology visit scheduled \<30 or \>45 days after discharge * Previous enrollment or follow-up in any Heart Failure Clinic * Acute coronary event within the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Stability at 3 Months | 3 months after the first outpatient cardiology visit. | Clinical stability will be assessed using the Heart Failure Somatic Perception Scale (HFSPS). The scale measures symptom perception in heart failure. A difference of at least 7 points between intervention and control groups (favoring the intervention) is hypothesized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Care Lavels | 3, 6, 9, and 12 months after the first outpatient cardiology visit | Self-care behaviors will be assessed using the Self-Care of Heart Failure Index version 7.2 (SCHFI 7.2). Higher scores indicate better self-care; scores \>70 are considered adequate. |
| Medication Compliance | 3, 6, 9, and 12 months after the first outpatient cardiology visit | Medication adherence will be measured with the 4-item Morisky Scale. A total score of 4 indicates high adherence. The proportion of participants reporting full adherence (No to all items) will be compared between groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 3, 6, 9, and 12 months after the first outpatient cardiology visit | Health-related quality of life will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Higher scores indicate better perceived quality of life and lower symptom burden. |
Countries
Italy
Contacts
Primary ContactGreta Ghizzardi, Ph.D.
Backup ContactStefano Maiandi, Ph.D.
Outcome results
None listed