Nurse-led Educational Intervention on Heart Failure Patients
Not Applicable
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT05480969
- Lead Sponsor
- Attikon Hospital
- Brief Summary
A randomized controlled study to examine the effect of a nurse-led, home/telephone or telephone-only educational intervention on outcomes of heart failure patients and their caregivers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
- Written informed consent
- Men or women aged ≥18 years old.
- Hospitalized for new-onset or decompensated chronic heart failure.
Exclusion Criteria
- Any severe neuromuscular disease or other disability or mobility problems that preclude performance of six-minute walk test.
- Any severe cognitive dysfunction or psychiatric disease that limit ability to receive education.
- Patients unable to be contacted by phone or other means.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version Baseline, 6 months
- Secondary Outcome Measures
Name Time Method Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6 Baseline, month 6 Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6 Baseline, month 6 Change in the EuroQol Health-Related Quality of Life Questionnaire EQ-5D three-level version (EQ-5D-3L) (Greek version) from baseline to month 6 Baseline, month 6 Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6 Baseline, month 6 Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6 Baseline, month 6 Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6 Baseline, month 6 Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6 Baseline, month 6 Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6 Baseline, month 6 Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6 Baseline, month 6 Time to the first occurrence of a composite of all-cause death or heart failure hospitalization Time from randomization to first occurrence (up to 6 months) Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6 Baseline, month 6
Trial Locations
- Locations (1)
Attikon University Hospital
🇬🇷Chaidari, Attica, Greece
Attikon University Hospital🇬🇷Chaidari, Attica, Greece