Heart Failure
Conditions
Keywords
Heart failure management programmes, Nurse-led educational interventions, Self-care, Health-related quality of life, Caregiver outcomes
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.
Interventions
OTHERHeart failure educational intervention
Educational intervention constitutes of a face-to-face session delivered before hospital discharge and outpatient sessions on regular intervals for a total of 6 months. Outpatient sessions in Intervention group 1 constitute of two home-based sessions on months 1 and 3, combined with weekly telephone calls during month 1 and bi-weekly calls during months 2-6. Outpatient sessions in Intervention group-2 constitute of weekly telephone sessions during month 1 and bi-weekly calls during months 2-6. The pre-discharge session will address self-monitoring and health awareness. Education will be provided by in-person discussion and through printed supporting material. Caregiver education will include understanding heart failure and advice on how to support their patient, manage their own health and well-being and how to get help when needed. During outpatient sessions, repeat education will be done and evaluation of implementation of self-care activities.
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version | Baseline, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 the Self-rating Depression Scale-SDS (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 Self-Care of Heart Failure Index (SCHFI) (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 |
| 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 in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6 | Baseline, month 6 |
| Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (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 |
Countries
Greece
Outcome results
None listed