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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group 1 | Experimental | Heart failure educational sessions will be provided by the heart failure-trained nurse to patients and caregivers. These will be delivered through a combination of home visits and telephone calls performed at regular time intervals for a total period of 6 months. |
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| Intervention group 2 | Experimental | Heart failure educational sessions will be provided by the heart failure-trained nurse to patients and caregivers. These will be delivered through telephone calls performed at regular time intervals for a total period of 6 months. |
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| Control group | No Intervention | Control patients and caregivers will receive usual care for heart failure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart failure educational intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Self-Care of Heart Failure Index (SCHFI) (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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerasimos Filippatos, Professor | 2nd Department of Cardiology, Attikon University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University Hospital | Chaïdári | Attica | 12461 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36510826 | Derived | Thodi M, Bistola V, Lambrinou E, Keramida K, Nikolopoulos P, Parissis J, Farmakis D, Filippatos G. A randomized trial of a nurse-led educational intervention in patients with heart failure and their caregivers: impact on caregiver outcomes. Eur J Cardiovasc Nurs. 2023 Oct 19;22(7):709-718. doi: 10.1093/eurjcn/zvac118. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 exercise capacity (6 minute walking test - 6MWT) 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 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 |