Nurse-led Educational Intervention on Heart Failure Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Heart failure educational intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group 1<br>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. | Other: Heart failure educational intervention<br>* 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.<br>|
| Experimental: Intervention group 2<br>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. | Other: Heart failure educational intervention<br>* 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.<br>|
| No Intervention: Control group<br>Control patients and caregivers will receive usual care for heart failure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure management programmes, Nurse-led educational interventions, Self-care, Health-related quality of life, Caregiver outcomes