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Nurse-led Educational Intervention on Heart Failure Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Heart failure educational intervention
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Heart failure management programmes, Nurse-led educational interventions, Self-care, Health-related quality of life, Caregiver outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Attikon University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention group 1

Intervention group 2

Control group

Arm Description

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.

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.

Control patients and caregivers will receive usual care for heart failure.

Outcomes

Primary Outcome Measures

Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version

Secondary Outcome Measures

Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6
Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6
Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6
Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6
Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6
Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6
Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6
Time to the first occurrence of a composite of all-cause death or heart failure hospitalization
Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6
Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to 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

Full Information

First Posted
July 26, 2022
Last Updated
July 28, 2022
Sponsor
Attikon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05480969
Brief Title
Nurse-led Educational Intervention on Heart Failure Patients
Official Title
The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
September 14, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure management programmes, Nurse-led educational interventions, Self-care, Health-related quality of life, Caregiver outcomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control patients and caregivers will receive usual care for heart failure.
Intervention Type
Other
Intervention Name(s)
Heart failure educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6
Time Frame
Baseline, month 6
Title
Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6
Time Frame
Baseline, month 6
Title
Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6
Time Frame
Baseline, month 6
Title
Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6
Time Frame
Baseline, month 6
Title
Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6
Time Frame
Baseline, month 6
Title
Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6
Time Frame
Baseline, month 6
Title
Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6
Time Frame
Baseline, month 6
Title
Time to the first occurrence of a composite of all-cause death or heart failure hospitalization
Time Frame
Time from randomization to first occurrence (up to 6 months)
Title
Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6
Time Frame
Baseline, month 6
Title
Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6
Time Frame
Baseline, month 6
Title
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
Time Frame
Baseline, month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerasimos Filippatos, Professor
Organizational Affiliation
2nd Department of Cardiology, Attikon University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Attikon University Hospital
City
Chaidari
State/Province
Attica
ZIP/Postal Code
12461
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Nurse-led Educational Intervention on Heart Failure Patients

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