Heart FailureNCT05480969
Nurse-led Educational Intervention on Heart Failure Patients
A study testing Heart failure educational intervention in people with Heart Failure, run by Attikon Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart failure educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteGreece
- Study dates
- 19 Apr 2019to 14 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Men or women aged ≥18 years old.
- Hospitalized for new-onset or decompensated chronic heart failure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure
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.
- Conditions
- Heart Failure
- Being tested
- Heart failure educational intervention
- Keywords
- Heart failure management programmes, Nurse-led educational interventions, Self-care, Health-related quality of life, Caregiver outcomes
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart failure educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Heart failure educational intervention |
| 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. Receives: Other: Heart failure educational intervention |
| Control group | No intervention | Control patients and caregivers will receive usual care for heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version
Measured: Baseline, 6 months
Secondary outcomes (11)
Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6
Measured: Baseline, month 6
Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6
Measured: Baseline, month 6
Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6
Measured: Baseline, month 6
Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6
Measured: Baseline, month 6
Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6
Measured: Baseline, month 6
Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6
Measured: Baseline, month 6
Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6
Measured: Baseline, month 6
Time to the first occurrence of a composite of all-cause death or heart failure hospitalization
Measured: Time from randomization to first occurrence (up to 6 months)
Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6
Measured: Baseline, month 6
Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6
Measured: 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
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start19 Apr 2019
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Thodi, Attikon Hospital
- Investigators
- Gerasimos Filippatos, Professor, Study chair, 2nd Department of Cardiology, Attikon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480969
- Sponsor's protocol ID
- 28/18-01-2019
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36510826
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT05480969
- Acronym / sponsor ID
- 28/18-01-2019
- Conditions
- Heart Failure
- Keywords
- Heart failure management programmes, Nurse-led educational interventions, Self-care, Health-related quality of life, Caregiver outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Other: Heart failure educational interventionHeart 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. |
| Intervention group 2 | Experimental | Other: Heart failure educational interventionHeart 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 group | No intervention | –Control patients and caregivers will receive usual care for heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Men or women aged ≥18 years old.
- Hospitalized for new-onset or decompensated chronic heart failure.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart failure educational interventionEducational 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. | Other | Intervention group 1, Intervention group 2 |
Primary outcome
Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version
Time frame: Baseline, 6 months
11 secondary outcomes
Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6
Time frame: Baseline, month 6
Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6
Time frame: Baseline, month 6
Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6
Time frame: Baseline, month 6
Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6
Time frame: Baseline, month 6
Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6
Time frame: Baseline, month 6
Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6
Time frame: Baseline, month 6
Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6
Time frame: Baseline, month 6
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)
Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6
Time frame: Baseline, month 6
Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6
Time frame: 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
Time frame: Baseline, month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 36510826Thodi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerasimos Filippatos, Professor study chair
2nd Department of Cardiology, Attikon University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart failure educational intervention in people with Heart Failure, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05480969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.