A Supportive Care Programme for People With Heart Failure

NCT ID: NCT04415723

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2022-01-15

Brief Summary

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Efficient health care systems for the management of chronic diseases in the community may improve clinical outcomes and simultaneously encourage patients to remain healthy. Supportive care, may contribute to empower heart failure (HF) patients for self- management and providing them with the follow-up and care based on their needs and values through the HF trajectory. To develop the current program an assessment of the support needs of HF patients' will be undertaken and the investigators will take into consideration of their personal preferences, for instance means of communication and way of exercise as part of the intervention. The present study aspires to evaluate the effectiveness of an individualized supportive care management program in terms of the four different components that comprise supportive care in HF. The objectives of this study are to:

1. Determine supportive care needs of HF patients as reported in the literature.
2. Explore Cypriot patients' identified supportive care needs.
3. To develop and test a self-management supportive care programme for HF patients.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one intervention group one control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
single-blinded

Study Groups

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intervention group

supportive care management programme

Group Type EXPERIMENTAL

supportive care management programme

Intervention Type OTHER

nurse-led management programme

control group

receive the usual care provided by the health care system of Cyprus

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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supportive care management programme

nurse-led management programme

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* clinical diagnoses with HF (HFpEF or HFrEF), established by a cardiologist
* New York Heart Association classification stages I-IV
* Diagnosis established for at least 6 months before the start of the intervention period
* Ability to understand, write and read in Greek language

Exclusion Criteria

* Refuse to take part in the research
* Dementia or other severe mental illness
* Transfer to nursing homes after discharge
* Difficulty in contacting them by a phone call
* Patients with chronic degenerative diseases (Alzheimer, cancer, etc)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cyprus University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Ekaterini Lambrinou

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ekaterini Lambrinou, PhD,MSc,BSc

Role: STUDY_DIRECTOR

Cyprus University of Technology

Locations

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Cyprus University of Technology; Nursing Department

Limassol, , Cyprus

Site Status RECRUITING

Countries

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Cyprus

Central Contacts

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Ekaterini Lambrinou, BSc,MSc,PhD

Role: CONTACT

+35799255576

Martha Kyriakou, BSc,MSc

Role: CONTACT

+35799066032

Facility Contacts

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Ekaterini Lambrinou, PhD,MSc,BSc

Role: primary

+35799255576

Martha Kyriakou, MSc,BSc

Role: backup

+35799636583

Other Identifiers

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0402/2017

Identifier Type: -

Identifier Source: org_study_id

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