Clinical trial NCT04415723: A Supportive Care Programme for People With Heart Failure
Official title: A Supportive Care Programme for People With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
supportive care
management programme
person-centered care
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one intervention group one control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
timeFrame: Baseline
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
timeFrame: 1st month
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
timeFrame: 3rd month
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
timeFrame: 6th month
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
timeFrame: one year
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
timeFrame: Baseline
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
timeFrame: 1st month
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
timeFrame: 3rd month
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
timeFrame: 6th month
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
timeFrame: one year
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
timeFrame: Baseline
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
timeFrame: 1st month
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
timeFrame: 3rd month
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
timeFrame: 6th month
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
timeFrame: one year
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
timeFrame: Baseline
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
timeFrame: 1st month
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
timeFrame: 3rd month
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
timeFrame: 6th month
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
timeFrame: one year
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
timeFrame: 1st month
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
timeFrame: 3rd month
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
timeFrame: 6th month
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
timeFrame: one year
Secondary outcomes:
measure: Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr
timeFrame: Baseline
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
timeFrame: 1st month
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
timeFrame: 3rd month
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
timeFrame: 6th month
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
timeFrame: one year
measure: Number of acute events and deterioration Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge.
timeFrame: Baseline
measure: Number of acute events and deterioration Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge.
timeFrame: 1st month
measure: Number of acute events and deterioration Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge.
timeFrame: 3rd month
measure: Number of acute events and deterioration Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge.
timeFrame: 6th month
measure: Number of acute events and deterioration Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge.
timeFrame: one year
measure: European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
timeFrame: Baseline
measure: European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
timeFrame: 1st month
measure: European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB
timeFrame: 3rd month
measure: European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
timeFrame: 6th month
measure: European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
timeFrame: one year
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Cyprus University of Technology; Nursing Department
Study officials:
affiliation: Cyprus University of Technology
name: Ekaterini Lambrinou, PhD,MSc,BSc
role: STUDY_DIRECTOR
References: