Skip to content

A Supportive Care Programme for People With Heart Failure

A Supportive Care Programme for People With Heart Failure

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04415723
Acronym
SupportHeart
Enrollment
200
Registered
2020-06-04
Start date
2019-01-15
Completion date
2022-01-15
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, supportive care, management programme, person-centered 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.

Interventions

OTHERsupportive care management programme

nurse-led management programme

Sponsors

Cyprus University of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

single-blinded

Intervention model description

one intervention group one control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)BaselineQuantitative data. MLHFQ consists of 21 items using a six-point Likert scale (scored 0-5), resulting in a total score in the range of 0-105, with higher scores reflecting poorer quality of life.
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)Baselinequantitative data Individual domains of the questionnaire and Average Weighted Impact Score of the indivudual domains scores show maximum negative impact of diabetes (-9) and maximum positive impact of diabetes (+3)
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)BaselineQuantitative data MSPSS consists of 12 items using a six-point Likert scale (scored 1-7), resulting in a total score in the range of 12-84.The dimension scores were calculated as the summation of the items that repreresent each dimenson \[ 1. Family/Significant others , 2. Friends\] . Higher scores indicate higher perceived social support by Friends and Family/Signifciant Others.
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)BaselineQuantitative data The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate worse quality of life.
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)Baselinequantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level

Secondary

MeasureTime frameDescription
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI1st monthQuantitative data The SCHFI -Gr consists of 22 items representing 3 dimensions. The dimension scores were calculated as the sum of the items that represent each dimension. The negative item 8 was reversed coded before the calculation. Increased scores indicates higher self care management.
European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB3rd monthQuantitative data. EHFScBS-Gr9 is a 5-point Likert scale, from 1 to 5.The total score is calculated by summing the ratings for each item. The total score ranges from 0 to 45 with higher scores indicating poorer self-care behaviors. For the purposes of this program all items will be reversed coded so as higher score is associated with a higher level of self care management
Self -Care of Heart Failure Index (Greek Version) SCHFI -GrBaselineQuantitative data The SCHFI -Gr consists of 22 items representing 3 dimensions. The dimension scores were calculated as the sum of the items that represent each dimension. The negative item 8 was reversed coded before the calculation. Increased scores indicates higher self care management.
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.Baselinequantitative data in numerical scale
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScBBaselineQuantitative data. EHFScBS-Gr9 is a 5-point Likert scale, from 1 to 5.The total score is calculated by summing the ratings for each item. The total score ranges from 0 to 45 with higher scores indicating poorer self-care behaviors. For the purposes of this program all items will be reversed coded so as higher score is associated with a higher level of self care management
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB1st monthQuantitative data. EHFScBS-Gr9 is a 5-point Likert scale, from 1 to 5.The total score is calculated by summing the ratings for each item. The total score ranges from 0 to 45 with higher scores indicating poorer self-care behaviors. For the purposes of this program all items will be reversed coded so as higher score is associated with a higher level of self care management

Countries

Cyprus

Contacts

Primary ContactEkaterini Lambrinou, BSc,MSc,PhD
ekaterini.lambrinou@cut.ac.cy+35799255576
Backup ContactMartha Kyriakou, BSc,MSc
martha_kyriakou@hotmail.com+35799066032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026