A Supportive Care Programme for People With Heart Failure (SupportHeart)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Other: supportive care management programme

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Limassol, Cyprus, 3036
    • Recruiting
    • Cyprus University of Technology; Nursing Department
    • Contact: Ekaterini Lambrinou, PhD,MSc,BSc; Phone Number: +35799255576; Email: ekaterini.lambrinou@cut.ac.cy
    • Contact: Martha Kyriakou, MSc,BSc; Phone Number: +35799636583; Email: martha_kyriakou@hotmail.com
    • Sub-Investigator: Martha Kyriakou, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; supportive care management programme	Other: supportive care management programme; nurse-led management programme
No Intervention: control group; receive the usual care provided by the health care system of Cyprus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)	Quantitative 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.	Baseline
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)	quantitative data The items of the questionnaire examines 3 dimentions. The dimension scores were calculated as the sum of the items that represent each dimension. Higher scores indicate worse quality of life.	1st month
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)	Quantitative 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.	3rd month
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)	Quantitative 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.	6th month
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)	Quantitative 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.	one year
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)	quantitative 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)	Baseline
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)	quantitative 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)	1st month
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)	quantitative 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)	3rd month
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)	quantitative 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)	6th month
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)	quantitative 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)	one year
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)	Quantitative 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.	Baseline
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)	Quantitative 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.	1st month
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)	Quantitative 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.	3rd month
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)	Quantitative 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.	6th month
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)	Quantitative 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.	one year
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)	Quantitative 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.	Baseline
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)	Quantitative 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.	1st month
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)	Quantitative 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.	3rd month
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)	Quantitative 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.	6th month
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)	Quantitative 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.	one year
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)	quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level	Baseline
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)	quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level	1st month
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)	quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level	3rd month
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)	quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level	6th month
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)	quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr	Quantitative 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.	Baseline
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI	Quantitative 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.	1st month
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI	Quantitative 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.	3rd month
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI	Quantitative 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.	6th month
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI	Quantitative 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.	one year
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.	quantitative data in numerical scale	Baseline
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.	quantitative data in numerical scale	1st month
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.	quantitative data in numerical scale	3rd month
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.	quantitative data in numerical scale	6th month
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.	quantitative data in numerical scale	one year
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB	Quantitative 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	Baseline
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB	Quantitative 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	1st month
European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB	Quantitative 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	3rd month
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB	Quantitative 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	6th month
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB	Quantitative 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	one year

Collaborators and Investigators

• Sponsor: Cyprus University of Technology
• Investigators: Study Director: Ekaterini Lambrinou, PhD,MSc,BSc, Cyprus University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): January 15, 2022

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: May 31, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 31, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: heart failure; supportive care; person-centered care; management programme
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0402/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only the 2 investigators of the study will share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No