A Supportive Care Programme for People With Heart Failure

Study Overview
=================
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: Determine supportive care needs of HF patients as reported in the literature. Explore Cypriot patients' identified supportive care needs. To develop and test a self-management supportive care programme for HF patients.

Official Title
-----------------
A Supportive Care Programme for People With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: supportive care management programme


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one intervention group one control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>supportive care management programme | Other: supportive care management programme<br>* nurse-led management programme<br>|
| No Intervention: control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, supportive care, management programme, person-centered care