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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
supportive care management programme
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, supportive care, management programme, person-centered care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cyprus University of Technology; Nursing DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

supportive care management programme

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
March 4, 2020
Last Updated
May 31, 2020
Sponsor
Cyprus University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04415723
Brief Title
A Supportive Care Programme for People With Heart Failure
Acronym
SupportHeart
Official Title
A Supportive Care Programme for People With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, supportive care, management programme, person-centered care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one intervention group one control group
Masking
InvestigatorOutcomes Assessor
Masking Description
single-blinded
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
supportive care management programme
Arm Title
control group
Arm Type
No Intervention
Arm Description
receive the usual care provided by the health care system of Cyprus
Intervention Type
Other
Intervention Name(s)
supportive care management programme
Intervention Description
nurse-led management programme
Primary Outcome Measure Information:
Title
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
Description
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.
Time Frame
Baseline
Title
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
Description
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.
Time Frame
1st month
Title
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
Description
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.
Time Frame
3rd month
Title
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
Description
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.
Time Frame
6th month
Title
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
Description
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.
Time Frame
one year
Title
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
Description
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)
Time Frame
Baseline
Title
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
Description
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)
Time Frame
1st month
Title
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
Description
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)
Time Frame
3rd month
Title
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
Description
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)
Time Frame
6th month
Title
Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
Description
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)
Time Frame
one year
Title
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
Description
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.
Time Frame
Baseline
Title
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
Description
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.
Time Frame
1st month
Title
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
Description
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.
Time Frame
3rd month
Title
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
Description
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.
Time Frame
6th month
Title
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
Description
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.
Time Frame
one year
Title
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
Description
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.
Time Frame
Baseline
Title
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
Description
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.
Time Frame
1st month
Title
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
Description
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.
Time Frame
3rd month
Title
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
Description
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.
Time Frame
6th month
Title
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
Description
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.
Time Frame
one year
Title
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
Description
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
Time Frame
Baseline
Title
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
Description
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
Time Frame
1st month
Title
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
Description
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
Time Frame
3rd month
Title
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
Description
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
Time Frame
6th month
Title
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
Description
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
Time Frame
one year
Secondary Outcome Measure Information:
Title
Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr
Description
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.
Time Frame
Baseline
Title
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Description
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.
Time Frame
1st month
Title
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Description
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.
Time Frame
3rd month
Title
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Description
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.
Time Frame
6th month
Title
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Description
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.
Time Frame
one year
Title
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.
Description
quantitative data in numerical scale
Time Frame
Baseline
Title
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.
Description
quantitative data in numerical scale
Time Frame
1st month
Title
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.
Description
quantitative data in numerical scale
Time Frame
3rd month
Title
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.
Description
quantitative data in numerical scale
Time Frame
6th month
Title
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.
Description
quantitative data in numerical scale
Time Frame
one year
Title
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
Description
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
Time Frame
Baseline
Title
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
Description
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
Time Frame
1st month
Title
European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB
Description
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
Time Frame
3rd month
Title
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
Description
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
Time Frame
6th month
Title
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
Description
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterini Lambrinou, BSc,MSc,PhD
Phone
+35799255576
Email
ekaterini.lambrinou@cut.ac.cy
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Kyriakou, BSc,MSc
Phone
+35799066032
Email
martha_kyriakou@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterini Lambrinou, PhD,MSc,BSc
Organizational Affiliation
Cyprus University of Technology
Official's Role
Study Director
Facility Information:
Facility Name
Cyprus University of Technology; Nursing Department
City
Limassol
ZIP/Postal Code
3036
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekaterini Lambrinou, PhD,MSc,BSc
Phone
+35799255576
Email
ekaterini.lambrinou@cut.ac.cy
First Name & Middle Initial & Last Name & Degree
Martha Kyriakou, MSc,BSc
Phone
+35799636583
Email
martha_kyriakou@hotmail.com
First Name & Middle Initial & Last Name & Degree
Martha Kyriakou, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only the 2 investigators of the study will share data

Learn more about this trial

A Supportive Care Programme for People With Heart Failure

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