Heart FailureSupportHeartNCT04415723
A Supportive Care Programme for People With Heart Failure
A study testing supportive care management programme in people with Heart Failure, run by Cyprus University of Technology at 1 site in Cyprus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- supportive care management programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Jan 2019to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Cyprus University of Technology; Nursing Department
Limassol, 3036
Ekaterini Lambrinou, PhD,MSc,BSc, +35799255576, ekaterini.lambrinou@cut.ac.cy
Martha Kyriakou, MSc,BSc, +35799636583, martha_kyriakou@hotmail.com
About this study
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.
- Conditions
- Heart Failure
- Being tested
- supportive care management programme
- Keywords
- heart failure, supportive care, management programme, person-centered care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supportive care management programmeOther
nurse-led management programme
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | supportive care management programme Receives: Other: supportive care management programme |
| control group | No intervention | receive the usual care provided by the health care system of Cyprus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one year
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Jan 2019
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one intervention group one control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterini Lambrinou, Cyprus University of Technology
- Investigators
- Ekaterini Lambrinou, PhD,MSc,BSc, Study director, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415723
- Sponsor's protocol ID
- 0402/2017
- Acronym
- SupportHeart
- Status last verified
- May 2020
- First submitted
- 4 Mar 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only the 2 investigators of the study will share data
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supportive Care Programme for People With Heart Failure
- ClinicalTrials.gov ID
- NCT04415723
- Acronym / sponsor ID
- SupportHeart / 0402/2017
- Conditions
- Heart Failure
- Keywords
- heart failure, supportive care, management programme, person-centered care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one intervention group one control group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: supportive care management programmesupportive care management programme |
| control group | No intervention | –receive the usual care provided by the health care system of Cyprus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supportive care management programmenurse-led management programme | Other | intervention group |
Primary outcome
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
Time frame: Baseline
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)
Time frame: 1st month
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)
Time frame: 3rd month
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)
Time frame: 6th month
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)
Time frame: one year
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)
Time frame: Baseline
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)
Time frame: 1st month
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)
Time frame: 3rd month
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)
Time frame: 6th month
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)
Time frame: one year
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)
Time frame: Baseline
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)
Time frame: 1st month
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)
Time frame: 3rd month
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)
Time frame: 6th month
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)
Time frame: one year
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)
Time frame: Baseline
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)
Time frame: 1st month
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)
Time frame: 3rd month
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)
Time frame: 6th month
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)
Time frame: one year
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)
Time frame: Baseline
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)
Time frame: 1st month
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)
Time frame: 3rd month
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)
Time frame: 6th month
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)
Time frame: one year
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
15 secondary outcomes
Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr
Time frame: Baseline
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Time frame: 1st month
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Time frame: 3rd month
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Time frame: 6th month
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: one year
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
Time frame: Baseline
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
Time frame: 1st month
European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB
Time frame: 3rd month
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
Time frame: 6th month
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No. only the 2 investigators of the study will share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterini Lambrinou, PhD,MSc,BSc study director
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supportive care management programme in people with Heart Failure, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekaterini Lambrinou, BSc,MSc,PhD (+35799255576, ekaterini.lambrinou@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version) (time frame: Baseline). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.