<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415723</url>
  </required_header>
  <id_info>
    <org_study_id>0402/2017</org_study_id>
    <nct_id>NCT04415723</nct_id>
  </id_info>
  <brief_title>A Supportive Care Programme for People With Heart Failure</brief_title>
  <acronym>SupportHeart</acronym>
  <official_title>A Supportive Care Programme for People With Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cyprus University of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cyprus University of Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficient health care systems for the management of chronic diseases in the community may&#xD;
      improve clinical outcomes and simultaneously encourage patients to remain healthy. Supportive&#xD;
      care, may contribute to empower heart failure (HF) patients for self- management and&#xD;
      providing them with the follow-up and care based on their needs and values through the HF&#xD;
      trajectory. To develop the current program an assessment of the support needs of HF patients'&#xD;
      will be undertaken and the investigators will take into consideration of their personal&#xD;
      preferences, for instance means of communication and way of exercise as part of the&#xD;
      intervention. The present study aspires to evaluate the effectiveness of an individualized&#xD;
      supportive care management program in terms of the four different components that comprise&#xD;
      supportive care in HF. The objectives of this study are to:&#xD;
&#xD;
        1. Determine supportive care needs of HF patients as reported in the literature.&#xD;
&#xD;
        2. Explore Cypriot patients' identified supportive care needs.&#xD;
&#xD;
        3. To develop and test a self-management supportive care programme for HF patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">January 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>one intervention group one control group</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>single-blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)</measure>
    <time_frame>Baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)</measure>
    <time_frame>1st month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)</measure>
    <time_frame>3rd month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)</measure>
    <time_frame>6th month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)</measure>
    <time_frame>one year</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)</measure>
    <time_frame>Baseline</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)</measure>
    <time_frame>1st month</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)</measure>
    <time_frame>3rd month</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)</measure>
    <time_frame>6th month</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)</measure>
    <time_frame>one year</time_frame>
    <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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)</measure>
    <time_frame>Baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)</measure>
    <time_frame>1st month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)</measure>
    <time_frame>3rd month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)</measure>
    <time_frame>6th month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)</measure>
    <time_frame>one year</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)</measure>
    <time_frame>Baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)</measure>
    <time_frame>1st month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)</measure>
    <time_frame>3rd month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)</measure>
    <time_frame>6th month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)</measure>
    <time_frame>one year</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)</measure>
    <time_frame>Baseline</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)</measure>
    <time_frame>1st month</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)</measure>
    <time_frame>3rd month</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)</measure>
    <time_frame>6th month</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)</measure>
    <time_frame>one year</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr</measure>
    <time_frame>Baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI</measure>
    <time_frame>1st month</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI</measure>
    <time_frame>3rd month</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI</measure>
    <time_frame>6th month</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI</measure>
    <time_frame>one year</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>Baseline</time_frame>
    <description>quantitative data in numerical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1st month</time_frame>
    <description>quantitative data in numerical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>3rd month</time_frame>
    <description>quantitative data in numerical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>6th month</time_frame>
    <description>quantitative data in numerical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>one year</time_frame>
    <description>quantitative data in numerical scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB</measure>
    <time_frame>Baseline</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB</measure>
    <time_frame>1st month</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB</measure>
    <time_frame>3rd month</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB</measure>
    <time_frame>6th month</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB</measure>
    <time_frame>one year</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>supportive care management programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>receive the usual care provided by the health care system of Cyprus</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>supportive care management programme</intervention_name>
    <description>nurse-led management programme</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  clinical diagnoses with HF (HFpEF or HFrEF), established by a cardiologist&#xD;
&#xD;
          -  New York Heart Association classification stages I-IV&#xD;
&#xD;
          -  Diagnosis established for at least 6 months before the start of the intervention&#xD;
             period&#xD;
&#xD;
          -  Ability to understand, write and read in Greek language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuse to take part in the research&#xD;
&#xD;
          -  Dementia or other severe mental illness&#xD;
&#xD;
          -  Transfer to nursing homes after discharge&#xD;
&#xD;
          -  Difficulty in contacting them by a phone call&#xD;
&#xD;
          -  Patients with chronic degenerative diseases (Alzheimer, cancer, etc)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ekaterini Lambrinou, PhD,MSc,BSc</last_name>
    <role>Study Director</role>
    <affiliation>Cyprus University of Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ekaterini Lambrinou, BSc,MSc,PhD</last_name>
    <phone>+35799255576</phone>
    <email>ekaterini.lambrinou@cut.ac.cy</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martha Kyriakou, BSc,MSc</last_name>
    <phone>+35799066032</phone>
    <email>martha_kyriakou@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cyprus University of Technology; Nursing Department</name>
      <address>
        <city>Limassol</city>
        <zip>3036</zip>
        <country>Cyprus</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ekaterini Lambrinou, PhD,MSc,BSc</last_name>
      <phone>+35799255576</phone>
      <email>ekaterini.lambrinou@cut.ac.cy</email>
    </contact>
    <contact_backup>
      <last_name>Martha Kyriakou, MSc,BSc</last_name>
      <phone>+35799636583</phone>
      <email>martha_kyriakou@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Martha Kyriakou, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Cyprus</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>March 4, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cyprus University of Technology</investigator_affiliation>
    <investigator_full_name>Ekaterini Lambrinou</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>supportive care</keyword>
  <keyword>management programme</keyword>
  <keyword>person-centered care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>only the 2 investigators of the study will share data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415723
org study id: 0402/2017
nct id: NCT04415723
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Efficient health care systems for the management of chronic diseases in the community may
      improve clinical outcomes and simultaneously encourage patients to remain healthy. Supportive
      care, may contribute to empower heart failure (HF) patients for self- management and
      providing them with the follow-up and care based on their needs and values through the HF
      trajectory. To develop the current program an assessment of the support needs of HF patients'
      will be undertaken and the investigators will take into consideration of their personal
      preferences, for instance means of communication and way of exercise as part of the
      intervention. The present study aspires to evaluate the effectiveness of an individualized
      supportive care management program in terms of the four different components that comprise
      supportive care in HF. The objectives of this study are to:

        1. Determine supportive care needs of HF patients as reported in the literature.

        2. Explore Cypriot patients' identified supportive care needs.

        3. To develop and test a self-management supportive care programme for HF patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one intervention group one control group
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: single-blinded
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
time frame: Baseline
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.
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
time frame: 1st month
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.
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
time frame: 3rd month
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.
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
time frame: 6th month
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.
measure: Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)
time frame: one year
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.
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
time frame: Baseline
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)
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
time frame: 1st month
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)
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
time frame: 3rd month
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)
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
time frame: 6th month
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)
measure: Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)
time frame: one year
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)
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
time frame: Baseline
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.
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
time frame: 1st month
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.
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
time frame: 3rd month
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.
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
time frame: 6th month
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.
measure: Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)
time frame: one year
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.
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
time frame: Baseline
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.
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
time frame: 1st month
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.
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
time frame: 3rd month
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.
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
time frame: 6th month
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.
measure: Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)
time frame: one year
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.
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
time frame: Baseline
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
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
time frame: 1st month
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
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
time frame: 3rd month
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
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
time frame: 6th month
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
measure: International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)
time frame: one year
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
measure: Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr
time frame: Baseline
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.
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
time frame: 1st month
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.
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
time frame: 3rd month
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.
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
time frame: 6th month
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.
measure: Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI
time frame: one year
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.
measure: 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
description: quantitative data in numerical scale
measure: 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
description: quantitative data in numerical scale
measure: 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
description: quantitative data in numerical scale
measure: 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
description: quantitative data in numerical scale
measure: 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
description: quantitative data in numerical scale
measure: European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
time frame: Baseline
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
measure: European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
time frame: 1st month
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
measure: European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB
time frame: 3rd month
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
measure: European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB
time frame: 6th month
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
measure: European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB
time frame: one year
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
arm group label: intervention group
arm group type: Experimental
description: supportive care management programme
arm group label: control group
arm group type: No Intervention
description: receive the usual care provided by the health care system of Cyprus
intervention type: Other
intervention name: supportive care management programme
description: nurse-led management programme
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ekaterini Lambrinou, PhD,MSc,BSc
role: Study Director
affiliation: Cyprus University of Technology
last name: Ekaterini Lambrinou, BSc,MSc,PhD
phone: +35799255576
email: ekaterini.lambrinou@cut.ac.cy
last name: Martha Kyriakou, BSc,MSc
phone: +35799066032
email: martha_kyriakou@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Cyprus
responsible party type: Principal Investigator
investigator affiliation: Cyprus University of Technology
investigator full name: Ekaterini Lambrinou
investigator title: Associate Professor
mesh term: Heart Failure
sharing ipd: No
ipd description: only the 2 investigators of the study will share data