A Supportive Care Programme for People With Heart Failure

NCT04415723 | Unknown DMC

• 1 other identifier: 0402/2017
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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:

1. 1.Determine supportive care needs of HF patients as reported in the literature.
2. 2.Explore Cypriot patients' identified supportive care needs.
3. 3.To develop and test a self-management supportive care programme for HF patients.

Conditions

Heart Failure

Keywords

heart failure; supportive care; management programme; person-centered care

Outcome Measures

Primary Outcomes (25)

• Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)

  Quantitative data. MLHFQ consists of 21 items using a six-point Likert scale (scored 0-5), resulting in a total score in the range of 0-105, with higher scores reflecting poorer quality of life.

  Baseline

• Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)

  quantitative data The items of the questionnaire examines 3 dimentions. The dimension scores were calculated as the sum of the items that represent each dimension. Higher scores indicate worse quality of life.

  1st month

• Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)

  Quantitative data. MLHFQ consists of 21 items using a six-point Likert scale (scored 0-5), resulting in a total score in the range of 0-105, with higher scores reflecting poorer quality of life.

  3rd month

• Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)

  Quantitative data. MLHFQ consists of 21 items using a six-point Likert scale (scored 0-5), resulting in a total score in the range of 0-105, with higher scores reflecting poorer quality of life.

  6th month

• Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version)

  Quantitative data. MLHFQ consists of 21 items using a six-point Likert scale (scored 0-5), resulting in a total score in the range of 0-105, with higher scores reflecting poorer quality of life.

  one year

• Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)

  quantitative data Individual domains of the questionnaire and Average Weighted Impact Score of the indivudual domains scores show maximum negative impact of diabetes (-9) and maximum positive impact of diabetes (+3)

  Baseline

• Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)

  quantitative data Individual domains of the questionnaire and Average Weighted Impact Score of the indivudual domains scores show maximum negative impact of diabetes (-9) and maximum positive impact of diabetes (+3)

  1st month

• Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)

  quantitative data Individual domains of the questionnaire and Average Weighted Impact Score of the indivudual domains scores show maximum negative impact of diabetes (-9) and maximum positive impact of diabetes (+3)

  3rd month

• Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)

  quantitative data Individual domains of the questionnaire and Average Weighted Impact Score of the indivudual domains scores show maximum negative impact of diabetes (-9) and maximum positive impact of diabetes (+3)

  6th month

• Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version)

  quantitative data Individual domains of the questionnaire and Average Weighted Impact Score of the indivudual domains scores show maximum negative impact of diabetes (-9) and maximum positive impact of diabetes (+3)

  one year

• Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)

  Quantitative data MSPSS consists of 12 items using a six-point Likert scale (scored 1-7), resulting in a total score in the range of 12-84.The dimension scores were calculated as the summation of the items that repreresent each dimenson \[ 1. Family/Significant others , 2. Friends\] . Higher scores indicate higher perceived social support by Friends and Family/Signifciant Others.

  Baseline

• Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)

  Quantitative data MSPSS consists of 12 items using a six-point Likert scale (scored 1-7), resulting in a total score in the range of 12-84.The dimension scores were calculated as the summation of the items that repreresent each dimenson \[ 1. Family/Significant others , 2. Friends\] . Higher scores indicate higher perceived social support by Friends and Family/Signifciant Others.

  1st month

• Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)

  Quantitative data MSPSS consists of 12 items using a six-point Likert scale (scored 1-7), resulting in a total score in the range of 12-84.The dimension scores were calculated as the summation of the items that repreresent each dimenson \[ 1. Family/Significant others , 2. Friends\] . Higher scores indicate higher perceived social support by Friends and Family/Signifciant Others.

  3rd month

• Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)

  Quantitative data MSPSS consists of 12 items using a six-point Likert scale (scored 1-7), resulting in a total score in the range of 12-84.The dimension scores were calculated as the summation of the items that repreresent each dimenson \[ 1. Family/Significant others , 2. Friends\] . Higher scores indicate higher perceived social support by Friends and Family/Signifciant Others.

  6th month

• Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version)

  Quantitative data MSPSS consists of 12 items using a six-point Likert scale (scored 1-7), resulting in a total score in the range of 12-84.The dimension scores were calculated as the summation of the items that repreresent each dimenson \[ 1. Family/Significant others , 2. Friends\] . Higher scores indicate higher perceived social support by Friends and Family/Signifciant Others.

  one year

• Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)

  Quantitative data The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate worse quality of life.

  Baseline

• Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)

  Quantitative data The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate worse quality of life.

  1st month

• Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)

  Quantitative data The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate worse quality of life.

  3rd month

• Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)

  Quantitative data The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate worse quality of life.

  6th month

• Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version)

  Quantitative data The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher scores indicate worse quality of life.

  one year

• International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)

  quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level

  Baseline

• International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)

  quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level

  1st month

• International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)

  quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level

  3rd month

• International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)

  quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level

  6th month

• International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version)

  quantitative data In the classification of perceived physical activity via the IPAQ there were three categories ˙ low activity level, moderate activity and high activity level

  one year

Secondary Outcomes (15)

• Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr

  Baseline

• Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI

  1st month

• Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI

  3rd month

• Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI

  6th month

• Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI

  one year

Study Arms (2)

intervention group

EXPERIMENTAL

supportive care management programme

Other: supportive care management programme

control group

NO INTERVENTION

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

Interventions

supportive care management programme OTHER

nurse-led management programme

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Cyprus University of Technology; Nursing Department

Limassol, 3036, Cyprus

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ekaterini Lambrinou, PhD,MSc,BSc

  Cyprus University of Technology

  STUDY DIRECTOR

Central Study Contacts

Ekaterini Lambrinou, BSc,MSc,PhD

CONTACT

+35799255576; ekaterini.lambrinou@cut.ac.cy

Martha Kyriakou, BSc,MSc

CONTACT

+35799066032; martha_kyriakou@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single-blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: one intervention group one control group

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: June 4, 2020
• Study Start: January 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2022
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)