A Supportive Care Programme for People With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: supportive care management programme
- Registration Number
- NCT04415723
- Lead Sponsor
- Cyprus University of Technology
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group supportive care management programme supportive care management programme
- Primary Outcome Measures
Name Time Method Audit of Diabetes Dependent Quality of Life - 19 Items ADDQoL-19 (Gr version) 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)
Hospital and Anxiety- Depression Scale (Greek Version) HADS (Gr version) 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.
Minnessota Living with Heart Failure Questionnaire (Greek Version) MLHFQ (Gr version) 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.
International Physical Activity Questionnaire (Greek Version) IPAQ (Gr version) 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
Multidimensional Scale of Perceived Social Support (Greek Version) MSPSS (Gr version) 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.
- Secondary Outcome Measures
Name Time Method European Heart Failure Self-Care Behavior Scale - Gr9 (Greek version) Grg-EHFScB 3rd month 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
Self -Care of Heart Failure Index (Greek Version) Gr-SCHFI one year 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.
European Heart Failure Self-Care Behavior Scale- Gr9 (Greek version) Grg-EHFScB 6th month 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
Self -Care of Heart Failure Index (Greek Version) SCHFI -Gr Baseline Quantitative data The SCHFI -Gr consists of 22 items representing 3 dimensions. The dimension scores were calculated as the sum of the items that represent each dimension. The negative item 8 was reversed coded before the calculation. Increased scores indicates higher self care management.
Number of acute events and deterioration Despite advances in treatment, the prognosis of HF remains poor, accounting for 10% mortality rate after an acute event and 20-25% of patients will be readmitted within the first month after discharge. one year quantitative data in numerical scale
European Heart Failure Self-Care Behavior Scale - Gr9(Greek version) Grg-EHFScB one year 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
Trial Locations
- Locations (1)
Cyprus University of Technology; Nursing Department
🇨🇾Limassol, Cyprus