About this trial
Heart failure (HF) is an incurable and complex disease syndrome with sophisticated disease trajectories. The guideline for HF management suggests that treatment should include adequate education to help patients have better self-management ability, and improve their quality of life and prognosis. However, how to provide massive amount of HF patients a continuous, complete and individualized disease care education from hospitalization, post-discharge, to home for months is a difficult problem. This study plans to develop an automated and intelligent education system for HF on the mobile device "Line" platform. Through this platform, we hope to make the HF education continuous for 3 months from hospital to post-discharge period. We hypothesize that (1) this intervention can improve knowledge, self-care, emotional stress, self-efficacy, quality of life and disease outcomes in patients of HF; (2) the system developed in this study can reduce the hours of nursing work while improve the quality of education and become the best clinical auxiliary education tool.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a diagnosis of heart failure
Patients with age >= 20 years old
patients with clear consciousness
Patients who can communicate with by Chinese or Taiwanese, and are willing to participate this study
Disqualifiers
patients who are long-term bedridden, or living dependent of others
patients who have severe psychological disease, or severe cognitive dysfunction
patients without utilizing smartphone or internet
Trial design
Parallel
Treatments tested in this trial
accepting the operation process of automated intelligent education software system
Behavioral1. Execute registration and qualification review 2. Automated smart education interaction
Treatment groups
Trial outcomes
Primary outcomes
Composite events of one-year Re-Hospitalization and all-cause death
Follow-up begins after enroll. Follow-up data are prospectively obtained every month from hospital records, personal communication with patients' physicians, telephone interviews, and records of regular visits to staff physicians' outpatient clinics. All-cause death is chosen as an endpoint because of the inter- relationship of heart failure with many other comorbidities in the patient cohort. Re-hospitalization is defined as a re-hospitalization due to worsening heart failure. In the statistical analysis for outcomes, composite events combining heart failure-related re-hospitalization and all-cause death will be estimated. Based on these two different endpoints, time to the first event was analyzed.
Heart Failure knowledge scale
The HF knowledge scale has 15 questions, self-administered questionnaire that covers items concerning HF knowledge in general, knowledge on HF treatment (including diet and fluid restriction) and HF symptoms and symptom recognition. For each item, patients can choose from three options, with one of the options being the correct answer. The scale has a minimum score of 0 (no knowledge) and a maximum score of 15 points (optimal knowledge).
Self-Care of Heart Failure Index (SCHFI)
SCHFI Version 6.2 has 22 items rated on a 4-point response scale, and divided into the following three scales: self-care maintenance, self-care management, and self-care confidence. The total score for each separate scale is standardized from zero to 100. Higher scores indicating higher contribution to self-care.
Hospital anxiety and depression scale (HADS)
The hospital anxiety and depression scale has 14 items. Seven of the items indicate anxiety and the remaining seven items indicate depression. The answer format offers four response options, which are scored with values ranging from 0 to 3. This results in scale values between 0 and 21 for each scale. The original test authors defined three ranges for both of the scales: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21(cases).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.