Mobile Education System to Improve Disease Knowledge, Self-efficacy and Quality of Life in Patients With Heart Failure

NCT06161649 | Recruiting

• 1 other identifier: 202201890B0
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Heart failure; automation; smart mobile education system; disease knowledge; self-care; emotional stress; self-efficacy; quality of life

Outcome Measures

Primary Outcomes (7)

• 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.

  1 year

• 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).

  6 month

• 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.

  6 month

• 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).

  6 month

• Cardiac Self efficacy questionnaire

  The core self-evaluations scale has 13 questions. A 5-point Likert scale was used, ranging from 1 (not at all confident) to 5 (very confident), a higher score indicates higher cardiac self-efficacy. Each question asks the patient to rate their level of confidence that using a five-point Likert scale. A score of 1 indicates "not at all", 2 "somewhat confident", 3 "moderately confident", 4 "very confident", and 5 "completely confident". The cardiac self-efficacy questionnaire has 13 items and the total score range is 0 to 65 points, with higher scores indicating greater self-efficacy.

  6 month

• Minnesota Living With Heart Failure questionnaire

  The MLHF questionnaire is a disease-specific questionnaire designed to measure quality of life in patients with heart failure. This questionnaire is scored using a 5-point Likert scale and includes two subscales that address the physical and emotional domains, respectively. The questionnaire aims to reveal how patients feel about the changes in life caused by heart failure and symptom treatment during the past 1-month period. Each of the 21 questions in the questionnaire is scored from 0 to 5, with the total score range for the MLHF ranging from 0 to 105. Higher scores correlate with poorer quality of life.

  6 month

• Service satisfaction scale

  The service satisfaction scale was developed by the researcher to understand the subjects' satisfaction with the use of the automated mobile education system or traditional outpatient care. It has 10 questions in total.

  6 month

Study Arms (2)

traditional outpatient care group

NO INTERVENTION

After confirming that the diagnosis of heart failure is met, the patient will receive 10-15 minutes of disease care education from a nurse when the patient receives the case. At the same time, the patient will receive a personal disease self-care education manual, and will get the contact number of the case manager in case the patients encounter emergencies or disease care needs at home (the patient can call for consultation on home care for diseases if the patient want).

automated mobile education system group

EXPERIMENTAL

Intervention group (accepting the operation process of automated intelligent education software system): 1. Execute registration and qualification review 2. Automated smart education interaction At the same time, the patient will receive a personal disease self-care education manual, and will get the contact number of the case manager in case the patients encounter emergencies or disease care needs at home (the patient can call for consultation on home care for diseases if the patient want).

Behavioral: accepting the operation process of automated intelligent education software system

Interventions

accepting the operation process of automated intelligent education software system BEHAVIORAL

1. Execute registration and qualification review 2. Automated smart education interaction

automated mobile education system group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, Taiwan

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Heart Failure; Stress, Psychological

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• MIN-HUI LIU, RN, PhD

  CHANG GUNG MEMORIAL HOSTIPAL, KEELUNG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MIN-HUI LIU, RN, PhD

CONTACT

0224313131; min4108@cgmh.org.tw

CHAO-HUNG WANG, MD, PhD

CONTACT

0221313131; bearty@cmgh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Heart Failure Center

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 8, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)