CompletedNot Applicable

Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure

Taiwan130 participantsStarted 2023-07-19

Plain-language summary

This randomized controlled trial aims to evaluate the effects of a structured transitional care program on depression, self-efficacy, and self-care behaviors in patients with heart failure. Outcomes will be assessed before discharge and at 1 and 3 months after discharge.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients with a diagnosis of heart failure confirmed by a specialist physician. Patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤40%. Age ≥20 years. Clear consciousness and no cognitive impairment. Ability to communicate in Mandarin, Taiwanese, or Hakka. Ability to complete the questionnaire independently or with assistance from the researcher. Exclusion Criteria: Patients who are unable to be discharged during the current hospitalization. Severe consciousness impairment, cognitive impairment, or severe mental illness affecting study participation. Patients who are illiterate or unable to express themselves verbally. Patients who are bedridden long-term or unable to perform self-care activities. Patients who refuse to participate in the study. Patients who are already enrolled in a case management program.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)

Timeframe: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)

Timeframe: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)

Timeframe: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

Trial details

NCT IDNCT07660237

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-18

View on ClinicalTrials.gov More Heart Failure and Reduced Ejection Fraction trials

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)

Timeframe: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)

Timeframe: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.

Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)

Timeframe: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.