Heart Failure and Reduced Ejection FractionNCT07660237
Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure
A study testing Structured Transitional Care Program in people with Heart Failure and Reduced Ejection Fraction and Transitional Care, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction, Transitional Care
- What is being tested?
- Structured Transitional Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jul 2023to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure: A Randomized Controlled Trial
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.
Read the detailed description
Heart failure is a chronic condition associated with frequent hospitalizations, poor self-care behaviors, psychological distress, and reduced quality of life. Patients with heart failure often experience depression and inadequate self-management after hospital discharge, which may negatively affect treatment adherence and clinical outcomes.
Transitional care programs have been developed to improve continuity of care and support patients during the transition from hospital to home. Structured transitional care interventions may enhance patients' self-efficacy and self-care abilities while reducing depressive symptoms.
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. Eligible participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive a structured transitional care program in addition to usual care, whereas the control group will receive usual care only.
Outcomes including depression, self-efficacy, and self-care behaviors will be measured before discharge and at 1 and 3 months after discharge using validated assessment instruments.
- Being tested
- Structured Transitional Care Program, Usual Care
- Keywords
- Depression, Self-Efficacy, Self-Care
- Medical subject headings
- Heart Failure, Systolic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Transitional Care ProgramBehavioural
A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
Usual CareOther
Participants received standard discharge routine care provided by the hospital after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Transitional Care Program Group | Experimental | Participants received a structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge. Receives: Behavioral: Structured Transitional Care Program |
| Usual Care Group | Active comparator | Participants received routine discharge education and standard follow-up care provided by the hospital after dischar Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
Measured: 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)
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).
Measured: 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)
Self-care behaviors will be assessed using the Self-Care of Heart Failure Index (SCHFI).
Measured: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start19 Jul 2023
- Primary completion18 Jan 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure and Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the structured transitional care program group or the usual care group in a parallel design.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Shan Yeh, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660237
- Sponsor's protocol ID
- 202300968B0
- Status last verified
- May 2026
- First submitted
- 12 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07660237
- Acronym / sponsor ID
- 202300968B0
- Keywords
- Depression, Self-Efficacy, Self-Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure is a chronic condition associated with frequent hospitalizations, poor self-care behaviors, psychological distress, and reduced quality of life. Patients with heart failure often experience depression and inadequate self-management after hospital discharge, which may negatively affect treatment adherence and clinical outcomes.
Transitional care programs have been developed to improve continuity of care and support patients during the transition from hospital to home. Structured transitional care interventions may enhance patients' self-efficacy and self-care abilities while reducing depressive symptoms.
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. Eligible participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive a structured transitional care program in addition to usual care, whereas the control group will receive usual care only.
Outcomes including depression, self-efficacy, and self-care behaviors will be measured before discharge and at 1 and 3 months after discharge using validated assessment instruments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the structured transitional care program group or the usual care group in a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Transitional Care Program Group | Experimental | Behavioral: Structured Transitional Care ProgramParticipants received a structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge. |
| Usual Care Group | Active comparator | Other: Usual CareParticipants received routine discharge education and standard follow-up care provided by the hospital after dischar |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Transitional Care ProgramA structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge. | Behavioural | Transitional Care Program Group |
| Usual CareParticipants received standard discharge routine care provided by the hospital after discharge. | Other | Usual Care Group |
Primary outcome
Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)
Time frame: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).
Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)
Time frame: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
Self-care behaviors will be assessed using the Self-Care of Heart Failure Index (SCHFI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Transitional Care Program in people with Heart Failure and Reduced Ejection Fraction and Transitional Care, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.