Heart FailureNCT07068308
Effects of a Wed-based FRAIL-SM Program Among Patients With Heart Failure
A study testing web-based FRAIL-SM program in people with Heart Failure, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study aims to examine the effects of web-based FRAIL-SM (Family involvement, self-Regulation skills training, Autonomy, Information sharing and Linkage, Self-Management) on frailty, self-management behaviors and quality of life in patients with heart failure and their families' heart failure knowledge… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- web-based FRAIL-SM program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged above 20.
- Diagnosed with heart failure or LVEF<40%.
- Clear consciousness, can communicate with Chinese and Taiwanese.
- Consent to join in this study and have family partner.
- Access to computer or smartphone
- Meet one of the Study of Osteoporotic Fractures of frailty
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- Aged above 20.
- Clear consciousness, can communicate with Chinese and Taiwanese.
- Consent to join in this study and willing to accompany with patients.
- Access to computer or smartphone
Who cannot join
- Bed-ridden or unable to perform activities of daily living independently.
- Diagnosed with cognitive, psychiatric disease, or major depression.
- Acute disease condition e.g. infection or thrombosis.
- Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
- severe neurodegenerative or muscular diseases, e.g. parkinson's disease, arthritis.
- Family criteria:
Show all 9Show fewer
- Bed-ridden or unable to perform activities of daily living independently.
- Diagnosed with cognitive, psychiatric disease, or major depression.
- Have employment relationship with patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Yang Ming Chiao Tung University
Taipei, 112
Ai-Fu Chiou Professor, PhD, 886-2-28267354, afchiou@nycu.edu.tw
About this study
Official title: Development and Effectiveness of a Wed-based FRAIL-SM Program Among Patients With Heart Failure
This study aims to examine the effects of web-based FRAIL-SM (Family involvement, self-Regulation skills training, Autonomy, Information sharing and Linkage, Self-Management) on frailty, self-management behaviors and quality of life in patients with heart failure and their families' heart failure knowledge, confidence, strain, and quality of life. Patients are recruited with a convenience sampling from two medical centers in Taiwan. The web-based FRAIL-SM includes Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage.
Read the detailed description
A randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group by stratified randomization according to participation of post-acute care. Patients in the intervention group will receive an 8-week web-based FRAIL-SM program. Data is collected by researchers using a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, and quality of life and physical indicators such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment.
- Conditions
- Heart Failure
- Being tested
- web-based FRAIL-SM program
- Keywords
- frailty, heart failure, self-management, web-based frailty self-management program, knowledge, family caregiver, quality of life
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based FRAIL-SM programBehavioural
The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.
| Study group | Role | What they receive |
|---|---|---|
| wed-based FRAIL-SM program | Experimental | Patients in the intervention group will receive an 8-week web-based FRAIL-SM program including family involvement, self-regulation, autonomy support, information sharing and linkage. Receives: Behavioral: web-based FRAIL-SM program |
| control group | No intervention | Patients in this group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Frailty Assessment Scale for Heart Failure scores
Changes from baseline Frailty Assessment Scale for Heart Failure scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Frailty Assessment Scale for Heart Failure contains 15 items, each item use Likert scale four point scoring (0-3), the total scores ranged from 0 to 45, the higher scores indicate higher levels of frailty.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes in Dutch Heart Failure Knowledge Scale scores
Changes from baseline Dutch Heart Failure Knowledge Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Dutch Heart Failure Knowledge Scale contains 15 items. The total scores ranged from 0 to 15, the higher scores indicate higher levels of knowledge.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes in Self-Care of Heart Failure Index scores
Changes from baseline Self-Care of Heart Failure Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Self-Care of Heart Failure Index contains 22 items, three subscales: self-care maintenance, self-care management, self-care confidence. Each subscale scores ranged from 0 to 100, the higher scores indicate higher levels of self-care maintenance, self-care management, self-care confidence.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes in Minnesota Living with Heart Failure questionnaire scores
Changes from baseline Minnesota Living with Heart Failure questionnaire scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Minnesota Living with Heart Failure questionnaire contains 21 items, each item scores ranged from 0 to 5. The total socre ranged from 0 to 105, the higher scores indicate higher levels of impact on quality of life.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary outcomes (2)
Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores
Changes from baseline World Health Organization Quality of Life - BREF (WHOQOL-BREF) Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The WHOQOL-BREF scale contains 28 items, four dimensions. Each dimension scores ranged from 4 to 20, the higher scores indicate higher levels of quality of life.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes in Caregiver Strain Index scores
Changes from baseline Caregiver Strain Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Scale contains 13 items, the total scores ranged from 0 to 13, the higher scores indicate higher levels of strain.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068308
- Sponsor's protocol ID
- NYCU113069AE
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness of a Wed-based FRAIL-SM Program Among Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07068308
- Acronym / sponsor ID
- NYCU113069AE
- Conditions
- Heart Failure
- Keywords
- frailty, heart failure, self-management, web-based frailty self-management program, knowledge, family caregiver, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 16 Jul 2025 (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 study aims to examine the effects of web-based FRAIL-SM (Family involvement, self-Regulation skills training, Autonomy, Information sharing and Linkage, Self-Management) on frailty, self-management behaviors and quality of life in patients with heart failure and their families' heart failure knowledge, confidence, strain, and quality of life. Patients are recruited with a convenience sampling from two medical centers in Taiwan. The web-based FRAIL-SM includes Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage.
Detailed description
A randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group by stratified randomization according to participation of post-acute care. Patients in the intervention group will receive an 8-week web-based FRAIL-SM program. Data is collected by researchers using a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, and quality of life and physical indicators such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wed-based FRAIL-SM program | Experimental | Behavioral: web-based FRAIL-SM programPatients in the intervention group will receive an 8-week web-based FRAIL-SM program including family involvement, self-regulation, autonomy support, information sharing and linkage. |
| control group | No intervention | –Patients in this group will receive usual care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged above 20.
- Diagnosed with heart failure or LVEF<40%.
- Clear consciousness, can communicate with Chinese and Taiwanese.
- Consent to join in this study and have family partner.
- Access to computer or smartphone
Key exclusion criteria (9 listed)
- Bed-ridden or unable to perform activities of daily living independently.
- Diagnosed with cognitive, psychiatric disease, or major depression.
- Acute disease condition e.g. infection or thrombosis.
- Contraindications of performing exercise such as uncontrolled hypertension, uncontrolled arrhythmia.
- severe neurodegenerative or muscular diseases, e.g. parkinson's disease, arthritis.
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 |
|---|---|---|
| web-based FRAIL-SM programThe 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage. | Behavioural | wed-based FRAIL-SM program |
Primary outcome
Changes in Frailty Assessment Scale for Heart Failure scores
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Frailty Assessment Scale for Heart Failure scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Frailty Assessment Scale for Heart Failure contains 15 items, each item use Likert scale four point scoring (0-3), the total scores ranged from 0 to 45, the higher scores indicate higher levels of frailty.
Changes in Dutch Heart Failure Knowledge Scale scores
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Dutch Heart Failure Knowledge Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Dutch Heart Failure Knowledge Scale contains 15 items. The total scores ranged from 0 to 15, the higher scores indicate higher levels of knowledge.
Changes in Self-Care of Heart Failure Index scores
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Self-Care of Heart Failure Index scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Self-Care of Heart Failure Index contains 22 items, three subscales: self-care maintenance, self-care management, self-care confidence. Each subscale scores ranged from 0 to 100, the higher scores indicate higher levels of self-care maintenance, self-care management, self-care confidence.
Changes in Minnesota Living with Heart Failure questionnaire scores
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline Minnesota Living with Heart Failure questionnaire scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Minnesota Living with Heart Failure questionnaire contains 21 items, each item scores ranged from 0 to 5. The total socre ranged from 0 to 105, the higher scores indicate higher levels of impact on quality of life.
2 secondary outcomes
Changes in World Health Organization Quality of Life - BREF (WHOQOL-BREF) scale scores
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes in Caregiver Strain Index scores
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based FRAIL-SM program in people with Heart Failure, run by National Yang Ming Chiao Tung University 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 10 inclusion and 9 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: opening soon, as of the sponsor's last update on 25 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ai-Fu Chiou, PhD (886-2-28267354, afchiou@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Frailty Assessment Scale for Heart Failure scores (time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks). The study lists 4 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 25 Jul 2025.