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FrailtyFRAIL-SMNCT05765721

Family-based Frailty Self Management Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure

A study testing FRAIL-SM Program in people with Frailty and Quality of Life, run by National Yang Ming Chiao Tung University at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial study aims to develop a frailty self-management model for heart failure patients, and to examine the effect of family-based frailty self-management program (FRAIL-SM) including Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage on frailty, knowledge… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Frailty, Quality of Life, Self-management
What is being tested?
FRAIL-SM Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
2 sitesTaiwan
Study dates
16 Nov 2023to 1 Oct 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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Patients Inclusion Criteria:

  1. aged ≥ 40 years.
  2. diagnosed by doctros with heart failure and in stable condition.
  3. clear consciousness, can communicate with Chinese and Taiwanese.
  4. consent to join in this study.
  5. have a smartphone or computer and be able to join social media
  6. have SOF score ≥ 1

Patients Exclusion Criteria:

  1. were bed-ridden or unable to perform activities of daily living independently.
  2. diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
  3. in the acute stage of the disease, such as inflammation, infection, or vascular embolism
  4. with contraindications to exercise, such as those with uncontrolled arrhythmia, unstable heart rate, BP or PaO2.
  5. suffer from neurological, muscular, skeletal or rheumatoid diseases that are aggravated by exercise.

Caregivers Inclusion Criteria:

  1. aged ≥ 20 years.
  2. clear consciousness, can communicate with Chinese and Taiwanese.
  3. consent to join in this study with patients.

Caregivers Exclusion Criteria:

  1. have serious chronic diseases and need to dependent on others for daily living
  2. diagnosed by doctors with cognitive dysfunction, mental illness, or severe depression
  3. have an employment relationship with the patient

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Development of Family-based Frailty Selfmanagement Model and the Effects of the FRAIL-SM Program Among Patients With Heart Failure

This randomized controlled trial study aims to develop a frailty self-management model for heart failure patients, and to examine the effect of family-based frailty self-management program (FRAIL-SM) including Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage on frailty, knowledge, self-care ability and quality of life in patients with heart failure and their family's strain, knowledge, confedence, and quality of life. Data is collected by a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, anxiety and depression, social support, and quality of life and physical indicators at baseline, 4 weeks, 8 weeks and 12 weeks after enrollment.

Read the detailed description

This study aims to develop a frailty self-management model for heart failure patients, and to examine the effect of family-based frailty self-management program (FRAIL-SM) including Family involvement, self-Regulation, Autonomy support, Information sharing and Linkage on frailty, self-care ability and quality of life in patients with heart failure and their family's strain and quality of life. Patients are recruited with a convenience sampling from two medical centers in Taiwan.

A cross-sectional study is adopted to examine the associated factors of frailty and self-management in patients with heart failure. Besides, a qualitative research with face-to-face individual interview is conducted to understand the experience of frailty and self-management in patients with heart failure and their families. Then, a randomized controlled trial is conducted. Subjects are selected using a convenience sampling and are randomly assigned to the intervention or control group. Patients in the intervention group will receive an 8-week family-based frailty self-management program. Data is collected by a structural questionnaire including frailty, heart failure knowledge, self-care of heart failure, anxiety and depression, social support, and quality of life and physical indicators such as levels of B-type natriuretic peptide, hemoglobin, hematocrit, albumin at baseline, 4 weeks, 8 weeks and 12 weeks after enrollment. Data analysis includes descriptive statistics, Pearson correlation coefficient, independent t-test, chi-square, one-way ANOVA, multiple regression, structural equation modeling, and generalized estimating equation.

Being tested
FRAIL-SM Program
Keywords
Frailty, Quality of Life, self management, Heart failure, family-based program
Medical subject headings
Frailty, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FRAIL-SM ProgramBehavioural

    Patients in experimental group will receive a 8 week family-based frailty self-management program; patients in control group maintain their usual life activities.

Study groups in NCT05765721
Study groupRoleWhat they receive
intervention groupExperimentalPatients in this group will receive a 8-week family-based frailty self-management program including: (1) one 20-30 minute individual consultation (teaching how to join the family-based frailty self-management program by using poster); (2) provided self-management booklet; (3) provided family-based frailty self-management program video through Line group meeting, once per two weeks ; (4) individual consultation through telephone follow-up once per week for 8 weeks
Receives: Behavioral: FRAIL-SM Program
Control groupNo interventionPatients in this group maintain their daily life activities, and there is no intervention given.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Frailty Assessment Scale for Heart Failure( FAS-HF) scores

    Changes from baseline Frailty Assessment Scale for Heart Failure (FAS-HF) scores including three indicators: physical, Psychological and social , at 4 weeks, 8 weeks, 12 weeks. FAS-HF scale contains 15 items, each item use Likert scale five point scoring, the total scores ranged from 0 to 45,the higher scores indicate higher frailty.

    Measured: baseline, 4week, 8week, 12week

  2. Changes in The Minnesota living with heart failure questionnaire(MLHFQ) scores

    Changes from baseline Minnesota living with heart failure questionnaire at 4 weeks, 8 weeks, 12 weeks. The Minnesota living with heart failure questionnaire contains 21 questions regarding the effects of heart failure on patients' physical (eight questions),emotional (five questions) and general (eight questions) dimensions. The possible answer for each question ranges from 0(no) to 5(a lot), and the total score range is 0-105; a higher score indicates lower quality of life .

    Measured: baseline, 4week, 8week, 12week

  3. Changes in the Self-Care of Heart Failure Index scores

    Changes from baseline Self-Care of Heart Failure Index scores including three indicators: self-maintenance, self-management and self confidence , at 4 weeks, 8 weeks, 12 weeks. This scale contains 22 items, each item use Likert scale four point scoring, the total scores ranged from 22 to 88, the higher scores indicate better self-care.

    Measured: baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (6)

  1. Changes in symptoms distress scores

    Changes from baseline symptoms distress scores at 4 weeks, 8 weeks, 12 weeks. Symptoms distress scale contains 17 common symptoms items, each item use Likert scale five point scoring, the total scores ranged from 17 to 85, the higher scores indicate worse symptom distress

    Measured: baseline, 4week, 8week, 12week

  2. Changes in anxiety and depression scores

    Changes from baseline hospital anxiety and depression scale at 4 weeks, 8 weeks, 12 weeks. The hospital anxiety and depression scale contains 14 questions(7 for assess anxiety and 7 for assess depression), each item use Likert scale four point scoring, the total scores ranged from 0 to 21, the higher scores indicate more severe anxiety and depression level.

    Measured: baseline, 4week, 8week, 12week

  3. Changes in caregivers confidence of heart failure self care

    Changes in the Self-Care of Heart Failure Index (SCHFI) scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The SCHFI is a self-report measure comprised of 15 items rated on a 4-point response scale and divided into 3 subscales: self-care maintenance, self-care management, and self-care confidence. Self-care maintenance consists of 5 items assessing adherance to HF self care recommendations. Self-care management consists of 6 items assessing the ability to recognize and deal with HF symptoms. Self-care confidence consists of 4 items assessing the confidence in control and manage HF symptoms.

    Measured: baseline, 4week, 8week, 12week

  4. Changes in The Caregiver Strain Index(CSI)

    Changes in the Caregiver Strain Index(CSI) scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The CSI is a 13-item objective questionaire designed to assess level of stress experienced by the informal caregivers.

    Measured: baseline, 4week, 8week, 12week

  5. Changes in heart failure knowledge of caregivers

    Changes in Dutch Heart Failure Knowledge Scale (DHFKS) scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The DHFKS consists of 15 items assessing HF knowledge: 4 items regarding general HF information, 6 items regarding HF treatment (diet, fluid restrictions and activity) and 5 items assessing symptoms and symptom recognition.

    Measured: baseline, 4week, 8week, 12week

  6. Changes in caregivers' quality of life

    Changes in the WHO Quality of Life-Brief(WHOQOL-BREF) Taiwan version scores of caregivers from baseline to 4weeks, 8weeks, and12 weeks. The WHOQOL-BREF Taiwan version is a 28-item questionaire rated on a 5-point response scale. It divides quality of life into 4 domains: physical health, psychological, social relationships and environment.

    Measured: baseline, 4week, 8week, 12week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start16 Nov 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

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
Patients in the intervention group will receive an 8-week family-based frailty self-management program including:individual consultation, teaching how to do self-management by family-based frailty self-management video.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05765721
Sponsor's protocol ID
YM111045EF
Acronym
FRAIL-SM
Status last verified
Mar 2025
First submitted
1 Mar 2023
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FRAIL-SM Program in people with Frailty and Quality of Life, run by National Yang Ming Chiao Tung University at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 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 2 sites 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 Frailty Assessment Scale for Heart Failure( FAS-HF) scores (time frame: baseline, 4week, 8week, 12week). 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?

On the ClinicalTrials.gov record for NCT05765721.

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 10 Jul 2025.

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