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NCT Number: NCT07068308

Effects 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Frailty Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients criteria:

Inclusion criteria

  • 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

Exclusion criteria

  • 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:

Inclusion criteria

  • 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

Exclusion criteria

  • Bed-ridden or unable to perform activities of daily living independently.
  • Diagnosed with cognitive, psychiatric disease, or major depression.
  • Have employment relationship with patients

Treatment and study plan

web-based FRAIL-SM program

Behavioral

The 8-week web-based FRAIL-SM includes family involvement, self-regulation, autonomy support, information sharing and linkage.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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 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.

  2. Changes in Caregiver Strain Index scores

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks and 24 weeks

    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.

Other outcomes

  1. Changes in Hospital Anxiety and Depression Scale scores

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

    Changes from baseline Hospital Anxiety and Depression Scale scores to at 4 weeks, 8 weeks, 12 weeks and 24 weeks after enrollment. The Hospital Anxiety and Depression Scale contains 14 items, two subscales: anxiety and depression. Each subscale scores ranged from 0 to 21, the higher scores indicate higher levels of anxiety and depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Ai-Fu Chiou, PhD

CONTACT

[email protected]

886-2-28267354

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Development and Effectiveness of a Wed-based FRAIL-SM Program Among Patients With Heart Failure

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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