NCT06671353

Brief Summary

As the proportion of the aging population continues to rise, age-related frailty syndrome, characterized by a decline in the function of multiple physiological systems and accompanied by vulnerability to stress, has become a significant issue. It has been associated with higher mortality rates, hospitalization rates, risk of falls, occurrence of fractures, decreased mobility, depression, cognitive decline, dementia, loneliness, and admission to long-term care facilities. Advance care planning is a thoughtful and communicative process that helps individuals, while still cognitively capable, to pre-determine and express their preferences for medical care in the event of future incapacity. With the ongoing development in the field of frailty and the rapid aging of the population, the increasing age may be accompanied by severe illnesses, symptom burden, functional dependence, caregiver burden, and extensive medical utilization. The importance of advance care planning is increasingly emphasized, but its implementation and promotion remain challenging. In addition to systematic promotion from a policy perspective, tools to assist patients in decision-making have been proposed. Video decision aids can encourage people to engage in advance care planning by sparking conversations about informed consent and helping individuals contemplate the choices they may face. Video decision aids can also assist individuals in envisioning future scenarios and reflecting on their decisions. Previous randomized controlled trials have explored the benefits of such video tools for specific patient populations, such as cancer patients, heart failure patients, and elderly individuals hospitalized. However, there is a need for innovative approaches to enhance the knowledge, willingness, and actual signing rates of advance care planning for frail elderly individuals. This study aims to develop a video decision aid specifically tailored for the elderly frail population undergoing advance care planning. Through a randomized controlled trial, the study aims to validate its actual benefits, expecting to assist the elderly frail population in understanding and expressing their willingness for advance care planning, increasing the actual willingness to sign advance directives, and helping clinical healthcare teams achieve person-centered, high-quality care for this population.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Dec 2027

First Submitted

Initial submission to the registry

October 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

November 19, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

October 28, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

frailtyadvance care planningshared decision making

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients completed advance decision

    The advance decision must be completed by the patients and uploaded to the National Health insurance system

    from enrollment to 4 weeks after watching video decision aid

Study Arms (2)

control

NO INTERVENTION

with video decision aid

ACTIVE COMPARATOR

video decision aid

Behavioral: video decision aid

Interventions

video decision aid for advance care planning

with video decision aid

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age \> or = 65 y/o can communicate and sign informed consent diagnosed to be frailty with clinical frailty scale 4-7

You may not qualify if:

  • impaired visual acuity or hearing that can't watch video had signed advance decision before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Research Ethics Committee

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • Thompson JS, Matlock DD, McIlvennan CK, Jenkins AR, Allen LA. Development of a Decision Aid for Patients With Advanced Heart Failure Considering a Destination Therapy Left Ventricular Assist Device. JACC Heart Fail. 2015 Dec;3(12):965-76. doi: 10.1016/j.jchf.2015.09.007.

    PMID: 26671675BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hsien-Liang Solomon Huang, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

November 4, 2024

Study Start

November 19, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

the data will include personal data

Locations