NCT06708494

Brief Summary

The goal of this observational study aimed to develop and assess a video decision aid for advance care planning in geriatric patients with frailty. The main question it aims to answer is: The video decision aid comprehensibility, usability, feasibility? The video includes an introduction to geriatric frailty (3 minutes) and advance care planning (5 minutes). Advance care planning includes three levels of medical care: life-prolonging care, limited care, and comfort care.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 27, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

November 20, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

FrailtyAdvance Care PlanningVideo Decision Aids

Outcome Measures

Primary Outcomes (3)

  • comprehensibility

    Comprehensibility was measured using a knowledge questionnaire and the Patient Education Materials Assessment Tool for Audiovisual Materials (PEMAT-A/V).The knowledge questionnaire consists of 7 questions, each with 10 correct answer choices, scored at 10 points per correct choice, for a total of 100 points. Higher scores indicate greater accuracy in knowledge and better comprehension. The PEMAT-A/V evaluates comprehension through 13 items and feasibility through 4 items. Responses are scored as Agree = 1 point, Disagree = 0 points, and Not Applicable (N/A) excluded from the total score calculation. The final score is calculated as Total Points/Total Possible Points x 100. Higher scores indicate that the material is easier to comprehend or more feasibility. Measurement timing: elder patients and their family members will complete the knowledge questionnaire before viewing the video. They will also complete the PEMAT A/V within one hour after viewing the materials.

    Watching a 10-minute video and completing questionnaire takes approximately 5-10 minutes.

  • usability

    Usability was evaluated through a feedback questionnaire. The feedback questionnaire consists of 6 items. Except for the final open-ended question, the remaining items are scored using a 4-point Likert scale (0-3). Lower scores indicate higher usability. Measurement timing: elder patients and their family members will complete the feedback questionnaire within one hour after viewing the materials.

    Watching a 10-minute video and completing questionnaire takes approximately 5-10 minute

  • feasibility

    Feasibility were evaluated through the PEMAT-A/V. The PEMAT-A/V evaluates comprehension through 13 items and feasibility through 4 items. Responses are scored as Agree = 1 point, Disagree = 0 points, and Not Applicable (N/A) excluded from the total score calculation. The final score is calculated as Total Points/Total Possible Points x 100. Higher scores indicate that the material is easier to comprehend or more feasibility. Measurement timing: elder patients and Healthcare professionals (Have experience in advance care planning) will complete the PEMAT A/V within one hour after viewing the materials.

    Watching a 10-minute video and completing questionnaire takes approximately 5-10 minute

Interventions

The video includes an introduction to geriatric frailty (3 minutes) and ACP (5 minutes). ACP includes three levels of medical care: life-prolonging care, limited care, and comfort care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

National Taiwan University Hospital inpatient wards or the Department of Family Medicine's Geriatric Frailty Clinic.

You may qualify if:

  • Phase 1 - Patients
  • Aged 65 or older.
  • Have not completed an advance directive (AD) document.
  • Able to communicate in Mandarin or Taiwanese.
  • Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
  • Willing to participate in the study after explanation.
  • Phase 1 - Family Members
  • Aged 18 or older.
  • Have not completed an advance directive (AD) document.
  • Able to communicate in Mandarin or Taiwanese.
  • Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
  • Willing to participate in the study after explanation.
  • Phase 1 - Healthcare Providers
  • Have not completed an advance directive (AD) document.
  • Able to communicate in Mandarin or Taiwanese.
  • +13 more criteria

You may not qualify if:

  • Cognitive impairment, unable to communicate clearly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 27, 2024

Study Start

November 19, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

November 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations