Establishing Video Decision Aids for Geriatric Patients With Frailty to Promote Advance Care Planning

November 25, 2024 updated by: National Taiwan University Hospital

Establishing Video Decision Aids for Geriatric Patients With Frailty to Promote Advance Care Planning: Comprehensibility, Usability, Feasibility

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Phase 1 - Patients

    1. Aged 65 or older.
    2. Have not completed an advance directive (AD) document.
    3. Able to communicate in Mandarin or Taiwanese.
    4. Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
    5. Willing to participate in the study after explanation.
  • Phase 1 - Family Members

    1. Aged 18 or older.
    2. Have not completed an advance directive (AD) document.
    3. Able to communicate in Mandarin or Taiwanese.
    4. Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
    5. Willing to participate in the study after explanation.
  • Phase 1 - Healthcare Providers

    1. Have not completed an advance directive (AD) document.
    2. Able to communicate in Mandarin or Taiwanese.
    3. Willing to participate in the study after explanation.
  • Phase 2 - Patients

    1. Aged 65 or older.
    2. Have participated in shared decision-making (SDM) using decision aid tools.
    3. Have experience in advance care planning (ACP) consultation or have completed related written advance directive documents.
    4. Able to communicate in Mandarin or Taiwanese.
    5. Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
    6. Willing to participate in the study after explanation.
  • Phase 2 - Healthcare Providers

    1. Have professional knowledge and practical experience in advance care planning (ACP).
    2. Have experience caring for frail elderly populations.
    3. Able to communicate in Mandarin or Taiwanese.
    4. Willing to participate in the study after explanation.

Exclusion Criteria:

1.Cognitive impairment, unable to communicate clearly.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comprehensibility
Time Frame: Watching a 10-minute video and completing questionnaire takes approximately 5-10 minutes.

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202403006RIFC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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