- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06708494
Establishing Video Decision Aids for Geriatric Patients With Frailty to Promote Advance Care Planning
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
- Willing to participate in the study after explanation.
Phase 2 - Patients
- Aged 65 or older.
- Have participated in shared decision-making (SDM) using decision aid tools.
- Have experience in advance care planning (ACP) consultation or have completed related written advance directive documents.
- 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 2 - Healthcare Providers
- Have professional knowledge and practical experience in advance care planning (ACP).
- Have experience caring for frail elderly populations.
- Able to communicate in Mandarin or Taiwanese.
- Willing to participate in the study after explanation.
Exclusion Criteria:
1.Cognitive impairment, unable to communicate clearly.
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
McMaster UniversityRecruitingFrailty | Frailty Syndrome | Frail Older Adults | Frailty in AgingCanada
-
University of IcelandLandspitali University HospitalRecruitingFrailty Syndrome | Elective Surgery | Frailty in Adult SurgeryIceland
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Universidad Francisco de VitoriaActive, not recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric HealthSpain
-
Ji Yan Biomedical Co., Ltd.YC Biotech Co., Ltd.Not yet recruiting
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
University of NottinghamRecruitingFrailty | Diet | Systemic Inflammatory Response | Dietary Fiber | Frailty at Older Adults | Pre-FrailtyUnited Kingdom
-
National Taipei University of Nursing and Health...Not yet recruiting
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
Clinical Trials on video decision aids
-
Dartmouth-Hitchcock Medical CenterCompleted
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Taipei Medical University Shuang Ho HospitalUnknown
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Shenzhen Maternity & Child Healthcare HospitalRecruitingLeiomyoma, Uterine | High-Intensity Focused Ultrasound Ablation | Patients Decision AidsChina
-
University of AarhusTrygFonden, DenmarkCompletedCardiovascular Disease | High Cholesterol
-
University of Colorado, DenverNational Institute on Aging (NIA)CompletedHospice | Hospice Decision Making | End-of-life Decision MakingUnited States
-
SingHealth PolyclinicsCompletedHypothyroidismSingapore
-
Massachusetts General HospitalFoundation for Informed Medical Decision MakingCompleted
-
Massachusetts General HospitalCompletedCoronary Artery Disease | Stable AnginaUnited States