FrailtyNCT06708494
Establishing Video Decision Aids for Geriatric Patients With Frailty to Promote Advance Care Planning
An observational study of Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- video decision aids
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Nov 2024to 31 Mar 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: National Taiwan University Hospital inpatient wards or the Department of Family Medicine's Geriatric Frailty Clinic.
Who may be able to join
- 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.
Show all 28Show fewer
- 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.
Who cannot join
- 1.Cognitive impairment, unable to communicate clearly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Frailty
- Being tested
- video decision aids
- Keywords
- Frailty, Advance Care Planning, Video Decision Aids
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video decision aidsBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Watching a 10-minute video and completing questionnaire takes approximately 5-10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start19 Nov 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708494
- Sponsor's protocol ID
- 202403006RIFC
- Status last verified
- Mar 2024
- First submitted
- 20 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Video Decision Aids for Geriatric Patients With Frailty to Promote Advance Care Planning: Comprehensibility, Usability, Feasibility
- ClinicalTrials.gov ID
- NCT06708494
- Acronym / sponsor ID
- 202403006RIFC
- Conditions
- Frailty
- Keywords
- Frailty, Advance Care Planning, Video Decision Aids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- National Taiwan University Hospital inpatient wards or the Department of Family Medicine's Geriatric Frailty Clinic.
Key inclusion criteria (28 listed)
- Phase 1 - Patients
- Phase 1 - Family Members
- Phase 1 - Healthcare Providers
- Phase 2 - Patients
- Phase 2 - Healthcare Providers
Key exclusion criteria (1 listed)
- 1.Cognitive impairment, unable to communicate clearly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video decision aidsThe 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. | Behavioural | – |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comprehensibility (time frame: Watching a 10-minute video and completing questionnaire takes approximately 5-10 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.