Animated Versus Paper-Based Patient Decision Aids for Tracheostomy: Effects on Family Caregivers' Knowledge and Preparation for Decision Making
NCT07923955, Not applicable, Not yet recruiting, National Taiwan University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Animated Versus Paper-Based Patient Decision Aids for Tracheostomy: Effects on Family Caregivers' Knowledge and Preparation for Decision Making | ClinicalTrials.gov |
| NCT number | NCT07923955 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 178 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National Taiwan University Hospital | ClinicalTrials.gov |
| Conditions | Tracheostomy Patients, Decision Making ,Shared, Prolonged Mechanical Ventilation | ClinicalTrials.gov |
| Interventions | Animated tracheostomy patient decision aid, Paper-based tracheostomy patient decision aid | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Tracheostomy Knowledge Score | Baseline (before randomization) and immediately after the decision-aid session (Day 1, same study visit) | Measured with an investigator-developed 10-item true/false tracheostomy knowledge test. Items 1-4 address common misconceptions (reverse-keyed) and items 5-10 address correct facts. Each correct answer scores 1 point; total score range 0-10, with higher scores indicating greater knowledge. The between-group difference in the post-intervention score will be estimated by ANCOVA adjusted for the baseline score. | ClinicalTrials.gov |
| Secondary | Preparation for Decision Making (PrepDM) Scale Score | Immediately after the decision-aid session | 10-item PrepDM scale (Chinese version) assessing how useful the decision aid was in preparing the respondent to communicate with clinicians and make the decision. Each item is rated from 1 (not at all) to 5 (a great deal). The mean item score (1-5) is converted to a 0-100 scale as (mean - 1) x 25; higher scores indicate greater perceived preparation for decision making. | ClinicalTrials.gov |
| Secondary | Values Clarification Scale Score | Immediately after the decision-aid session | Investigator-developed 7-item scale. Each item presents a pair of contrasting considerations about tracheostomy versus continued endotracheal intubation (eating and speaking, going home, body integrity and stoma, tube fixation, infection risk, mouth closure, and type of pain), rated from 1 (leaning toward maintaining intubation) to 10 (leaning toward tracheostomy). Total score range 7-70; higher scores indicate values leaning toward tracheostomy. There is no better or worse direction. Total scores will be compared between groups, and item-level distributions will be reported descriptively. | ClinicalTrials.gov |
| Secondary | Change in Self-Rated Anxiety (Retrospective Pre-Post Rating) | Immediately after the decision-aid session | Two investigator-developed items completed after the decision-aid session ask participants to rate their anxiety about the patient's current medical situation before and after the intervention, each from 1 (not at all) to 5 (a great deal). Change score = after minus before (range -4 to +4); negative values indicate reduced anxiety. This is a non-validated, supplementary descriptive measure. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)