Interactive Patient Education App for Informed Consent Before Cataract Surgery
NCT07931976, Not applicable, Completed, Johannes Kepler University of Linz
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Interactive Patient Education App for Informed Consent Before Cataract Surgery | ClinicalTrials.gov |
| NCT number | NCT07931976 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Johannes Kepler University of Linz | ClinicalTrials.gov |
| Conditions | Cataract, Informed Consent | ClinicalTrials.gov |
| Interventions | PAULA interactive patient education app, General control video | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective Knowledge About Cataract Surgery | immediately after the preoperative informed consent discussion | Score on a 20-item single-choice questionnaire assessing knowledge about cataract, cataract surgery, risks and postoperative course. Score range 0-20 (number of correct answers); higher scores indicate better knowledge. | ClinicalTrials.gov |
| Secondary | Duration of the Physician's Informed Consent Discussion | immediately after the preoperative informed consent discussion | Duration of the face-to-face informed consent discussion between physician and participant, measured in minutes. | ClinicalTrials.gov |
| Secondary | Decisional Conflict Scale (DCS) Total Score | immediately after the preoperative informed consent discussion | Total score of the Decisional Conflict Scale (16 items). Score range 0-100; higher scores indicate greater decisional conflict. | ClinicalTrials.gov |
| Secondary | Vision-Related Quality of Life (Catquest-9SF, German Version) | immediately after the preoperative informed consent discussion | Patient-reported visual function measured with the German version of the 9-item Catquest-9SF questionnaire, analyzed as Rasch-calibrated person score; lower scores indicate fewer difficulties with vision in daily life. | ClinicalTrials.gov |
| Secondary | Usability of the PAULA App (System Usability Scale) | immediately after the preoperative informed consent discussion | System Usability Scale (SUS), 10 items, assessed in the intervention group only. Score range 0-100; higher scores indicate better usability. | ClinicalTrials.gov |
| Other | Workflow Efficiency as Rated by Clinical Staff | immediately after the preoperative informed consent discussion | Individual assessments of clinical staff regarding the efficiency of the preoperative consent workflow. | ClinicalTrials.gov |
| Other | Acceptance of the App and Difficulties Using the Tablet | immediately after the preoperative informed consent discussion | Acceptance of the app and difficulties in handling the tablet, documented in written notes by clinical assistant staff. | ClinicalTrials.gov |
| Other | Qualitative Participant Feedback | immediately after the preoperative informed consent discussion | Oral qualitative feedback from participants on the informed consent process. | 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 |
|---|
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 |
|---|
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 |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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)