INCLUDE Study – Inclusion and Equity in Acute Care / PROM Validation; Autonomy and safety in acute care of older adults - validation of the german version of the "patient-reported outcome measure for Older Patients receiving Acute Care" (PROM-OPAC)

INCLUDE Study – Inclusion and Equity in Acute Care / PROM Validation; Autonomy and safety in acute care of older adults - validation of the german version of the "patient-reported outcome measure for Older Patients receiving Acute Care" (PROM-OPAC) - INCLUDE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037988

Enrollment

320

Registered

2025-09-25

Start date

2025-11-04

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cultural adaptation and validation of PROM-OPAC

Interventions

Group 1: Emergency department patients aged 70 years and older Study Phase 1: Conducting cognitive interviews for the cultural validation of the German-language version of PROM-OPAC following emergenc

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Inclusion criteria

Inclusion criteria: German as a native language or proficiency in German at a near-native level (at least C1).

Exclusion criteria

Exclusion criteria: Medical reasons precluding participation (e.g., mechanical ventilation, resuscitation in the emergency room), insufficient proficiency in the survey language, lack of capacity to provide informed consent, or the presence of legal guardianship.

Design outcomes

Primary

Measure	Time frame
(1) the development of a culturally adapted German-language version of PROM-OPAC (WP 1), and (2) the validation of the final instrument, G-PROM-OPAC, in a cohort of older, frail patients (WP 2).	—

Secondary

Measure	Time frame
- Description of barriers to the collection of G-PROM-OPAC data in routine emergency care - Description of the sociodemographic, clinical, and care-related characteristics of the G-PROM-OPAC validation cohort - Description of discontinuation criteria for the collection of G-PROM-OPAC data - Description of reasons for non-participation in the respective work packages	—

Countries

Germany

Contacts

Public ContactAnna Slagman

Charité - Universitätsmedizin Berlin

anna.slagman@charite.de+49 30 450 531 142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026