Patient-Reported Outcome Measures (PROMs) on the Stroke Unit at the UKSH: An explorative mixed-method design of an implementation scientific pilot study (PROMImpact)

Patient-Reported Outcome Measures (PROMs) on the Stroke Unit at the UKSH: An explorative mixed-method design of an implementation scientific pilot study (PROMImpact) - PROMImpact

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036931

Enrollment

Registered

2025-05-20

Start date

2025-06-16

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

I64

Interventions

Group 1: With the help of the PROM measurement instruments PROMIS®-29 Profile v2.1 (PROMIS-29) and the short form 4a - Cognitive Functions (4-item short version on cognitive functions), medical and nu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: ischemic or hemorrhagic stroke event, treated in the Stroke Unit at the Lübeck Campus, UKSH.

Exclusion criteria

Exclusion criteria: Severe aphasia, insufficient cognitive ability to complete the questionnaire, lack of German language skills

Design outcomes

Primary

Measure	Time frame
The primary objective criterion of the quantitative study is feasibility as a typical target variable for the evaluation of implementation strategies. This describes the extent to which an evidence-based intervention (or implementation strategy) can be successfully used or implemented . The aim here is to evaluate the scope of implementation by documenting how many potentially eligible patients were asked to complete the PROMIS questionnaire and how many of those asked actually completed the questionnaires. The reasons given by patients for refusing to participate can also be recorded. This information is recorded on a separate document in the recruitment strategy. Secondary target variable: Under the target criterion of feasibility, implementation fidelity is also to be evaluated. This shows the extent to which missing values per item are conspicuous on the PROMIS questionnaire. Furthermore, descriptive analyses based on the PROMIS questionnaires and the socio-demographic data collected are intended to provide information on correlations between completed questionnaires and age or gender.	—

Measure

Time frame

The primary objective criterion of the quantitative study is feasibility as a typical target variable for the evaluation of implementation strategies. This describes the extent to which an evidence-based intervention (or implementation strategy) can be successfully used or implemented . The aim here is to evaluate the scope of implementation by documenting how many potentially eligible patients were asked to complete the PROMIS questionnaire and how many of those asked actually completed the questionnaires. The reasons given by patients for refusing to participate can also be recorded. This information is recorded on a separate document in the recruitment strategy. Secondary target variable: Under the target criterion of feasibility, implementation fidelity is also to be evaluated. This shows the extent to which missing values per item are conspicuous on the PROMIS questionnaire. Furthermore, descriptive analyses based on the PROMIS questionnaires and the socio-demographic data collected are intended to provide information on correlations between completed questionnaires and age or gender.

—

Secondary

Measure	Time frame
Target criteria of the qualitative analyses: The quantitative data collection will be supplemented by conducting qualitative guideline-based interviews with the medical and nursing staff of the stroke unit. The focus here is on components such as feasibility, manageability, integration of PROMIS into everyday care and staff satisfaction.	—

Countries

Germany

Contacts

Public ContactKatja Götz

Institut für Allgemeinmedizin

katja.goetz@uni-luebeck.de0451-3101-8010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026