Patient Reported Outcomes in Stroke Care

NCT03795948 | Completed

• 1 other identifier: 0977_114
• Study Type: interventional
• Target: 975
• Locations: 1 country
• Sites: 1

Brief Summary

The presented study is an explorative prospective study. First, it focusses on the longitudinal analysis of outcome quality in stroke treatment (12 months). Particularly, it addresses patient reported quality of life after inpatient stroke treatment and influencing factors. Second, it focusses on the feasibility and acceptance of a standard set of measures capturing outcome quality of medical care in stroke patients.

Conditions

Stroke

Keywords

Stoke; Patient-reported outcomes (PROs); Quality of life; Morbidity; Mortality; Functional status; Patient-centered care; ICHOM; Treatment quality

Outcome Measures

Primary Outcomes (1)

• Global patient reported health-related quality of life

  PROMIS-10

  90 days

Secondary Outcomes (7)

• Patient reported mental health status

  90 days

• Recurrence of disease

  90 days

• Acute complications of treatment

  at discharge from inpatient care, on average 6 days after admission

• Use of healthcare services after stroke

  90 days

• Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care

  after study completion (2 years)

Study Arms (1)

PROM Evaluation for stroke patients

OTHER

Patient will be enrolled and PROMs will be collected.

Other: PROMs

Interventions

PROMs OTHER

Introduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke. Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life. Telephone assessments will be administered to support patients if necessary and validate their responses.

PROM Evaluation for stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in inpatient care in the stroke unit of the UKE with the following diagnoses (ICD-10):
• Ischemic attack (I63),
• Transient ischemic attack (G45)
• Intracerebral hemorrhage (I64)
• Written informed consent

You may not qualify if:

• Substantially impaired communication capacity due to aphasia or dementia

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

Related Publications (5)

• Rimmele DL, Petersen EL, Schrage T, Harter M, Kriston L, Thomalla G. Self-reported health status of patients with acute retinal ischemia and stroke related hemianopia. Eur Stroke J. 2025 Sep;10(3):837-843. doi: 10.1177/23969873251314715. Epub 2025 Jan 25.

  PMID: 39862068 DERIVED

• Lebherz L, Fraune E, Thomalla G, Frese M, Appelbohm H, Rimmele DL, Harter M, Kriston L. Implementability of collecting patient-reported outcome data in stroke unit care - a qualitative study. BMC Health Serv Res. 2022 Mar 16;22(1):346. doi: 10.1186/s12913-022-07722-y.

  PMID: 35292028 DERIVED

• Rimmele DL, Schrage T, Lebherz L, Kriston L, Gerloff C, Harter M, Thomalla G. Profiles of patients' self-reported health after acute stroke. Neurol Res Pract. 2021 Aug 23;3(1):43. doi: 10.1186/s42466-021-00146-9.

  PMID: 34420516 DERIVED

• Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study. Neurol Res Pract. 2019 Nov 1;1:28. doi: 10.1186/s42466-019-0034-0. eCollection 2019.

  PMID: 33324894 DERIVED

• Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Health-related quality of life 90 days after stroke assessed by the International Consortium for Health Outcome Measurement standard set. Eur J Neurol. 2020 Dec;27(12):2508-2516. doi: 10.1111/ene.14479. Epub 2020 Sep 7.

  PMID: 32810906 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomalla Götz, MD, Prof.

  Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 8, 2019
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

DE (1)