Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients

After discharge from hospital, the current healthcare system in Germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. The investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. In this study, the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: comprehensive multidisciplinary stroke care

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • NeuroCure Clinical Research Center (NCRC), Charité

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with ischemic stroke
• Age ≥18 years
• At the time of V1 completion of rehabilitation or no rehabilitation planned
• Informed consent signed by patient or legal representative
• stroke patients with a stratified mRS score
• within six months after the index event

Exclusion Criteria:

• Unwillingness to participate in "AmbulanzPartner"
• Unwilling to have pseudonymized data stored, analysed, and anonymously published
• Patients being committed to psychiatric institutions or prisons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: comprehensive multidisciplinary stroke care

Other: comprehensive multidisciplinary stroke care; Patients will be treated in the pathological domain. Some of this treatment will be applied by the outpatient clinic itself (i.e. changes in medical secondary prevention or additional prescriptions, social work interventions), whereas most of it will be referred to other providers, if possible in vicinity to the patients' home. In order to ease treatment prescriptions and allow to measure treatment uptake, patients will also enrol in the case management system "Ambulanzpartner". This allows the outpatient center to streamline prescription processes and measure uptake of therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"EuroQol five dimensions questionnaire" (EuroQoL-5D)	questionnaire for self-completion by patients for use as a measure of health outcome	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Stroke Checklist (PSC)	checklist that helps identify post-stroke problems	12 Months
modified Rankin Scale (mRS)	scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability	12 Months
Barthel-Index (BI)	scale is used to measure performance in activities of daily living	12 Months
modified Ashworth Scale (mAS)	scale is used as a measure of spasticity	12 Months
Pain Detect (PD-Q)	questionnaire for self-completion by patients for the identification of neuropathic pain	12 Months
Freiburg questionnaire for coping (FKV)	questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior	12 Months
Montreal Cognitive Assessment (MoCA)	cognitive screening test in the detection of mild cognitive impairment	12 Months
partial Aachen Aphasia Test (AAT)	test is used to diagnose and describe aphasic disturbances	12 Months
Hamilton rating scale for depression	questionnaire is used to provide an indication of depression	12 Months
"Morisky Medication Adherence Scale" (MMAS)	questionnaire is used to assess patients' medication-taking behaviour	12 Months
"Nikolaus score for evaluation of social conditions" (SoS)	score is used to assess patients' social work intervention	12 Months
"Häusliche Pflegeskala" (HPS)	questionnaire is used to assess social work Intervention and couple's counselling	12 Months
Hospital Anxiety Depression Scale (HADS)	questionnaire for self-completion by patients to determine the levels of anxiety and depression	12 Months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: NeuroCure Clinical Research Center, Charite, Berlin; Hebrew University of Jerusalem; Center for Stroke Research Berlin

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ACTUAL): December 22, 2020
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (ACTUAL): March 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Aftercare; Comprehensive Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MAS-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No