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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097146
• Other study ID #: MAS-II
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 1, 2021
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	NeuroCure Clinical Research Center (NCRC), Charité	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Center for Stroke Research Berlin, Hebrew University of Jerusalem, NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"EuroQol five dimensions questionnaire" (EuroQoL-5D)	questionnaire for self-completion by patients for use as a measure of health outcome	12 Months
Secondary	Post Stroke Checklist (PSC)	checklist that helps identify post-stroke problems	12 Months
Secondary	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
Secondary	Barthel-Index (BI)	scale is used to measure performance in activities of daily living	12 Months
Secondary	modified Ashworth Scale (mAS)	scale is used as a measure of spasticity	12 Months
Secondary	Pain Detect (PD-Q)	questionnaire for self-completion by patients for the identification of neuropathic pain	12 Months
Secondary	Freiburg questionnaire for coping (FKV)	questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior	12 Months
Secondary	Montreal Cognitive Assessment (MoCA)	cognitive screening test in the detection of mild cognitive impairment	12 Months
Secondary	partial Aachen Aphasia Test (AAT)	test is used to diagnose and describe aphasic disturbances	12 Months
Secondary	Hamilton rating scale for depression	questionnaire is used to provide an indication of depression	12 Months
Secondary	"Morisky Medication Adherence Scale" (MMAS)	questionnaire is used to assess patients' medication-taking behaviour	12 Months
Secondary	"Nikolaus score for evaluation of social conditions" (SoS)	score is used to assess patients' social work intervention	12 Months
Secondary	"Häusliche Pflegeskala" (HPS)	questionnaire is used to assess social work Intervention and couple's counselling	12 Months
Secondary	Hospital Anxiety Depression Scale (HADS)	questionnaire for self-completion by patients to determine the levels of anxiety and depression	12 Months