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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT03097146
• Collaborator: Center for Stroke Research Berlin (Other), Hebrew University of Jerusalem (Other), NeuroCure Clinical Research Center, Charite, Berlin (Other)
• Enrollment: 61
• Location: 1
• Arm: 1
• Actual Duration (Months): 46.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: comprehensive multidisciplinary stroke care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
• Actual Study Start Date: Apr 11, 2017
• Actual Primary Completion Date: Dec 22, 2020
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. "EuroQol five dimensions questionnaire" (EuroQoL-5D) [12 Months]

   questionnaire for self-completion by patients for use as a measure of health outcome

Secondary Outcome Measures

1. Post Stroke Checklist (PSC) [12 Months]

   checklist that helps identify post-stroke problems

2. modified Rankin Scale (mRS) [12 Months]

   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

3. Barthel-Index (BI) [12 Months]

   scale is used to measure performance in activities of daily living

4. modified Ashworth Scale (mAS) [12 Months]

   scale is used as a measure of spasticity

5. Pain Detect (PD-Q) [12 Months]

   questionnaire for self-completion by patients for the identification of neuropathic pain

6. Freiburg questionnaire for coping (FKV) [12 Months]

   questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior

7. Montreal Cognitive Assessment (MoCA) [12 Months]

   cognitive screening test in the detection of mild cognitive impairment

8. partial Aachen Aphasia Test (AAT) [12 Months]

   test is used to diagnose and describe aphasic disturbances

9. Hamilton rating scale for depression [12 Months]

   questionnaire is used to provide an indication of depression

10. "Morisky Medication Adherence Scale" (MMAS) [12 Months]

    questionnaire is used to assess patients' medication-taking behaviour

11. "Nikolaus score for evaluation of social conditions" (SoS) [12 Months]

    score is used to assess patients' social work intervention

12. "Häusliche Pflegeskala" (HPS) [12 Months]

    questionnaire is used to assess social work Intervention and couple's counselling

13. Hospital Anxiety Depression Scale (HADS) [12 Months]

    questionnaire for self-completion by patients to determine the levels of anxiety and depression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NeuroCure Clinical Research Center (NCRC), Charité	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany
• Center for Stroke Research Berlin
• Hebrew University of Jerusalem
• NeuroCure Clinical Research Center, Charite, Berlin

Investigators

• Principal Investigator: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03097146
• Other Study ID Numbers: MAS-II
• First Posted: Mar 31, 2017
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany: Stroke; Aftercare; Comprehensive Care
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Mar 25, 2022