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Completed

NCT Number: NCT03097146

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NeuroCure Clinical Research Center (NCRC), Charité

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comprehensive multidisciplinary stroke care

Other

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.

Primary outcomes

  1. "EuroQol five dimensions questionnaire" (EuroQoL-5D)

    Time frame: 12 Months

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

Secondary outcomes

  1. Post Stroke Checklist (PSC)

    Time frame: 12 Months

    checklist that helps identify post-stroke problems

  2. modified Rankin Scale (mRS)

    Time frame: 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)

    Time frame: 12 Months

    scale is used to measure performance in activities of daily living

  4. modified Ashworth Scale (mAS)

    Time frame: 12 Months

    scale is used as a measure of spasticity

  5. Pain Detect (PD-Q)

    Time frame: 12 Months

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

  6. Freiburg questionnaire for coping (FKV)

    Time frame: 12 Months

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

  7. Montreal Cognitive Assessment (MoCA)

    Time frame: 12 Months

    cognitive screening test in the detection of mild cognitive impairment

  8. partial Aachen Aphasia Test (AAT)

    Time frame: 12 Months

    test is used to diagnose and describe aphasic disturbances

  9. Hamilton rating scale for depression

    Time frame: 12 Months

    questionnaire is used to provide an indication of depression

  10. "Morisky Medication Adherence Scale" (MMAS)

    Time frame: 12 Months

    questionnaire is used to assess patients' medication-taking behaviour

  11. "Nikolaus score for evaluation of social conditions" (SoS)

    Time frame: 12 Months

    score is used to assess patients' social work intervention

  12. "Häusliche Pflegeskala" (HPS)

    Time frame: 12 Months

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

  13. Hospital Anxiety Depression Scale (HADS)

    Time frame: 12 Months

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 31, 2017
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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