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StrokeNCT02793934

The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation

An observational study of Stroke and AMI, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions: 1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology) 2. Acute myocardial infarction (AMI, specialty cardiology) 3. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, AMI, Total Hip Replacement
What is being tested?
Scales, New model of rehabilitation and Old model of rehabilitation
How many people
2,000 participants
Where
1 siteRussia
Study dates
Sep 2015to Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions: Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology) Acute myocardial infarction (AMI, specialty cardiology) Patients after total hip replacement (THR, specialty orthopaedia)

Who may be able to join

  • Age over 18 years old
  • Ischemic stroke or intracerebral hemorrhage
  • Patients with acute myocardial infarction with elevation of segment ST (STMI)
  • Total hip replacement caused by degenerative processes

Who cannot join

  • uncorrected metabolic diseases (diabetes mellitus, myxoedema, thyrotoxicosis);
  • III hepatic or pancreatic insufficiency
  • heavy or repeated hemorrhages of any reason or anaemia Hb<80g/l;
  • parasitoses;
  • acute infectious disease;
  • active stage of any form of tuberculosis;
Show all 12Show fewer
  • patients with transmissible sexual diseases;
  • mental illness with personality desocialisation;
  • complicate ventricular rhythm disturbances
  • high risk of thromboembolism
  • absence of motivation
  • decompensation of somatic functions

Trial locations and contacts

1 site in 1 country.

Ivanova Galina, Professor contact

+79161144504

reabiivanova@mail.ru

Melnikova Elena, Professor contact

+7 (911) 743-15-08

melnikovae2002@mail.ru

Russia1 site, 1 recruiting
  • StPetersburgSPMU

    Saint Petersburg, 197022

    Elena V. Melnikova, MD, Ph.D, +7117431508, melnikovae2002@gmail.com

    Alexey A. Shmonin, Ph.D, +79213568136, langendorff@gmail.com

    Recruiting

Other trials in Russia

About this study

Official title: The Development Of MEdical Rehabilitation inRussia Pilot Project

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

  1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
  2. Acute myocardial infarction (AMI, specialty cardiology)
  3. Patients after total hip replacement (THR, specialty orthopaedia) The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).
Read the detailed description

The program is performed in the in-patient and out-patient rehabilitation departments in 13 regions of the Russian Federation (total 244 departments).

The basic goals of the Programme are:

  1. To develop the system of organizations for medical rehabilitation providing succession of rehabilitation care in Russia with covering all needs.
  2. To improve the accessibility for rehabilitation care by the system of successive 3-stages and 3-level medical rehabilitation
  3. To develop the multidisciplinary approaches on medical rehabilitation in each stages and in medical organizations of different levels
  4. To improve patient's daily living activity, functioning, enable participation, reduce sick-leaves duration and working absenteeism, increase social role in community, prevent pain recurrence and chronicity, prevent recurrent events and hospitalizations
  5. To develop the efficacy criteria for medical rehabilitation on each stages of rehabilitation and establishing the logistic pathways for patients during rehabilitation
  6. To implement the educational programmes for personnel on PRM according to the European model.
  7. Preparation for introducing the new specialty in Russia - doctor of PRM
  8. To establish the financial methods of calculating the costs and tariffs of rehabilitation care for patients with different diseases/conditions in each stage of rehabilitation and in medical organizations of different levels
  9. To improve the financial efficacy of medical rehabilitation and substantiation for new tariff prices for rehabilitation care
  10. To demonstrate the effectiveness of the "new" model of medical rehabilitation system compared to the traditional model in the multicenter study, in patients with ACE, AMI and THR.
  11. To evaluate the clinical efficacy of the "new" model of medical rehabilitation compared to the "old" model in patients with ACE, AMI and THR by following indicators: in-hospital and 3-months mortality , the number of complications, length of hospital stay, the degree of recovery of functions, activities and participation. To calculate the economic advantage of the "new" model of medical rehabilitation in patients with ACE, AMI and THR by the calculation of the financial cost of one case of and of the complete course of rehabilitation To study characteristics of disorders of functioning and participation. To develop the methodological framework for the establishment of a register of patients receiving rehabilitation in Russia.
  12. To develop basics for establishing a quality assessment system of rehabilitative care in the Russian Federation.

The differences between the new and the old model of rehabilitation are:

  1. The doctor-patient relationship In the old model - Patient is passive recipient of the service In the new model - The patient-oriented approach
  2. Diagnosis In the old model -According to the International Classification of Diseases (ICD-10) In the new model - ICD -10 and ICF
  3. Doctors tasks In the old model - To assign the necessary consultation of experts conducting rehabilitation activities in accordance with the standard of care. In the new model - To organize the discussion about the patients problems, to formulate how to achieve the goals of rehabilitation and short-term and long-term outcomes, to evaluate the criteria of rehabilitation treatment, to organize an effective use of time and equipment required for rehabilitation adequately address problems of technology
  4. Education In the old model - Education on separated specialties on physiotherapy (kinesiotherapy), acupuncture (RTI), massage therapy, speech therapy, etc. In the new model - The unified system of education for all professionals for medical rehabilitation in accordance with the European training program for the doctor of Physical and Rehabilitation Medicine, the modular principle, network form of educational programs
  5. Work organization In the old model - Everyone works in accordance with the official duties, each expert is free to decide what treatment should be done for patient (kinesiotherapist, psychologist etc) In the new model - Multidisciplinary approach. Experts in the joint discussion set the goal of rehabilitation, tasks, time solutions, performers, based on the patient's needs.
  6. The composition of the rehabilitation team In the old model - Instructor-methodologist and exercise therapy doctor, physiotherapy doctor and nurse, massage nurse, speech therapist, clinical psychologist, nurse In the new model - Clinician on relevant specialty, the instructor-methodologist of physical therapy and a physician, doctor and nurse on physiotherapy, ergotherapist, physiotherapy instructor, massage nurse, a speech therapist, a clinical psychologist , nurse
  7. length of stay In the old model -Fixed (14, 21 and 30 days, depends on the stage of rehabilitation) in accordance with the National regulations of care In the new model -Duration of stay in this programme depends on the goals and objectives individually for each patient. When the goals, objectives and the achievement of certain clinical / instrumental parameters are reached patient is transferred to the next stage or discharged
  8. The criteria to refer of patient to the next stage of rehabilitation In the old model -completion of the standard course of care In the new model -A single algorithm for completion of rehabilitation at a certain stage (for all project participants) when the goals and objectives are reached
  9. Payment case In the old model -Fixed tariff for the completed case Diagnosis related group (DRG) In the new model -According to clinical and statistical group on each of the three stages of rehabilitation - case mix group (CMG)
  10. The volume of work done In the old model -According to the regulations and standards of treatment In the new model -Required to achieve the objectives in each case
  11. An audit of the rehabilitation measures In the old model -no In the new model -Internal and external Inclusion/exclusion criteria The inclusion and exclusion criteria to the programme are defined by the Russian professional association (ARUR) and more precisely described in the Protocols of Pilot Project (Neurology, Cardiology and Orthopedia Protocols, respectively).

The Programme is focused on adult patients of any gender and age more than 18 y.o., with the next conditions:

  1. Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
  2. Acute myocardial infarction (AMI, specialty cardiology)
  3. Patients after total hip replacement (THR, specialty orthopaedia)

Our management of stroke, AMI and THR refers to international guidelines although scientific evidence is still lacking for some physical techniques. Our programme is based on an individual approach of each patient. During different phases of the diseases we put emphasis on adequate drug treatment, increasing of exercise's tolerance, gradual mobilization and verticalization with simultaneous improvement of daily activity, increasing of mobility and self-servicing, improvement of activity and participation.

Safety and patient rights are defined by National regulations, national law and internal rules. Each patient signs an informed consent form. Each patient signs an informed consent. The patient and his/her relatives are invited to participate in multidisciplinary team meetings.

All patient's medical and functional information, assessment and further monitoring data is recorded manually into a standardized medical documentation. It is fulfilled at the entry and on discharge from each level of the treatment. All the Programme documents are stored in the clinical archive and are accessible for periodic internal or external audit and outcomes assessment.

One of the most features of the Pilot Project in Russia is the using of ICF for the assessment of efficacy of medical rehabilitation and for the configuring of activity for individualized rehabilitation processes For each model of patient included to the Pilot Project the set of domains of ICF have been created . Analysis of ICF domains will be done automatically by the soft "ICF-reader". The program "ICF-reader" also can help to generate documentation for the adoption of the patient or the patient's discharge or transfer. The main function of the "ICF-reader" is the accumulation and analysis of all the data.

Each patient is assigned a unique number, which allows to identify him/her at the electronic database of the program "ICF-reader".

Each center is responsible for working with the program "ICF-reader". In the second phase of the Pilot Project, program "ICF-reader" will give an opportunity to establish a rehabilitation diagnosis on the basis of the ICF, and the option for ICF assessment using rating scales.

At the 1st stage of rehabilitation patients to be included to the programme after detailed examination, stabilization of condition and assessment of rehabilitation potential. On the basis of primary examination with the using of ICF tools individualized programme of rehabilitation, goals of rehabilitation and methods and technologies are established.

The transfer of patient from one stage of rehabilitation to another depends on:

achievement of defined goals and functional parameters (data of laboratory, instrumental, functional methods, results of clinical examination by appropriate scales), assessment of activity and participation achievement of requirements of National regulations (number of appropriate diagnostic methods, prespecified treatment, prevention procedures etc) The degree of functional disturbances is assessed by appropriate diagnostic methods: laboratory, instrumental and clinical .

Referral patients: At the 1st stage of rehabilitation (in acute unit) patients should be included to rehabilitation process during the first 48 hours after onset of event or surgery after examination of doctor (trained on PRM) and other members of multidisciplinary team. Each member of multidisciplinary team assesses a patient at the beginning and at the end of each stage of rehabilitation by appropriate pre-defined clinical scales.

At the 2nd stage of rehabilitation patients should be included to rehabilitation process just after admission from the 1st stage (by referral of PRM doctor of the 1st stage) At the 3rd stage of rehabilitation patients should be included to rehabilitation process after admission from the 1st or 2nd stages (by referral of PRM doctor of the 1st or 2nd stages, by referral of general practitioner after assessment of multidisciplinary team).

Being tested
Scales, New model of rehabilitation, Old model of rehabilitation, ICF reader
Keywords
Rehabilitation, ICF, Pilot project, Stroke, Acute myocardial infarction, Total hip replacement
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ScalesOther

    For stroke patients there are used scales:

    Modified Rankin Scale, NIH Stroke Scale , Glasgow Coma Scale, Dysphagia Severity, Rating Scale Speech or Language Impairment Severity Rating Scale, Modified Rivermead Mobility Index, Berg Balance Scale, Modified Ashworth Scale, Medical Research Council Scale, Frenchay Arm Test, Montreal Cognitive Assessment Scale, Spielberger Scale, Beck's Depression Inventory, Visual Analogue Scale, Functional Independence Measure For patients after AMI: Rankin scale, GRACE scale, MoCA, VAS, Hospital scale of anxiety and depression, Canadian classification if stenocardia

    For patients after THR:

    The pain of the operated joint on VAS scores The Harris scale (the total amount), Scale Lequesne (total), Hospital scale of anxiety

  • New model of rehabilitationOther

  • Old model of rehabilitationOther

  • ICF readerOther

Study groups in NCT02793934
Study groupRoleWhat they receive
1st phaseIn the 1st phase of the study the staff of the medical organizations continue to work in the familiar "old" scheme, but using the set of scales.
Receives: Other: Scales; Other: Old model of rehabilitation; Other: ICF reader
2nd phaseIn the 2nd phase, medical organizations will start to work on a new model with the implementation of problem-oriented multidisciplinary approach and the use of modern rehabilitation technologies. There is planning to use clearly defined criteria for transfer from stage to stage, developed by the professional community. When doctors will be trained program "ICF-reader" will have an opportunity to establish a rehabilitation diagnosis on the basis of the ICF, and the option for ICF assessment using rating scales.
Receives: Other: Scales; Other: New model of rehabilitation; Other: ICF reader

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: through study completion, an average of 1 month

  2. Recovery of functions, activity and participation

    modified Renkin scale)

    Measured: through study completion, an average of 1 month

Secondary outcomes (9)
  1. Mortality

    Measured: 90 days after discharge

  2. Recovery of functions, activity and participation

    Measured: 90 days after discharge

  3. Environmental adaptation

    Measured: 90 days after discharge

  4. Preventable conditions

    Pain Trophic disturbances Muscle tonus disturbances Contractures Cognitive disorders Inadequate tolerance Social disadaptation etc

    Measured: 90 days after discharge

  5. Time of start of rehabilitation

    Measured: through study completion, an average of 1 month

  6. Time of the first, interim and final expert assessment of rehabilitation potential

    Measured: through study completion, an average of 1 month

  7. Duration of hospitalization

    Measured: through study completion, an average of 1 month

  8. Duration of rehabilitation process for the achievement the goals for each stage of rehabilitation

    Measured: through study completion, an average of 1 month

  9. Duration of rehabilitation process from onset of disease to final or to transfer the patient or to establishing the disability

    Measured: through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02793934
Sponsor's protocol ID
DOME
Status last verified
Apr 2018
First submitted
15 May 2016
Last updated
26 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

    PubMed 27145936
  • Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.

    PubMed 16120836
  • Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.

    PubMed 20813995
  • Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.

    PubMed 10137673
  • Pollock N, Baptiste S, Law M, McColl MA, Opzoomer A, Polatajko H. Occupational performance measures: a review based on the guidelines for the client-centred practice of occupational therapy. Can J Occup Ther. 1990 Apr;57(2):77-81. doi: 10.1177/000841749005700206.

    PubMed 10106647
  • Kube E, Erhardt E. [Drug abuse prevention by police educational measures--Some remarks]. Arch Kriminol. 1991 Jan-Feb;187(2):23-7. No abstract available. German.

    PubMed 2036055
  • Robbins CE, Casey D, Bono JV, Murphy SB, Talmo CT, Ward DM. A multidisciplinary total hip arthroplasty protocol with accelerated postoperative rehabilitation: does the patient benefit? Am J Orthop (Belle Mead NJ). 2014 Apr;43(4):178-81.

    PubMed 24730003

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and AMI, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ivanova Galina, Professor (+79161144504, reabiivanova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: through study completion, an average of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02793934, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.

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