The Pilot Project Development Of MEdical Rehabilitation System in Russian Federation

NCT02793934 | Unknown

• 1 other identifier: DOME
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.Acute cerebrovascular events (ACE, ischemic stroke or intracerebral hemorrhage - specialty neurology)
2. 2.Acute myocardial infarction (AMI, specialty cardiology)
3. 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).

Conditions

Stroke; AMI; Total Hip Replacement

Keywords

Rehabilitation; ICF; Pilot project; Stroke; Acute myocardial infarction; Total hip replacement

Outcome Measures

Primary Outcomes (2)

• Mortality

  through study completion, an average of 1 month

• Recovery of functions, activity and participation

  modified Renkin scale)

  through study completion, an average of 1 month

Secondary Outcomes (9)

• Mortality

  90 days after discharge

• Recovery of functions, activity and participation

  90 days after discharge

• Environmental adaptation

  90 days after discharge

• Preventable conditions

  90 days after discharge

• Time of start of rehabilitation

  through study completion, an average of 1 month

Other Outcomes (4)

• Criteria of rehabilitation potential

  up to 6 months

• Criteria for the transferring to the next stage or to another hospital

  up to 6 months

• Case mix groups on basic functional disturbances (by ICF)

  up to 6 months

Study Arms (2)

1st phase

In 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.

Other: Scales; Other: Old model of rehabilitation; Other: ICF reader

2nd phase

In 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.

Other: Scales; Other: New model of rehabilitation; Other: ICF reader

Interventions

Scales OTHER

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

1st phase; 2nd phase

New model of rehabilitation OTHER

2nd phase

Old model of rehabilitation OTHER

1st phase

ICF reader OTHER

1st phase; 2nd phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead
• Ministry of Health, Russian Federation: collaborator
• Pirogov Russian National Research Medical University: collaborator
• Voino-Yasenetsky Krasnoyarsk State Medical University: collaborator
• Vladivostok State Medical University: collaborator
• Ural district Institute of Brain: collaborator
• Nizhegorodskoye Federal State Unitary Enterprise: collaborator

Study Sites (1)

StPetersburgSPMU

Saint Petersburg, 197022, Russia

RECRUITING

Related Publications (7)

• 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.

  PMID: 27145936 RESULT

• 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.

  PMID: 16120836 RESULT

• 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.

  PMID: 20813995 RESULT

• 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.

  PMID: 10137673 RESULT

• 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.

  PMID: 10106647 RESULT

• 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.

  PMID: 2036055 RESULT

• 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.

  PMID: 24730003 RESULT

Related Links

• Guidelines for Client-centered Practice of Occupational Therapy) (DNHW \& CAOT, 1985)
• Management of patients with stroke: Rehabilitation, prevention and management of complications, and discharge planning. June 2010. SIGN. A national clinical guideline. Scottish Intercollegiate Guidelines Network.
• Stroke rehabilitation guide: supporting London commissioners to commission quality services in 2010/11. NHS. Healthcare for London.
• ICF

MeSH Terms

Conditions

Stroke

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Shmonin Alexey, PhD

  St. Petersburg State Pavlov Medical University

  PRINCIPAL INVESTIGATOR

• Shamalov Nikolay, Professor

  Pirogov Russian National Medical Research University

  PRINCIPAL INVESTIGATOR

• Suvorov Andrey, PhD

  Pirogov Russian National Medical Research University

  PRINCIPAL INVESTIGATOR

• Buylova Tatiana, Professor

  Rehabilitation Center of Federal State Unitary Enterprise Nizhegorodskoye PROP

  PRINCIPAL INVESTIGATOR

• Tsykunov Mikhail, Professor

  Central Research Institute of Traumatology and Orthopedics . Priorov Russian Ministry of Health

  PRINCIPAL INVESTIGATOR

• Belyaev Anatoliy, Professor

  Vladivostok State Medical University

  PRINCIPAL INVESTIGATOR

• Prokopenko Sergei, Professor

  Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky

  PRINCIPAL INVESTIGATOR

• Khasanova Dina, Professor

  Kazan State Medical University Russian Ministry of Health

  PRINCIPAL INVESTIGATOR

• Bodrova Rezeda, PhD

  Kazan State Medical Academy

  PRINCIPAL INVESTIGATOR

• Aronov David, Professor

  State Research Center for Preventive Medicine Health Ministry of Russia

  PRINCIPAL INVESTIGATOR

• Bubnova Marina, Professor

  State Research Center for Preventive Medicine Health Ministry of Russia

  PRINCIPAL INVESTIGATOR

• Belkin Anatoliy, Professor

  Ural State Medical University Russian Ministry of Health

  PRINCIPAL INVESTIGATOR

• Mishina Irina, Professor

  Ivanovo State Medical Academy Russian Ministry of Health

  PRINCIPAL INVESTIGATOR

• Sarana Andrey, PhD

  Saint-Petersburg City Hospital № 40 of Recreation Area

  PRINCIPAL INVESTIGATOR

• Ivanova Natalya, Professor

  Russian Research Neurosurgical Polenovs Institute

  PRINCIPAL INVESTIGATOR

• Yashkov Alexander, Professor

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

• Maltseva Mariya, Professor

  St. Petersburg State Pavlov Medical University

  PRINCIPAL INVESTIGATOR

• Soloveva Liudmila, MD

  St. Petersburg State Pavlov Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivanova Galina, Professor

CONTACT

+79161144504; reabiivanova@mail.ru

Melnikova Elena, Professor

CONTACT

+7 (911) 743-15-08; melnikovae2002@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: June 8, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)