Creating a Decision Support System for the Corporate Management of Physical Therapy

NCT03586401 | Unknown

• 1 other identifier: 9э/4-17
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to create a software product on the basis of the support technologies for making decisions for the collaboration of the different specialists, the family and the patient himself in the process of physical therapy of children treated for cancer. The basic model of the technology is a qualification model of the state of health and physical limitations, based on data from a survey of 1,000 children treated for cancer. The software product is supposed to be created on the basis of the Splunk system, the key link is a personal office with a two-way login system: for specialists and for patients. The patient introduces the results of self-examination, monitoring and additional surveys in real time, specialists - additional recommendations. To assess the effectiveness of the collaboration based on the software product, a long-term follow-up (at least 3 years) is planned for the participants of the study with repeated examinations at the Medical-Rehabilitation Scientific Center "Russe pole" at least twice a year. Condition or disease Hemoblastosis Solid brain tumors The condition after hematopoietic stem cell transplantation

Conditions

Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Brain Tumor; Physical Activity; Physical Disability

Keywords

Children who have been treated for cancer; Qualification of health; Physical insolvency; Late toxic effects; Physical therapy; Physical activity; Systems for decision making support

Outcome Measures

Primary Outcomes (1)

• Self-assessment of motor activity

  Based on The International Physical Activity Questionnaire (IPAQ). The patient or his parents fill out a special questionnaire, that contains questions about the motor activity in 4 areas: leisure, activity at home and in the garden, activities related to work and activities related to transport. The main indicator is the the MET (Metabolic Equivalent of Task) per week: MET level x minutes of activity x events per week. Three levels (categories) of physical activity are proposed. High - 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week Moderate - 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week. Low - Those individuals who not meet criteria for categories 1 or 2 are considered low/inactive.

  at least 12 studies with an interval of not more than 2 months, a total period of 2 years

Secondary Outcomes (9)

• Myocardial contractility

  at least 4 studies with an interval of not more than 6 months, a total period - 2 years

• The response of the vascular system to submaximal load (6-minute walk test)

  at least 4 studies with an interval of not more than 6 months, a total period - 2 years

• The neuromuscular support of physical activity

  at least 4 studies with an interval of not more than 6 months, a total period - 2 years

• Strength endurance of the main muscle groups

  at least 4 studies with an interval of not more than 6 months, a total period - 2 years

• Energy costs for physical activity

  at least 4 studies with an interval of not more than 6 months, a total period - 2 years

Study Arms (1)

Childhood Cancer Survivors

The study will be attended by 1000 families with children who have completed treatment for cancer at least 6 months before the start of the trial and undergo rehabilitation courses at the Medical and Rehabilitation Research Center "Russkoe pole" at least twice a year.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be attended by 1000 families with children who have completed treatment for cancer on at least 6 months before the start of the trial and undergo rehabilitation courses at the Medical-Rehabilitation Research Center "Russkoe pole" at least twice a year.

You may qualify if:

• Signing of the agreement with the Medical-Rehabilitation Scientific Center "Russkoe pole".
• Persistent remission not less than 6 months after.
• Age not less than 4 years and not more than 16 years at the time of signing the agreement on participation in the protocol.
• Collaboration with the patient's family and the patient.

You may not qualify if:

• The occurence of second tumors.
• Recurrence of cancer.
• Failure to fulfill the obligations under the contract, failure to attend the next survey.

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Vladimir N. Kasatkin, professor

  The National Medical Research Center of Children's Hematology, Oncology and Immunology named after Dmitry Rogachev of the Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serafima M. Chechelnitskaya, professor

CONTACT

+79168128163; dar-2006@bk.ru

Alexandra V. Baerbakh

CONTACT

+79851646997; baer83@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Rehabilitation Department

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 13, 2018
• Study Start: November 1, 2017
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2020
• Last Updated: July 13, 2018

Record last verified: 2018-06

Locations

RU (1)