Project Osteoarthritis: Recovering Quality of Life Through Education
PARQVE
1 other identifier
interventional
228
1 country
1
Brief Summary
Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of patients. Patients can become disabled early in life by OA. The Osteoarthritis Research Society International (OARSI) is concerned to publish guidelines with the respective levels of evidence on the various forms of treatment of osteoarthritis of the knee and hip.It is believed that an education program has a positive impact on quality of life of patients with OA. Changing the habits of those patients is imperative for clinical improvement. The investigators propose the creation of an educational program consisting of various health professionals so that we can educate the patients about OA disease, and their role in treatment. This program will be administered in a single day and reviewed/reinforced after an interval of time. Half the patients will be monitored monthly by phone when questions specific to each health area will be made to participants. This way we will evaluate the strength of the telephone follow-up. The investigators are going to create educational printed an audiovisual materials for patients, so the patients can access the information given in the theoretical course at home. Calculation of cost-effectiveness and presentation of data to the authorities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJanuary 15, 2015
October 1, 2013
2 years
January 23, 2012
January 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The benefit of Education in the treatment of knee OA
To access the results of education on the knee OA outcome
up to12 months
Secondary Outcomes (3)
The benefit of phone calls in the treatment of knee OA
3,6 and 12 months
Length of interval between interventions
3,6 and 12 months
Which is the best education program - Having classes or only receiving printed material?
3,6 and 12 months
Study Arms (8)
Group 1A (3month plus phone)
EXPERIMENTALThis group will attend to two courses with a 3 month interval between them This group will receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 1B (3month no phone)
EXPERIMENTALThis group will attend to two courses with a 3 month interval between them This group will NOT receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 2A (2month plus phone)
EXPERIMENTALThis group will attend to two courses with a 2 month interval between them This group will receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 2B (2month no phone)
EXPERIMENTALThis group will attend to two courses with a 2 month interval between them This group will NOT receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 3A (1month plus phone)
EXPERIMENTALThis group will attend to two courses with a 1 month interval between them This group will receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 3B (1month no phone)
EXPERIMENTALThis group will attend to two courses with a 1 month interval between them This group will NOT receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 4A (no course plus phone)
EXPERIMENTALThis group will NOT attend to any courses This group will receive phone calls This group will receive printed material This group will be reassessed in 6 months
Group 4B (no course no phone)
EXPERIMENTALThis group will NOT attend to any courses This group will NOT receive phone calls This group will only receive printed material This group will be reassessed in 6 months
Interventions
2 Educational courses
Phone Calls
Printed Material
Eligibility Criteria
You may qualify if:
- Men and women diagnosed with primary or secondary osteoarthritis of the knees,classified as grades I to IV Kelgreen and Lawrence (KL), ie, any degree of knee osteoarthritis
You may not qualify if:
- Patients who have psychiatric or neurological disorders, whose symptoms during the evaluation to the school are related or significantly interfere in the functions of attention, memory, logical reasoning, understanding and interaction with the group in order to undermine the assimilation of the guidelines given
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo
São Paulo, São Paulo, 05403-010, Brazil
Related Publications (1)
de Rezende MU, de Farias FES, da Silva CAC, Cernigoy CHA, de Camargo OP. Objective functional results in patients with knee osteoarthritis submitted to a 2-day educational programme: a prospective randomised clinical trial. BMJ Open Sport Exerc Med. 2017 Feb 14;2(1):e000200. doi: 10.1136/bmjsem-2016-000200. eCollection 2016.
PMID: 28879035DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcia U Rezende, Phd
Hospital das Clínicas da Universidade de São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2012
First Posted
April 5, 2012
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2014
Last Updated
January 15, 2015
Record last verified: 2013-10