Project Osteoarthritis: Recovering Quality of Life Through Education (PARQVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01572051
First received: January 23, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Knee Osteoarthritis
Behavioral: Educational Course
Behavioral: Phone Calls
Behavioral: Printed Material

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Project Osteoarthritis: Recovering Quality of Life Through Education

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • The benefit of Education in the treatment of knee OA [ Time Frame: up to12 months ] [ Designated as safety issue: No ]
    To access the results of education on the knee OA outcome


Secondary Outcome Measures:
  • The benefit of phone calls in the treatment of knee OA [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
    To access if we can improve knee OA treatment outcomes with phone calls

  • Length of interval between interventions [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
    To access what's the optimum interval length between interventions

  • Which is the best education program - Having classes or only receiving printed material? [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
    Which is the best education program - Having classes or only receiving printed material?


Estimated Enrollment: 240
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1A (3month plus phone)
This 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
Behavioral: Educational Course
2 Educational courses
Behavioral: Phone Calls
Phone Calls
Behavioral: Printed Material
Printed Material
Experimental: Group 1B (3month no phone)
This 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
Behavioral: Educational Course
2 Educational courses
Behavioral: Printed Material
Printed Material
Experimental: Group 2A (2month plus phone)
This 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
Behavioral: Educational Course
2 Educational courses
Behavioral: Phone Calls
Phone Calls
Behavioral: Printed Material
Printed Material
Experimental: Group 2B (2month no phone)
This 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
Behavioral: Educational Course
2 Educational courses
Behavioral: Printed Material
Printed Material
Experimental: Group 3A (1month plus phone)
This 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
Behavioral: Educational Course
2 Educational courses
Behavioral: Phone Calls
Phone Calls
Behavioral: Printed Material
Printed Material
Experimental: Group 3B (1month no phone)
This 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
Behavioral: Educational Course
2 Educational courses
Behavioral: Printed Material
Printed Material
Experimental: Group 4A (no course plus phone)
This 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
Behavioral: Phone Calls
Phone Calls
Behavioral: Printed Material
Printed Material
Experimental: Group 4B (no course no phone)
This 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
Behavioral: Printed Material
Printed Material

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572051

Locations
Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Marcia U Rezende, Phd Hospital das Clínicas da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01572051     History of Changes
Other Study ID Numbers: P.A.R.Q.V.E.
Study First Received: January 23, 2012
Last Updated: October 23, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
osteoarthritis
knee osteoarthritis
education

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014