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临床试验/NCT01572051
NCT01572051已完成不适用

Project Osteoarthritis: Recovering Quality of Life Through Education

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2011年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
2
主要终点
The benefit of Education in the treatment of knee OA

研究概览

简要总结

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.

详细描述

INTRODUCTION

Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of patients. Patients can become disabled early in life by OA.(1,2,3) Osteoarthritis is primarily a genetic disease but can be triggered by trauma, intra-articular fractures, axis deviations and joint overloading, including overweight / obesity.

Perhaps the most common type of disease is hand OA, as debilitating to the patient as the changes generated by rheumatoid arthritis. On the other hand, among the most debilitating, is knee OA, that greatly diminish the quality of life of the affected patients. (4) At the Knee Surgery Group of Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IOT-HCFMUSP) - Orthopedics and Trauma Institute of University of São Paulo's General Hospital - there is a large number of young adult patients who were economically active, until the advent of a joint trauma, which led to early OA. There is also a large number of people seeking our group for a Total Knee Arthroplasty (TKA) without been offered all non-surgical alternatives of treatment. As there are also patients who underwent surgical treatment but suffer from consequences of OA and clinical treatment is their current need. These patients do not receive an appropriate OA clinical care.

Those patients should be reabsorbed by the basic health network. But the patient is returned by the social services at IOT-HCFMUSP, because there is no such reference in the Unified Health System The 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. Those guidelines show the importance of education, phone calls, non-drug methods such as physical therapy, exercise, acupuncture, mind and body therapies, the use of insoles and orthotics, canes, crutches and knee pads, and finally the drugs for pain and to slow the progression of the disease. (5,6) It is believed that an education program has a positive impact on quality of life of patients with OA. In England, the simple delivery of educational material showed no different from a course associated with the delivery of educational material. But in countries like Sweden, primary care is concerned to give courses on OA. In France, teaching about the pathology associated with medical consultation was superior to simple medical consultation to improve patients' symptoms and treatment adherence. (6) No paper on only telephone follow-up was performed, but the addition of patient care by phone, always shows better results than a single intervention. (6) The Osteometabolic Diseases Group of IOT-HCFMUSP, initially focused on the care of osteoporosis and other diseases of bone metabolism such as thalassemia and osteogenesis imperfecta. More recently took over the care and research in the treatment of OA, starting with the knee OA, since it's among the most prevalent and debilitating types of OA.(3)

Obesity and knee OA are the most frequent comorbidities in the elderly in the United States (U.S.). Although not presenting the same level of obesity of U.S. patients, our patients with OA also are overweight, and often have diabetes and hypertension. Changing the habits of those patients is imperative for clinical improvement. Those patients should incorporate healthier eating habits as well as daily physical activity. But to change behavior, it is necessary:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Group 1A (3month plus phone)

Experimental

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

干预措施: Educational Course (Behavioral)

Group 1A (3month plus phone)

Experimental

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

干预措施: Phone Calls (Behavioral)

Group 3A (1month plus phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 3B (1month no phone)

Experimental

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

干预措施: Educational Course (Behavioral)

Group 3B (1month no phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 3A (1month plus phone)

Experimental

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

干预措施: Phone Calls (Behavioral)

Group 1A (3month plus phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 1B (3month no phone)

Experimental

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

干预措施: Educational Course (Behavioral)

Group 1B (3month no phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 2A (2month plus phone)

Experimental

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

干预措施: Educational Course (Behavioral)

Group 2A (2month plus phone)

Experimental

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

干预措施: Phone Calls (Behavioral)

Group 2A (2month plus phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 2B (2month no phone)

Experimental

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

干预措施: Educational Course (Behavioral)

Group 2B (2month no phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 3A (1month plus phone)

Experimental

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

干预措施: Educational Course (Behavioral)

Group 4A (no course plus phone)

Experimental

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

干预措施: Phone Calls (Behavioral)

Group 4A (no course plus phone)

Experimental

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

干预措施: Printed Material (Behavioral)

Group 4B (no course no phone)

Experimental

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

干预措施: Printed Material (Behavioral)

结局指标

主要结局

The benefit of Education in the treatment of knee OA

时间窗: up to12 months

To access the results of education on the knee OA outcome

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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