Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01572051 |
| Other study ID # |
P.A.R.Q.V.E. |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 23, 2012 |
| Last updated |
January 14, 2015 |
| Start date |
October 2011 |
| Est. completion date |
October 2014 |
Study information
| Verified date |
October 2013 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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:
- to perceive the problem as important and serious.
- to perceive that behaviour change is beneficial. Patients are more prone to health
information when it is presented in terms of potential gain (11) and when these gains
are presented in patients of the same sex and race. (12)
We have a diverse population of patients with level of education ranging from illiterate
patients at university level. With this diversity of patients, and a number of patients who
can easily reach four digits, and the total lack of possibility of referral of patients to
primary or secondary care in the city of São Paulo, we designed a pilot program in three
phases:
Phase 1 - 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. We're going to create educational printed an audiovisual materials for patients,
so they can access the information given in the theoretical course at home. Calculation of
cost-effectiveness and presentation of data to the authorities.
Phase 2 - If we can demonstrate effectiveness in improving the quality of life of patients,
we will hold training courses for health professionals from the West Region Project to
create a system of reference and cross-reference with the primary and secondary care
centers. Patients who have been through the course and demonstrate improved quality of life,
will be accompanied closer to their homes in the western region of São Paulo.
Phase 3 - Expansion to all the city of São Paulo and other cities.
In this pilot, we focus exclusively on Phase 1.
The variables that can interfere with patient compliance to the program and, therefore, to
the final result, are:
- Length of Interval between interventions (1, 2 or 3 months)
- Phone follow-up or not
- Attending the course or just receiving the educational material
GENERAL OBJECTIVES To assess the improvement of quality of life of patients with
osteoarthritis exposed to an education program multi-professional and / or telephone
follow-up.
Develop knowledge, experience and indicators that support the expansion of the project to:
West Region Project Municipal Programs, State and National.
Subprojects:
Social Work - improving the quality of life by the introduction of leisure Nutrition -
Decrease in body mass index (BMI) by improving the quality and quantity of diet.
Physical Therapy - Improves the autonomy, function and pain for the introduction of daily
exercise habits.
Occupational Therapy - Improves autonomy, function and pain by improving the ergonomics
and-administration of daily tasks.
Physical Education - Improvement of autonomy, function and pain for the introduction of
daily exercise habits.
Psychology - Improving quality of life for the patient and behavior change induced by the
intervention.
METHODS
Two hundred and forty patients from the public, healthcare at IOT-HCFMUSP, already
identified with OA of the knees
Given the inclusion criteria, patients undergo pre-assessment by the group composed of
multi-professional teams of physicians, orthopedic surgeons, nutritionists, psychologists,
physiotherapists, occupational therapists, social worker, and physical educators:
Orthopedics - We treat patients according to the OARSI guidelines, offering everything at
our disposal for the treatment of OA at IOT-HCFMUSP. Thus, the orthopedic surgeon:
1. - request and evaluate exams, and classify the disease by knees x-rays,
2. - prescribe medications to delay the disease (we work with diacerein in our service),
analgesics, muscle relaxants, and Non-Steroidal anti-inflammatory Drugs (NSAIDs), if
necessary,
3. - prescribe orthotics (insoles, knee pads, sticks and crutches, braces);
4. - will report to Social Security and Departamento de Transportes (DETRAN) - Transports
Department (this, if the social services confirm the need);
5. - Apply evaluation questionnaires SF 36, Visual Analog Pain Scale (VAS), Western
Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in the first visit and
after six months, will make the referral to physiotherapy and physical activity on the
network offered by the government, refers to acupuncture and / or dry needling
physiatry in the IOT-FMUSP for cardiac evaluation and clearance for physical activity.
Apply the Consent Report to patients.
Each of the professional staff will assess the effects of its intervention in a personalized
way through a subproject:
Nutritionist - anthropometric Social Worker - Level of education, autonomy and limited
mobility to the hospital.
Psychologist - assess cognitive ability, application of World Health Organization Quality of
Life (WHOQOL) Physical Therapist - assess range of motion, pain, strength and quality of
life.
Occupational Therapy - range of motion and quality of life. Physical Educator - Evaluate the
physical capacity and prescribe appropriate exercise for the patient.
The 240 patients will be randomly assigned to 4 groups of 60. 3 groups will be subjected to
2 interventions, varying the time interval between each intervention: Group 1 to 3 months
apart Group 2 - 2 months apart Group 3 - 1-month interval
Group 4 will only receive the printed material.
Patient Flow
Interventions take place on Saturdays at IOT-HCFMUSP, using the classrooms and the
dependencies of physiotherapy. We will have a "home simulation" to teach ergonomics in the
home. The course will take place between 8:00 and 17:00 hours.
Course Schedule - 30 students per week 7:00 Reception of patients 8:00 Opening 8:10
Orthopedics Class 8:30 Psychology Class 9:30 Interval - Morning Snack 10:00 Theoretical
Lecture - Physical Therapy 10:20 Theoretical class - Occupational Therapy 10:40 Practices:
Physical Therapy (15 students) and Occupational Therapy (15 students) 12:10 Lunch 13:00
Practices: Physical Therapy (15 students) and Occupational Therapy (15 students 14:30
Nutrition 15:20 Physical Education 15:50 Interval - Afternoon Snack 16:20 Fitness with the
Physical Educator 16:30 Social service 17:00 Closure
COURSE CONTENT
1 st Intervention
Education program for 8 hours, with the multidisciplinary team, covered the following:
Psychologist the disease, the role of team and patient in treatment and self-care
Nutritionist basics of balancing food Social Worker the importance of leisure experiences
and advice about places close to home for recreation and physical activity Physiotherapist
Importance of exercise, activities to do at home, experiences Occupational therapy how to
deal with daily activities and the limitations caused by OA Physical Educator Differences
between physical activity and exercise and the importance for patients with OA Orthopaedist
what is the disease can be treated as the daily self-care.
The program will take place on Saturdays at IOT - HCFMUSP, from 8 am to 17 pm
50% of all groups (number of 30 patients in each group 1A, 2A, 3A, and 4A) will receive
monthly follow-up by phone. Groups 1B, 2B, 3B, and 4B, will not receive phone calls.
2nd Intervention Education program for 8 hours, with the multidisciplinary team in order to
check and reinforce learning of the first intervention.
Psychologist The disease, the role of team and patient in treatment and self-care
Nutritionist Check how patients are feeding anthropometric measures +
Social Worker Check the difficulties encountered by the patient access to physical activity
and leisure
Physiotherapist Assessment of range of motion more reinforcement orientation exercises
Occupational therapy Check the difficulties encountered by patients in their daily
activities
Orthopaedist Check learning about the disease and self-control
Physical Educator Reinforcing the need for physical activity
The program will take place on Saturdays, the premises of the IOT - HC - FMUSP, from 7 am to
16 pm
AGENDA 2nd. INTERVENTION Schedule Activity
07:00 Reception of patients 08:00 Reviews 09:00 Activity 1 - Orthopaedics 09:20 Activity 2 -
Nutrition 10:00 Snack 10:30 Activity 3 - Psychology 11:30 Activity 4 - Physical Therapy
12:30 Lunch 13:30 Activity 5 - Occupational Therapy 14:30 Activity 6 - Social Services 15:30
Assessment Program for Patients and Closure
At the end of 6 months, all groups will return to revaluation with all the teams for
reassessment and analysis of the results.
All professionals involved in the program will be paid. The medications used are those
provided by the HC complex for patients enrolled with a diagnosis of OA. Any medication that
is not in the arsenal of Pharmacy HC for normal service to patients with OA will not be
prescribed.
To carry out the interventions on Saturdays (Saturdays 12 in total) will require support
services that receive extra payment:
- Secretaries
- Food (snacks morning and afternoon + lunch)
- Computer Support
Estimated Number of sample:
This is a pilot study without a similar estimate for the number of patients. The sample was
then left with the number 30 for each subgroup.
Statistical Analysis We will use basic descriptive analysis for sample parameters according
to collected data, and Student t test and U Mann-Whitney test to compare pre and
post-intervention results.
