Quality of Life Clinical Trial
Official title:
Social Support and Health in Fibromyalgia
This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. We randomly assigned the study participants to one of three groups. People in the social support group met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The social support and education group also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS. Members of this group learned about the disease and ways they can manage it themselves. The third group participated only in the five assessment periods. The study lasted 4 years.
Next to osteoarthritis, FMS is the most common arthritis-related disease. Symptoms include
musculoskeletal pain, fatigue, headaches, irritable bowel syndrome, morning stiffness, and
sleep disturbances. Fluctuating severity, pain, and frustration with the difficulty of
diagnosis and treatment lead patients to continually seek help from health care
professionals. There is no known cause or cure for this disease.
This study tests the effects of social support and education on the health and well-being of
people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS
from a large health maintenance organization. To be eligible, people had to meet the
American College of Rheumatology guidelines for FMS. After we confirmed the diagnosis, we
assigned those who agreed to participate to one of three groups. The first group (social
support) met with others who suffer from FMS for 2 hours every week for 10 weeks, and then
monthly for an additional 10 months. The second group (social support and education) also
had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from
FMS, and its members learned about the disease and self-management techniques. The third
group (control) participated only in the five assessment periods. We assessed people in all
three groups before we assigned them to a group, after the intervention, and at yearly
follow-ups. The study duration was 4 years.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
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