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| Descriptive Information Fields | |||||
| Brief Title † | Support, Health, and Fibromyalgia | ||||
| Official Title † | Social Support and Health in Fibromyalgia | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Fibromyalgia Quality of Life |
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| Intervention † | Behavioral: Social support group Behavioral: Social support and education group |
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| MEDLINE PMIDs | 11764222 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 600 | ||||
| Start Date † | September 1996 | ||||
| Completion Date | February 2001 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000423 | ||||
| Organization ID | R01 AR44020 | ||||
| Secondary IDs †† | NIAMS-029 | ||||
| Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2001 | ||||
| First Received Date † | November 3, 1999 | ||||
| Last Updated Date | December 28, 2006 | ||||