Support, Health, and Fibromyalgia

NCT00000423 | Completed Phase 2

• 2 other identifiers: R01AR044020NIAMS-029
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Quality of Life

Keywords

Fibromyalgia; Health education; Program evaluation; Social support; Managed care; Quality of well-being

Interventions

Social support group BEHAVIORAL

Social support and education group BEHAVIORAL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of fibromyalgia documented in medical records and confirmed using The American College of Rheumatology criteria for classification of FMS: (1) A history of widespread pain (pain on both sides of the body, above and below the waist, and present for at least 3 months). (2) Pain in 11 or more of 18 tender-point sites.
• Patient willing to attend 10 weekly meetings and 10 monthly meetings.

You may not qualify if:

• Patients who do not meet ACR criteria for FMS described above.
• Patients who cannot attend meetings once a week for 10 weeks and once a month for 10 months were excluded.

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92120, United States

Location

Related Publications (1)

• Oliver K, Cronan TA, Walen HR, Tomita M. Effects of social support and education on health care costs for patients with fibromyalgia. J Rheumatol. 2001 Dec;28(12):2711-9.

  PMID: 11764222 RESULT

MeSH Terms

Conditions

Fibromyalgia; Health Education

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Thereasa A. Cronan

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 1, 1996
• Study Completion: February 1, 2001
• Last Updated: December 4, 2013

Record last verified: 2001-03

Locations

US (1)