Web-based Education to Enhance Fibromyalgia Management - Full Text View

Sponsor:	University of Michigan
Information provided by (Responsible Party):	David A. Williams, University of Michigan
ClinicalTrials.gov Identifier:	NCT00423631

Sponsor:

University of Michigan

Information provided by (Responsible Party):

David A. Williams, University of Michigan

ClinicalTrials.gov Identifier:

NCT00423631

Purpose

Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 6-month period.

Primary Hypothesis The primary hypothesis of this study is that the number of patients with fibromyalgia who are able to achieve clinically meaningful improvements in physical function will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website.

Secondary Hypotheses

The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website
The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in mood and beliefs about pain will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website

Condition	Intervention
Fibromyalgia Fibrositis	Behavioral: Standard care and web Behavioral: Standard Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Internet-Enhanced Management of Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Fibromyalgia

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Clinically meaningful improvements in physical function (as measured by the SF-36). [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties (as measured by the McGill, MFI and MASQ). [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
Clinically meaningful improvements in mood and beliefs about pain (as measured by the CES-D, STPI, CSQ and BPCQ) [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine whether treatment adherence is superior in one of the treatment arms of the study, and whether adherence is related to improved outcomes. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
To determine whether treatment satisfaction is superior in one of the treatment arms of the study, and whether that satisfaction is related to improved outcomes [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
To determine post hoc, the characteristics of the individuals that achieved treatment success versus those that did not, to better identify the factors that contribute to positive outcomes in this spectrum of illness. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Enrollment:	118
Study Start Date:	September 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Standard Care and Web Standard care plus a web site based on cognitive behavioral principals.	Behavioral: Standard care and web A static web site containing cognitive and behavioral self management instructions.
Active Comparator: Standard Care Subject recieve standard care from their primary care provider.	Behavioral: Standard Care Standard care delivered by the primary care provider.

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

SUBJECTS WILL NEED TO COME TO SIOUX FALLS FOR THE STUDY VISITS.

The study sample will be drawn from a population of individuals diagnosed with fibromyalgia in a five state region consisting of North and South Dakota, Iowa, Minnesota, and Nebraska.

Subjects will be recruited into the study by practicing physicians either at the main hospital in Sioux Falls or in any of 15 affiliated rural clinic study sites. In order to be included in the study, potential subjects must meet the study inclusion and exclusion criteria.

Inclusion Criteria:

Ability to travel to Sioux Falls, SD for study visits.
All subjects must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1990)
Be 18 years of age
All subjects must have been in standard medical care with a physician for at least 3 months.
Subjects must have a home computer or access to a computer with the following features:
- An Internet browser that is Internet Explorer version 5.0 or higher.
- Printer
- Speakers or headphones
- Ability to use e-mail and access to the Internet
Subjects must be able to perform the following screening test designed to assess computer ability:
- Go to a webpage Log in to a website
- Click on an icon
- Click on a radio button to answer a multiple choice question
- Fill a name into a text box
- Click on a submit button
- Print a document

Exclusion Criteria:

Subjects will be excluded from participation if they have any of the following:

A severe physical impairment that precludes receiving/using the website or using the CBT skills contained on the website (e.g. complete blindness)
Co-morbid medical illnesses capable of causing a worsening of physical functional status independent of fibromyalgia (e.g. morbid obesity, autoimmune diseases,) cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), and malignancy within 2 years.
Any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), current suicide risk or attempt within 2 years of the study, or substance abuse within 2 years. Note: Subjects with mood disorders will not be excluded.
Prior face to face CBT for pain management.
Receiving or applying for or considering seeking disability payments.

Responsible Party:	David A. Williams, Professor, University of Michigan
ClinicalTrials.gov Identifier:	NCT00423631 History of Changes
Other Study ID Numbers:	DAMD 17-002-0018, A-9356.1
Study First Received:	January 17, 2007
Last Updated:	October 6, 2011
Health Authority:	United States: Institutional Review Board

United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105