Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167271
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2005-09-09
Brief Title:
Promoting Health in People With Fibromyalgia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Efficacy of Computer and SenseWear Technologies for Promoting Health in People With Fibromyalgia A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia
Detailed Description:
Fibromyalgia is among the most common diffuse pain syndromes affecting about 1 of every 10 rheumatology patients People with fibromyalgia experience widespread chronic pain and fatigue that negatively influences their activity participation causes disability and overall quality of life
The purpose of this 3-year study is to use a cognitive-behavioral intervention to facilitate adoption of a wellness lifestyle in people with fibromyalgia Specifically we will test the efficacy of a health promotion computer program Balance Center used in conjunction with a wearable sensor SenseWearTM for developing a wellness lifestyle and improving the quality of life of adults with fibromyalgia Balance Center software is a health promotion computer program that helps consumers to 1 establish goals in the areas of physical activity nutrition participation in meaningful productive activities sleep stress-reducing activities and emotional state 2 monitor progress toward established goals and 3 assess the relationship between these areas in ones daily life In addition based on consumer input it offers suggestions for developing a wellness lifestyle SenseWearTM provides objective data about activity level and stress level for consumers to use in combination with the self-assessment data provided by the Balance Center
In this randomized controlled clinical trial the Experimental Balance Center SenseWearTM Intervention is compared to a Usual Care control group Seventy-two adults 36 Experimental 36 Control with fibromyalgia will be randomized and followed for 6 weeks exclusive of Baseline and Posttesting The hypotheses to be tested are Participants randomized to the Experimental Condition will demonstrate significantly a more physical activity b a healthier wellness lifestyle and c fewer symptoms of fibromyalgia In addition the relationship between the decrease in fibromyalgia-related impairment on daily life and physical activity and a wellness lifestyle will be stronger at Posttesting than at Baseline in the Experimental Group compared to the Control Group The anticipated outcome of the intervention is more effective self-management of lifestyle and symptoms so that one can live well with fibromyalgia
The purpose of this 3-year study is to use a cognitive-behavioral intervention to facilitate adoption of a wellness lifestyle in people with fibromyalgia Specifically we will test the efficacy of a health promotion computer program Balance Center used in conjunction with a wearable sensor SenseWearTM for developing a wellness lifestyle and improving the quality of life of adults with fibromyalgia Balance Center software is a health promotion computer program that helps consumers to 1 establish goals in the areas of physical activity nutrition participation in meaningful productive activities sleep stress-reducing activities and emotional state 2 monitor progress toward established goals and 3 assess the relationship between these areas in ones daily life In addition based on consumer input it offers suggestions for developing a wellness lifestyle SenseWearTM provides objective data about activity level and stress level for consumers to use in combination with the self-assessment data provided by the Balance Center
In this randomized controlled clinical trial the Experimental Balance Center SenseWearTM Intervention is compared to a Usual Care control group Seventy-two adults 36 Experimental 36 Control with fibromyalgia will be randomized and followed for 6 weeks exclusive of Baseline and Posttesting The hypotheses to be tested are Participants randomized to the Experimental Condition will demonstrate significantly a more physical activity b a healthier wellness lifestyle and c fewer symptoms of fibromyalgia In addition the relationship between the decrease in fibromyalgia-related impairment on daily life and physical activity and a wellness lifestyle will be stronger at Posttesting than at Baseline in the Experimental Group compared to the Control Group The anticipated outcome of the intervention is more effective self-management of lifestyle and symptoms so that one can live well with fibromyalgia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None