Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The overall objective of this randomized controlled study (RCT) financed by the Norwegian Research Council (grant no. 182012/V50) is to establish the effectiveness of situational feedback to the self-management of fibromyalgia syndrome (FMS) using innovative means of patient-provider communication in a randomized controlled study (RCT). Thereby this project will contribute to the knowledge of treatment of patients with FMS. The effectiveness of the intervention will be expressed in terms of a) reduced pain, b) psychometric outcomes, c) quality of life, d) improved engagement in daily activities and e) prevented transition to chronic disability. We furthermore aim to 1) determine the effectiveness of providing regular situational feedback in enhancing self-management and, consequently 2) study the effectiveness of enhancing self-management in reducing pain and physical disability.
Self-management of chronic pain is increasingly seen as an important tool in providing adequate care to patients with FMS and other types of Chronic Non-malignant Pain. Enhancing the patient's self-management of her/his condition is thought to be effective in reducing pain and disability. However, sufficient empirical evidence to support this is yet unavailable. This may be due to the non-situational nature of many interventions studied so far: Patients are taught management skills in a clinical setting, and may not be able to successfully use these skills in daily care. Therefore, enhancing self-management of chronic pain, by providing immediate feedback that is directly related to patient's daily life ("situational" feedback) complementary to care-as usual, is thought to be more effective than conventional interventions in a clinical setting. This may even be even more effective when the patient receives quick response feedback using mobile communication technology, i.e. any place any time.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Other: Webpage Other: Webpage and situation feedback |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback |
- Change in catastrophizing cognitions [ Time Frame: T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1 ] [ Designated as safety issue: No ]PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).
- Change in acceptance [ Time Frame: T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1 ] [ Designated as safety issue: No ]CPAQ: Chronic Pain Acceptance questionnaire (McCracken)
| Enrollment: | 140 |
| Study Start Date: | March 2009 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: web page
Control group: Information web page with some mindfulness exercises |
Other: Webpage
one arm having access to a webpage with information about coping with pain and relaxation exercises
Other Name: Information web page with some mindfulness exercises
|
|
Experimental: Webpage and situational feedback
Intervention group: have access to the same web-page with information about coping with pain and relaxation and are completing 3 diaries and receiving personalized feedback for 4 weeks at home through a smartphone. |
Other: Webpage and situation feedback
having access to the same web-page with information about coping with pain and relaxation relaxation and completing 3 diaries and receiving situational feedback for 4 weeks at home through a web enabled mobile phone.
Other Name: Intervention group
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female, having wide spread pain like FMS (IPCS codes CD-10, 79.0 - coded) for at least three months ,> 18 years, able to understand Norwegian; able to use the webenabled mobile phone.
Exclusion Criteria:
- substantial psychological problems in need of treatment with intensive psychotherapy.
Contacts and Locations| Norway | |
| Jeloy kurbad rehabilitation centre | |
| Moss, Norway, 1517 | |
| Principal Investigator: | Hilde Eide, PhD | Buskerud University College |
More Information
No publications provided by Oslo University College
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Inger Johanne Flatland, Research advisor, Oslo University College |
| ClinicalTrials.gov Identifier: | NCT01236209 History of Changes |
| Other Study ID Numbers: | 182014/V50 |
| Study First Received: | November 5, 2010 |
| Last Updated: | May 8, 2013 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013