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Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
St. Olavs Hospital
Netherlands Instititute for Health Services Research
Buskerud University College
Information provided by (Responsible Party):
Inger Johanne Flatland, Oslo University College
ClinicalTrials.gov Identifier:
NCT01236209
First received: November 5, 2010
Last updated: May 8, 2013
Last verified: May 2013

November 5, 2010
May 8, 2013
March 2009
July 2010   (final data collection date for primary outcome measure)
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).
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).
Complete list of historical versions of study NCT01236209 on ClinicalTrials.gov Archive Site
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)
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)
Not Provided
Not Provided
 
Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Fibromyalgia
  • 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
  • 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
  • Active Comparator: web page

    Control group:

    Information web page with some mindfulness exercises

    Intervention: Other: Webpage
  • 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.

    Intervention: Other: Webpage and situation feedback

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
January 2013
July 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01236209
182014/V50
Yes
Inger Johanne Flatland, Oslo University College
Inger Johanne Flatland
  • The Research Council of Norway
  • St. Olavs Hospital
  • Netherlands Instititute for Health Services Research
  • Buskerud University College
Principal Investigator: Hilde Eide, PhD Buskerud University College
Oslo University College
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP