Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Webpage
Webpage and situation feedback
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia
Eligibility Criteria
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.
Sites / Locations
- Jeloy kurbad rehabilitation centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
web page
Webpage and situational feedback
Arm Description
Control group: Information web page with some mindfulness exercises
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.
Outcomes
Primary Outcome Measures
Change in catastrophizing cognitions
PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).
Secondary Outcome Measures
Change in acceptance
CPAQ: Chronic Pain Acceptance questionnaire (McCracken)
Full Information
NCT ID
NCT01236209
First Posted
November 5, 2010
Last Updated
May 5, 2017
Sponsor
Oslo Metropolitan University
Collaborators
The Research Council of Norway, St. Olavs Hospital, Netherlands Instititute for Health Services Research, Buskerud University College
1. Study Identification
Unique Protocol Identification Number
NCT01236209
Brief Title
Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
Official Title
Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo Metropolitan University
Collaborators
The Research Council of Norway, St. Olavs Hospital, Netherlands Instititute for Health Services Research, Buskerud University College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
web page
Arm Type
Active Comparator
Arm Description
Control group:
Information web page with some mindfulness exercises
Arm Title
Webpage and situational feedback
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Webpage
Other Intervention Name(s)
Information web page with some mindfulness exercises
Intervention Description
one arm having access to a webpage with information about coping with pain and relaxation exercises
Intervention Type
Other
Intervention Name(s)
Webpage and situation feedback
Other Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in catastrophizing cognitions
Description
PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).
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
Secondary Outcome Measure Information:
Title
Change in acceptance
Description
CPAQ: Chronic Pain Acceptance questionnaire (McCracken)
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Eide, PhD
Organizational Affiliation
Buskerud University College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeloy kurbad rehabilitation centre
City
Moss
ZIP/Postal Code
1517
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27541314
Citation
Nes AA, van Dulmen S, Wicksell R, Fors EA, Eide H. Analyzing Change Processes Resulting from a Smartphone Maintenance Intervention Based on Acceptance and Commitment Therapy for Women with Chronic Widespread Pain. Int J Behav Med. 2017 Apr;24(2):215-229. doi: 10.1007/s12529-016-9590-7.
Results Reference
background
PubMed Identifier
23433735
Citation
Nes AA, Eide H, Kristjansdottir OB, van Dulmen S. Web-based, self-management enhancing interventions with e-diaries and personalized feedback for persons with chronic illness: a tale of three studies. Patient Educ Couns. 2013 Dec;93(3):451-8. doi: 10.1016/j.pec.2013.01.022. Epub 2013 Feb 21.
Results Reference
background
PubMed Identifier
24132549
Citation
Smedslund G, Eide H, Kristjansdottir OB, Nes AA, Sexton H, Fors EA. Do weather changes influence pain levels in women with fibromyalgia, and can psychosocial variables moderate these influences? Int J Biometeorol. 2014 Sep;58(7):1451-7. doi: 10.1007/s00484-013-0747-7. Epub 2013 Oct 17.
Results Reference
background
PubMed Identifier
23538392
Citation
Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. J Med Internet Res. 2013 Mar 28;15(3):e72. doi: 10.2196/jmir.2442.
Results Reference
derived
PubMed Identifier
23291270
Citation
Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist-feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain: randomized controlled trial. J Med Internet Res. 2013 Jan 7;15(1):e5. doi: 10.2196/jmir.2249.
Results Reference
derived
PubMed Identifier
21352516
Citation
Kristjansdottir OB, Fors EA, Eide E, Finset A, van Dulmen S, Wigers SH, Eide H. Written online situational feedback via mobile phone to support self-management of chronic widespread pain: a usability study of a Web-based intervention. BMC Musculoskelet Disord. 2011 Feb 25;12:51. doi: 10.1186/1471-2474-12-51.
Results Reference
derived
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Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
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