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

• ClinicalTrials.gov Identifier: NCT01236209
• Recruitment Status: Completed
• First Posted: November 7, 2010
• Last Update Posted: May 9, 2017
• Sponsor: Oslo Metropolitan University
• Collaborators: The Research Council of Norway; St. Olavs Hospital; Netherlands Instititute for Health Services Research; Buskerud University College
• Information provided by (Responsible Party): Oslo Metropolitan University

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: Webpage; Other: Webpage and situation feedback	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback
• Study Start Date: March 2009
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).

Secondary Outcome Measures :

1. 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 ]
   CPAQ: Chronic Pain Acceptance questionnaire (McCracken)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Norway

Jeloy kurbad rehabilitation centre

Moss, Norway, 1517

Sponsors and Collaborators

Oslo Metropolitan University

The Research Council of Norway

St. Olavs Hospital

Netherlands Instititute for Health Services Research

Buskerud University College

Investigators

• Principal Investigator: Hilde Eide, PhD; Buskerud University College

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Oslo Metropolitan University
• ClinicalTrials.gov Identifier: NCT01236209
• Other Study ID Numbers: 182014/V50
• First Posted: November 7, 2010
• Last Update Posted: May 9, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases