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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236209
• Other study ID #: 182014/V50
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: May 5, 2017
• Start date: March 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2017
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Webpage
one arm having access to a webpage with information about coping with pain and relaxation exercises
• 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.

Locations

Country	Name	City	State
Norway	Jeloy kurbad rehabilitation centre	Moss

Sponsors (5)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences	Buskerud University College, Netherlands Instititute for Health Services Research, St. Olavs Hospital, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Nes AA, Eide H, Kristjánsdóttir ÓB, 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. — View 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. — View Citation

Smedslund G, Eide H, Kristjansdottir ÓB, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in catastrophizing cognitions	PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).	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	Change in acceptance	CPAQ: Chronic Pain Acceptance questionnaire (McCracken)	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