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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Moss, Noorwegen, 1517
- Jeloy kurbad rehabilitation centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: web page
Control group: Information web page with some mindfulness exercises |
one arm having access to a webpage with information about coping with pain and relaxation exercises
Andere namen:
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Experimenteel: 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. |
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in catastrophizing cognitions
Tijdsspanne: 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
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PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in acceptance
Tijdsspanne: 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
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CPAQ: Chronic Pain Acceptance questionnaire (McCracken)
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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
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Hilde Eide, PhD, Buskerud University College
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 182014/V50
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