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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01236209
Enrollment
140
Registered
2010-11-08
Start date
2009-03-31
Completion date
2013-01-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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.

Interventions

OTHERWebpage

one arm having access to a webpage with information about coping with pain and relaxation exercises

OTHERWebpage 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.

Sponsors

The Research Council of Norway
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
Netherlands Instititute for Health Services Research
CollaboratorOTHER
Buskerud University College
CollaboratorUNKNOWN
Oslo Metropolitan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in catastrophizing cognitionsT1: 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 T1PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).

Secondary

MeasureTime frameDescription
Change in acceptanceT1: 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 T1CPAQ: Chronic Pain Acceptance questionnaire (McCracken)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026