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

Oslo Metropolitan University

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Webpage; Other: Webpage and situation feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT01236209

182014/V50

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

web page

Active Comparator group

Description:

Control group: Information web page with some mindfulness exercises

Treatment:

Other: Webpage

Webpage and situational feedback

Experimental group

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.

Treatment:

Other: Webpage and situation feedback