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

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
St. Olavs Hospital
Netherlands Instititute for Health Services Research
Buskerud University College
Information provided by (Responsible Party):
Inger Johanne Flatland, Oslo University College
ClinicalTrials.gov Identifier:
NCT01236209
First received: November 5, 2010
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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 Intervention
Fibromyalgia
Other: Webpage
Other: Webpage and situation feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback

Resource links provided by NLM:


Further study details as provided by Oslo University College:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    PCS: Pain Catastrophizing Scale (Sullivan et al., 1995).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    CPAQ: Chronic Pain Acceptance questionnaire (McCracken)


Enrollment: 140
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236209

Locations
Norway
Jeloy kurbad rehabilitation centre
Moss, Norway, 1517
Sponsors and Collaborators
Inger Johanne Flatland
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

No publications provided by Oslo University College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Inger Johanne Flatland, Research advisor, Oslo University College
ClinicalTrials.gov Identifier: NCT01236209     History of Changes
Other Study ID Numbers: 182014/V50
Study First Received: November 5, 2010
Last Updated: May 8, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014