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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2010

Last Updated Date

May 8, 2013

Start Date ^ICMJE

March 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

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).

Change History

Complete list of historical versions of study NCT01236209 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

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)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: web page
Control group:

Information web page with some mindfulness exercises

Intervention: Other: Webpage
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.

Intervention: Other: Webpage and situation feedback

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

January 2013

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01236209

Other Study ID Numbers ^ICMJE

182014/V50

Has Data Monitoring Committee

Yes

Responsible Party

Inger Johanne Flatland, Oslo University College

Study Sponsor ^ICMJE

Inger Johanne Flatland

Collaborators ^ICMJE

The Research Council of Norway
St. Olavs Hospital
Netherlands Instititute for Health Services Research
Buskerud University College

Investigators ^ICMJE

Principal Investigator:

Hilde Eide, PhD

Buskerud University College

Information Provided By

Oslo University College

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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