Efficacy of a Psychoeducative Program for Improving Quality of Life in Fibromyalgic Patients [Study Protocol]

NCT00550966 | Unknown

• 1 other identifier: 077/25/2006
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This research project pretends to demonstrate that a psychoeducative program implemented in the context of PC can produce a significant increase in the quality of life of patients with FM, as well as a decrease in the use of sanitary and social services, compared to usual care.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Quality of life; Primary Care; Non-pharmacological treatment; Cost / Cost-efficacy

Outcome Measures

Primary Outcomes (1)

• Quality of life is measured with the FIQ and the EuroQol-5D.

  1, 2, 6 and 12 months later

Secondary Outcomes (1)

• The use of sanitary services is measured with an adapted version of the Client Service Receipt Inventory (CSRI)

  1, 2, 6 and 12 months later

Study Arms (1)

1

ACTIVE COMPARATOR

Randomized controlled trial with a 12-month follow-up involving two groups, one of which is the intervention group that includes patients receiving a psychoeducative program and the other is the control group formed by patients treated for FM in the usual way. Setting. Three urban PC centers in the province of Barcelona (Spain) Sample. The total sample comprises 218 patients (over 18 years of age) suffering FM, selected from a database (Rheumatology service-Viladecans hospital) of patients with this illness. Only those patients introduced in the database between the years 2005 and 2007 are included in the selection. Selected patients are asked for written informed consent to participate in the study.

Behavioral: Psychoeducative program in fibromyalgic patients

Interventions

Psychoeducative program in fibromyalgic patients BEHAVIORAL

Multi-component program including information about the illness, counselling about physical exercise and training in autogenic relaxation. The intervention consists on nine 2 hour sessions delivered during a two month period. The pharmacological treatment prescribed by the physician is maintained in both groups.

Also known as: Fibromyalgia, Psychoeducative program

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)

You may not qualify if:

• Patients with a diagnosis not based on the ACR criteria
• Those with cognitive impairment or suffering from physical mental/psychiatric limitations
• Severe concurrent rheumatologic illness that impede participation in the study evaluations
• Those who are not expected to live at least 12 months
• Those without schooling.

Sponsors & Collaborators

• Institut Catala de Salut: lead
• Agència d'Avaluació de Tecnologia i Recerca Mèdiques: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator

Study Sites (1)

ABS Bartomeu Fabres Anglada. Institut Català de Salut.

Gavà, Barcelona, 08850, Spain

Location

Related Publications (2)

• Luciano JV, Sabes-Figuera R, Cardenosa E, T Penarrubia-Maria M, Fernandez-Vergel R, Garcia-Campayo J, Knapp M, Serrano-Blanco A. Cost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trial. Clin J Pain. 2013 Aug;29(8):702-11. doi: 10.1097/AJP.0b013e318270f99a.

  PMID: 23328339 DERIVED

• Luciano JV, Martinez N, Penarrubia-Maria MT, Fernandez-Vergel R, Garcia-Campayo J, Verduras C, Blanco ME, Jimenez M, Ruiz JM, Lopez del Hoyo Y, Serrano-Blanco A; FibroQoL Study Group. Effectiveness of a psychoeducational treatment program implemented in general practice for fibromyalgia patients: a randomized controlled trial. Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.

  PMID: 21317775 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Rita Fernández-Vergel, Doctor

  Institut Català de Salut (ICS)

  PRINCIPAL INVESTIGATOR

• María Teresa Peñarrubia, Doctor

  Institut Català de Salut (ICS)

  STUDY DIRECTOR

• Elena Blanco, Doctor

  ICS

  STUDY CHAIR

• Mónica Jiménez, Doctor

  ICS

  STUDY CHAIR

• Adrián Montesano, psychology

  Fundació Jordi Gol i Gurina. ICS

  STUDY DIRECTOR

• Antonio Serrano, psychiatrist

  Sant Joan de Déu-Serveis de Salut Mental

  STUDY DIRECTOR

• Juan Vicente Luciano, psychology

  Red de Investigación en Actividades Preventivas y Promoción de la Salud en Atención Primaria (RedIAPP)

  STUDY CHAIR

• Mª del Camino Verduras, Doctor

  ICS

  STUDY CHAIR

• José Miguel Ruíz, Reumatology

  ICS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: September 1, 2007
• Study Completion: February 1, 2010
• Last Updated: October 30, 2007

Record last verified: 2007-09

Locations

ES (1)