title: Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.
abstract: BACKGROUND
  The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis.
  
  
  METHODS
  Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial.
  
  
  METHODS
  360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions.
  
  
  METHODS
  will receive standard care.
  
  
  METHODS
  quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1.
  
  
  CONCLUSIONS
  If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care.
  
  
  BACKGROUND
  ISRCTN57405925. Registred 20 June 2014.
authors.affiliation: Departamento de Psicología Básica, Universitat Autònoma de Barcelona; Facultad de Psicología, evolutiva y de la Salud. Edificio B. Campus de la UAB, Bellaterra, 08193, Barcelona, Spain. victoriacarmona@copc.cat.
authors.forename: Victoria
authors.initials: V
authors.lastname: Carmona-Terés
authors.affiliation: Centro Atención Primaria Can Bou, Calle Ciutat de Màlaga, 18-20, Castelldefels, 08860, Barcelona, Spain. irislumillo@gmail.com.
authors.forename: Iris
authors.initials: I
authors.lastname: Lumillo-Gutiérrez
authors.affiliation: Centro Atención Primaria Sant Ildefons, Avda República Argentiana s/n, Cornellà de Llobregat, 08940, Barcelona, Spain. ljodar74@gmail.com.
authors.forename: Lina
authors.initials: L
authors.lastname: Jodar-Fernández
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol), Gran Via Corts Catalanes, 587, àtic, Barcelona, 08007, Spain. trodriguez@idiapjgol.org.|Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain. trodriguez@idiapjgol.org.
authors.forename: Teresa
authors.initials: T
authors.lastname: Rodriguez-Blanco
authors.affiliation: Departamento de Psicología Básica, Universitat Autònoma de Barcelona; Facultad de Psicología, evolutiva y de la Salud. Edificio B. Campus de la UAB, Bellaterra, 08193, Barcelona, Spain. jenny.moix@uab.cat.
authors.forename: Joanna
authors.initials: J
authors.lastname: Moix-Queraltó
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol), Gran Via Corts Catalanes, 587, àtic, Barcelona, 08007, Spain. epujol@idiapjgol.org.|Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain. epujol@idiapjgol.org.
authors.forename: Enriqueta
authors.initials: E
authors.lastname: Pujol-Ribera
authors.affiliation: Centro de Atención Primaria Amadeu Torner, Calle Amadeu Torner, 63, l'Hospitalet de Llobregat, 08902, Barcelona, Spain. 22716xmg@comb.cat.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mas
authors.affiliation: Hospital Universitario de San Juan de Alicante; Unidad de Reumatología, Ctra N-332, Sant Joan d'Alacant, Alicante-Valencia, 03550, Spain. batlle_enr@gva.es.
authors.forename: Enrique
authors.initials: E
authors.lastname: Batlle-Gualda
authors.affiliation: Psicología del dolor y en enfermedades reumáticas, Av. Presidente Carmona, 10 bis 1ºA, Madrid, 28020, Spain. milena.gobbo@ser.es.
authors.forename: Milena
authors.initials: M
authors.lastname: Gobbo-Montoya
authors.affiliation: Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol), Gran Via Corts Catalanes, 587, àtic, Barcelona, 08007, Spain. aberenguera@idiapjgol.org.|Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain. aberenguera@idiapjgol.org.
authors.forename: Anna
authors.initials: A
authors.lastname: Berenguera
mesh_terms: D018771:Arthralgia / Q000191:economics / Q000628:therapy; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics*; D004032:Diet; D015444:Exercise; D005260:Female; D015438:Health Behavior; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000191:economics* / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010353:Patient Education as Topic / Q000191:economics*; D011320:Primary Health Care / Q000191:economics; D036301:Qualitative Research; D011788:Quality of Life; D012107:Research Design; D040242:Risk Reduction Behavior; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss