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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/Design  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.  Participants : 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.  Control Group : will receive standard care.  Main Outcome Variable : 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.    Discussion  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.    Trial registration   ISRCTN57405925 . Registred 20 June 2014.

bmc musculoskeletal disorders

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial