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/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.