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01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Musculoskeletal Disorders 1/2015

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

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2015
Autoren:
Victoria Carmona-Terés, Iris Lumillo-Gutiérrez, Lina Jodar-Fernández, Teresa Rodriguez-Blanco, Joanna Moix-Queraltó, Enriqueta Pujol-Ribera, Xavier Mas, Enrique Batlle-Gualda, Milena Gobbo-Montoya, Anna Berenguera
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

AB, EP, JM, TR and VC contributed to the conception and design and methodology of the study. AB is the scientific director of the project. VC designed the intervention. VC and AB developed the draft manuscript. IL, LJ and XM are part of the clinical team and have contributed to adapting the protocol to clinical practice. TR provided the statistics of the study. All authors read and approved the final manuscript.

Authors’ information

AB, EP and TR– Primary Health Care University Research Institute-IDIAP Jordi Gol.
EB – University Hospital Sant Joan, Alacant.
JM and VC – Universitat Autònoma de Barcelona (UAB).
MG- Psicología del dolor y enfermedades reumáticas.
IL, LJ and XM – Catalan Institute of Health (ICS).

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.
Literatur
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