Feasibility of a group-based intervention to enhance health-related quality of life and physical activity in children and adolescents with chronic illness: a study protocol.
Lars Peder Vatshelle Bovim, Elisabeth Ørskov Rotevatn, Haakon Kristian Kvidaland, Bård Bogen, Thomas Halvorsen, Mette Engan
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引用次数: 0
Abstract
Background: Chronic or long-term illnesses in early years increase the risk of comorbidities such as mental disorders, social exclusion, and difficulties in forming relationships. In Bergen, Norway, the three-phased intervention Life Coping Program is established. This program is designed to support adolescents with chronic or long-term illnesses through tailored preparation, a hospital-based Life Coping Course, and structured follow-up aimed at empowering them to actively manage their health and adopt a more active lifestyle. This protocol paper describes a feasibility trial of the Life Coping Program, focused on improved health-related quality of life (HRQoL) and levels of physical activity.
Methods/design: This study is based on the British Medical Research Council's (MRC) modified framework for developing and evaluating complex interventions. Feasibility and acceptability of the Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children and adolescents with chronic illness or severe medical conditions will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in the different parts of the intervention. Acceptability of the intervention will be assessed by patient-reported questionnaires. HRQoL and levels of physical activity will be measured using the KidScreen-27 and Actigraph GT3X + monitor, respectively, at baseline and 1 and 6 months post-intervention.
Discussion: The study will explore the feasibility of an innovative treatment strategy targeting children and adolescents at risk of poor health-related outcomes across multiple dimensions. The findings will inform the design of a future randomized controlled trial.
Trial registration:
Clinicaltrials: gov, NCT06709248. Registered 15th of November 2024-retrospectively registered, https://clinicaltrials.gov/study/NCT06709248?term=NCT06709248&rank=1.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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