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.

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.

Clinicaltrials: gov, NCT06709248. Registered 15th of November 2024-retrospectively registered, https://clinicaltrials.gov/study/NCT06709248?term=NCT06709248&rank=1.