Clinical trial NCT06709248: Feasibility of a Life Coping Program: A Study Protocol
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Health Related Quality of Life
Physical Activity
Pediatric ALL
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Western Norway University of Applied Sciences
First posted: 2024-11-29
Enrollment: 54
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this observational study is to evaluate the feasibility of the intervention Life Coping Program in children and adolescents 8-16 years of age. The main question it aims to answer is:

Is the Life Coping Program in its current form feasible among children and adolescents with a variety of primary conditions?

The health care providers of participants already undergoing the Life Coping Program will answer survey questions after key procedures of the intervention, and the research team will be given access to measures provided by the participants.

Detailed description: Feasibility and acceptability of the intervention Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children or adolescents with chronic illness or severe medical condition will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in different parts of the intervention. Acceptability of the intervention will be assessed using patient reported experience measures (PREM). Health related quality of life (HrQoL) and level of physical activity will be measured using the Kidscreen 27 and Actigraph GT3X+ monitor, respectively, at baseline and post-intervention.

The study is based on the British Medical Research Council's (MRC) framework for developing and evaluating complex interventions, and will explore innovative treatment strategies that could potentially improve current clinical outcomes and reduce the need for ongoing healthcare follow-up. The findings from this feasibility study will lay the groundwork for a future definitive randomized controlled trial in accordance with the MRC framework for developing and evaluating complex interventions.

Eligibility criteria: Inclusion Criteria:

* Have received treatment at Haukeland University Hospital
* One or more of the following primary conditions: congenital heart defects, congenital oral clefts, premature birth before 32 weeks of gestation, completion of cancer treatment, chronic pain conditions, or significant burn injuries
* Must be able to answer questionnaires in Norwegian

Exclusion Criteria:

* Medical condition that may hinder og alter participation
* Treatment plan that may hinder or alter participation

Primary outcomes:
measure: Proportion of completed components
timeFrame: From enrollment to 6 months after the 5-day Life Coping Course
measure: Checklist for health personnel
timeFrame: Immediately after the procedures
Secondary outcomes:
measure: Evaluation of the Life Coping Course
timeFrame: Immediately after the procedure
measure: Health related Quality of Life
timeFrame: From enrollment to 3-4 weeks and 6 months after the 5-days Life Coping Course
measure: Activity Levels
timeFrame: From enrollment to 6 months after the 5-days Life Coping Course
measure: Self-reported activity levels and satisfaction with relevant activities
timeFrame: From enrollment to 3-4 weeks and 6 months after the five-day Life Coping Course.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland university hospital - Department of Pediatrics
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Mette Engan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: