Health Literacy, Health Related Quality of Life, Pediatric ALL, Physical Activity
Conditions
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.
Interventions
BEHAVIORALLife Coping Program
The Life Coping Program is built around a coordinated 5-day Life Coping Course. Participants included are grouped by their primary condition, meaning the diagnosis or illness reasoning the referral. Each family is assigned a dedicated Primary Contact throughout the program, and the program consists of three phases: Phase 1: Preparation - Written/visual materials and questionnaires are provided to motivate and inform. A digital consultation occurs 3-5 weeks before the Life Coping Course, covering goals, commitment, and follow-up. Materials are offered in paper or digital formats. Phase 2: Life Coping Course - The 5-day course includes individual consultations, group activities, education, and medical follow-ups, focusing on coping strategies and well-being. Phase 3: Implementation - A summary meeting is conducted, including key persons for further implementation in own local area. Digital follow-ups at 3-4 weeks and 6 months post course assess progress and guide goal achievement.
Sponsors
University of Bergen
Western Norway University of Applied Sciences
Haukeland University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of completed components | From enrollment to 6 months after the 5-day Life Coping Course | The proportion of completed components of the Life Coping Program per participant, as reported on checklists completed by health personnel, fully completed questionnaires by participants, and successful use of activity monitors. |
| Checklist for health personnel | Immediately after the procedures | Based on the work of Bellg et al. (2004) and Husted et al. (2014), purpose-built checklists are designed for four pre-defined key procedures of the intervention; 1. Primary digital consultation, 2. primary individual consultation during the Life Coping Course, 3. Activities during the Life Coping Course, and 4. The digital follow-up consultation 3-4 weeks after. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Life Coping Course | Immediately after the procedure | A purpose-design evaluation form aiming to assess adolescent and caregivers' experiences and acceptance of phase 2: the five-day Life Coping Course. The questionnaire covers practical aspects, perceived relevance of the activities, interactions with healthcare staff, and overall alignment with their life situation |
| Health related Quality of Life | From enrollment to 3-4 weeks and 6 months after the 5-days Life Coping Course | The standardised and valid questionnaire KidScreen27 will be used. Both the version for children and adolescents and the version for parents will be implemented in the study. |
| Activity Levels | From enrollment to 6 months after the 5-days Life Coping Course | Objective activity levels will be measured using ActiGraph GT3X+-monitors following a standardized protocol of seven consecutive days of measuring. |
| Self-reported activity levels and satisfaction with relevant activities | From enrollment to 3-4 weeks and 6 months after the five-day Life Coping Course. | A purpose-made questionnaire aiming on investigating the child or adolescents relations to physical activity. The questionnaire is partly based on the WHO-survey Health Behavior in School-Aged Children. |
Countries
Norway
Outcome results
None listed