Feasibility of a Life Coping Program: a Study Protocol

Not Applicable

Recruiting

• Conditions: Health Literacy; Health Related Quality of Life; Physical Activity; Pediatric ALL

• Registration Number: NCT06709248
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
Evaluation form for 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.

Secondary Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

Haukeland university hospital - Department of Pediatrics; 🇳🇴 Bergen, Vestland, Norway