Feasibility of a Life Coping Program: A Study Protocol (LifeCOPE)

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Pediatric ALL; Health Literacy; Health Related Quality of Life
• Intervention / Treatment: Behavioral: Life Coping Program

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5009
      • Haukeland university hospital - Department of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; In this feasability study following established clinical practice, all participants are included in the intervention Life Coping Program.

Behavioral: Life 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Checklist for health personnel	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; Primary digital consultation,; primary individual consultation during the Life Coping Course,; Activities during the Life Coping Course, and; The digital follow-up consultation 3-4 weeks after.	Immediately after the procedures
Proportion of completed components	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.	From enrollment to 6 months after the 5-day Life Coping Course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related Quality of Life	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.	From enrollment to 3-4 weeks and 6 months after the 5-days Life Coping Course
Activity Levels	Objective activity levels will be measured using ActiGraph GT3X+-monitors following a standardized protocol of seven consecutive days of measuring.	From enrollment to 6 months after the 5-days Life Coping Course
Self-reported activity levels and satisfaction with relevant activities	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".	From enrollment to 3-4 weeks and 6 months after the five-day Life Coping Course.
Evaluation of the Life Coping Course	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	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen; Western Norway University of Applied Sciences
• Investigators: Principal Investigator: Mette Engan, MD PhD, Haukeland University Hospital

Publications and helpful links

Helpful Links

• (NORWEGIAN) Brief description of the intervention Life Coping Program, as presented to the public
• (NORWEGIAN) Open part of the digital portal

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 578213; Recruitment PhD (Other Grant/Funding Number: University of Bergen, Deparment of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No