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Health LiteracyLifeCOPENCT06709248

Feasibility of a Life Coping Program: A Study Protocol

A study testing Life Coping Program in people with Health Literacy and Health Related Quality of Life, run by Haukeland University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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?… Read more about this study

Who is it for?
Ages 8 to 16 years
What is being tested?
Life Coping Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteNorway
Study dates
1 May 2023to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland university hospital - Department of Pediatrics

    Bergen, Vestland, 5009

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Life Coping Program
Medical subject headings
Motor Activity, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Life Coping ProgramBehavioural

    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.

Study groups in NCT06709248
Study groupRoleWhat they receive
InterventionExperimentalIn this feasability study following established clinical practice, all participants are included in the intervention Life Coping Program.
Receives: Behavioral: Life Coping Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to 6 months after the 5-day Life Coping Course

  2. 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;

    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.

    Measured: Immediately after the procedures

Secondary outcomes (4)

  1. 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

    Measured: Immediately after the procedure

  2. 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.

    Measured: From enrollment to 3-4 weeks and 6 months after the 5-days Life Coping Course

  3. Activity Levels

    Objective activity levels will be measured using ActiGraph GT3X+-monitors following a standardized protocol of seven consecutive days of measuring.

    Measured: From enrollment to 6 months after the 5-days Life Coping Course

  4. 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".

    Measured: From enrollment to 3-4 weeks and 6 months after the five-day Life Coping Course.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start1 May 2023
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709248
Sponsor's protocol ID
578213
Other IDs
Recruitment PhD
Acronym
LifeCOPE
Status last verified
Nov 2024
First submitted
25 Nov 2024
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bovim LPV, Rotevatn EO, Kvidaland HK, Bogen B, Halvorsen T, Engan M. 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. Pilot Feasibility Stud. 2025 Jul 17;11(1):101. doi: 10.1186/s40814-025-01682-w.

    PubMed 40676648

Questions about this trial

What is this clinical trial studying?

A study testing Life Coping Program in people with Health Literacy and Health Related Quality of Life, run by Haukeland University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of completed components (time frame: From enrollment to 6 months after the 5-day Life Coping Course). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06709248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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