Feasibility of a Life Coping Program: a Study Protocol

Last updated: November 27, 2024
Sponsor: Haukeland University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Treatment

Life Coping Program

Clinical Study ID

NCT06709248
578213
Recruitment PhD
  • Ages 8-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofcancer treatment, chronic pain conditions, or significant burn injuries

  • Must be able to answer questionnaires in Norwegian

Exclusion

Exclusion Criteria:

  • Medical condition that may hinder og alter participation

  • Treatment plan that may hinder or alter participation

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Life Coping Program
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Haukeland university hospital - Department of Pediatrics

    Bergen, Vestland 5009
    Norway

    Active - Recruiting

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