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基于小组干预改善慢性病儿童和青少年健康相关生活质量及身体活动的可行性:一项研究方案

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.

作者信息

Bovim Lars Peder Vatshelle, Rotevatn Elisabeth Ørskov, Kvidaland Haakon Kristian, Bogen Bård, Halvorsen Thomas, Engan Mette

机构信息

Children and Youth Clinic, Haukeland University Hospital, Bergen, Norway.

Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.

出版信息

Pilot Feasibility Stud. 2025 Jul 17;11(1):101. doi: 10.1186/s40814-025-01682-w.

Abstract

BACKGROUND

Chronic or long-term illnesses in early years increase the risk of comorbidities such as mental disorders, social exclusion, and difficulties in forming relationships. In Bergen, Norway, the three-phased intervention Life Coping Program is established. This program is designed to support adolescents with chronic or long-term illnesses through tailored preparation, a hospital-based Life Coping Course, and structured follow-up aimed at empowering them to actively manage their health and adopt a more active lifestyle. This protocol paper describes a feasibility trial of the Life Coping Program, focused on improved health-related quality of life (HRQoL) and levels of physical activity.

METHODS/DESIGN: This study is based on the British Medical Research Council's (MRC) modified framework for developing and evaluating complex interventions. Feasibility and acceptability of the Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children and adolescents with chronic illness or severe medical conditions will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in the different parts of the intervention. Acceptability of the intervention will be assessed by patient-reported questionnaires. HRQoL and levels of physical activity will be measured using the KidScreen-27 and Actigraph GT3X + monitor, respectively, at baseline and 1 and 6 months post-intervention.

DISCUSSION

The study will explore the feasibility of an innovative treatment strategy targeting children and adolescents at risk of poor health-related outcomes across multiple dimensions. The findings will inform the design of a future randomized controlled trial.

CLINICALTRIALS

gov, NCT06709248. Registered 15th of November 2024-retrospectively registered, https://clinicaltrials.gov/study/NCT06709248?term=NCT06709248&rank=1.

摘要

背景

早年的慢性或长期疾病会增加患精神障碍、社会排斥以及人际关系形成困难等合并症的风险。在挪威卑尔根,设立了三阶段干预的生活应对计划。该计划旨在通过量身定制的准备、以医院为基础的生活应对课程以及结构化的随访来支持患有慢性或长期疾病的青少年,旨在使他们有能力积极管理自己的健康并采取更积极的生活方式。本方案文件描述了生活应对计划的可行性试验,重点关注改善与健康相关的生活质量(HRQoL)和身体活动水平。

方法/设计:本研究基于英国医学研究理事会(MRC)用于开发和评估复杂干预措施的修改框架。生活应对计划的可行性和可接受性将在一项使用定量测量的非对照开放标签试验中进行评估。将招募60名患有慢性疾病或严重医疗状况的儿童和青少年以及一名相关照顾者。将通过跟踪干预不同部分的出勤和参与情况来评估可行性。将通过患者报告问卷评估干预的可接受性。将分别在基线以及干预后1个月和6个月使用儿童生活质量量表-27(KidScreen-27)和Actigraph GT3X+监测仪测量HRQoL和身体活动水平。

讨论

该研究将探索一种创新治疗策略的可行性,该策略针对在多个维度上存在健康相关不良后果风险的儿童和青少年。研究结果将为未来随机对照试验的设计提供信息。

临床试验

gov,NCT06709248。于2024年11月15日注册——追溯注册,https://clinicaltrials.gov/study/NCT06709248?term=NCT06709248&rank=1

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