Adherence-strong for juvenile arthritis

描述(由申请人提供)：这项R21试点研究是一项随机对照试验(RCT)，旨在为青少年关节炎(JA)儿童的父母提供创新的教育和行为网络依从性促进计划。它将使我们能够系统地开发干预措施，并收集足够的试点数据，以证明适当规模的随机临床试验是合理的。这项拟议的研究涉及国家关节炎和肌肉骨骼及皮肤疾病研究所(NIAMS)的行为和生物心理社会研究重点，特别是“关于非药物干预和综合干预的研究，包括开发和测试基于个人、群体和技术的干预措施，以加强自我管理和改善与健康相关的行为”[30]。不遵守药物治疗方案对患有慢性儿科疾病的儿童和青少年的健康和生活质量构成严重威胁[35]。患有JA的儿童及其父母通常被要求在很长一段时间内始终如一地坚持各种治疗方案，最明显的是药物、治疗性练习和关节夹板。这些方案中的许多可能具有延迟的有益效果，并且在短期内可能会引起不想要的副作用，如胃肠道刺激和疼痛。长期坚持治疗的需要、延迟的有益效果和负面副作用都是儿科慢性疾病中更严重的坚持问题的预测因素[35]。这项建议的主要目的是开发和试行“JA依从性强”计划，该计划旨在帮助父母提高他们的孩子对JA药物治疗方案的依从性，包括药物、治疗性锻炼和关节夹板。在与4至6名家长一起开发和测试该计划后，我们将进行一项试点研究，将患有JA儿童的父母随机分配到依从性强计划或等待名单对照中。依从性(电子监测和父母评分)和生活质量的测量将在基线、治疗后立即和3个月的随访中获得。假设是，与父母被分配到等待名单控制组的孩子相比，父母接受依从性强计划的孩子将表现出更高的依从性和生活质量。如果这项试点研究成功，将提出一个更大的多站点R01随机对照试验，以进一步验证坚持性强的计划。 公共卫生相关性：这项R21试点研究是一项随机对照试验(RCT)，旨在为青少年关节炎(JA)儿童的父母提供创新的教育和行为网络依从性促进计划。它将使我们能够系统地开发干预措施，并收集足够的试点数据，以证明适当规模的随机临床试验是合理的。

DESCRIPTION (provided by applicant): This R21 pilot study is a randomized controlled trial (RCT) of an innovative educational and behavioral web-based adherence promotion program for parents of children with juvenile arthritis (JA). It will allow us to systematically develop the intervention and to collect sufficient pilot data to justify a suitably large randomized clinical trial. The proposed study addresses behavioral and biopsychosocial research priorities of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), specifically "studies on non- pharmacological interventions and combined interventions, including development and testing of individual, group, and technology-based interventions to enhance self-management and improve health-related behaviors" [30].Nonadherence to medical regimens poses a significant threat to the health and quality of life of children and adolescents with chronic pediatric diseases [35]. Children with JA and their parents are usually asked to adhere consistently and over a long period of time to a variety of therapeutic regimens, most notably, medications, therapeutic exercises, and splinting of joints. Many of these regimens may have delayed beneficial effects and in the short term may cause unwanted side effects, such as gastrointestinal irritation and pain. The need for consistent adherence over a long period of time, delayed beneficial effects, and negative side effects have all been predictive factors of greater adherence problems in pediatric chronic diseases [35]. The primary aim of this proposal is to develop and pilot test "Adherence-Strong for JA", a program designed to help parents enhance their children's adherence to medical regimens for JA, including medications, therapeutic exercise, and splinting of joints. After developing and testing the program with 4 to 6 parents, we will conduct a pilot study wherein 64 parents of children with JA will be randomly assigned to the Adherence-strong program or a wait-list control. Measures of adherence (electronic monitoring and parent ratings) and quality of life will be obtained at baseline, immediate post-treatment and 3-month follow-up. Hypotheses are that children whose parents receive the Adherence-strong program will demonstrate higher adherence and quality of life compared to children whose parents were assigned to the wait-list control group. If this pilot study is successful, a larger multi-site R01 RCT will be proposed to further validate the Adherence-strong program. PUBLIC HEALTH RELEVANCE: This R21 pilot study is a randomized controlled trial (RCT) of an innovative educational and behavioral web- based adherence promotion program for parents of children with juvenile arthritis (JA). It will allow us to systematically develop the intervention and to collect sufficient pilot data to justify a suitably large randomized clinical trial.