Adherence-strong for juvenile arthritis

对幼年关节炎具有很强的依从性

• 批准号: 7989069
• 负责人: MICHAEL Andrew RAPOFF
• 金额: $ 16.88万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-08 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7989069
• 关键词: 7 year old; Address; Adherence; Adolescent; Adverse effects; Aftercare; Age; Behavior; Behavioral; CD-ROM; Caring; Child; Childhood; Chronic; Chronic Childhood Arthritis; Chronic Disease; Chronic Headaches; Control Groups; Data; Development; Disease; Electronics; Exercise; Funding; Future; Generic Drugs; Grant; Health; Individual; Intervention; Joints; Kansas; Lead; Measures; Medical; Medical center; Minimal Contact Treatment; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Online Systems; Pain; Parents; Participant; Pharmaceutical Preparations; Pilot Projects; Predictive Factor; Principal Investigator; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Research; Research Priority; Self Management; Site; Splint Device; Study Section; Technology; Testing; Therapeutic; Time; Universities; Waiting Lists; base; biopsychosocial; chronic abdominal pain; design; follow-up; gastrointestinal; improved; innovation; irritation; parental monitoring; programs; public health relevance

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.

描述（由申请人提供）：这项R21试点研究是一项针对青少年关节炎（JA）儿童父母的创新教育和行为网络依从性促进计划的随机对照试验（RCT）。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，以证明一个适当的大型随机临床试验。拟议的研究解决了国家关节炎、肌肉骨骼和皮肤疾病研究所（NIAMS）的行为和生物心理社会研究优先事项，特别是“关于非药物干预和联合干预的研究，包括个体、群体、和基于技术的干预措施，以加强自我管理和改善与健康相关的行为”[30]不坚持药物治疗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重大威胁[35]。患有JA的儿童及其父母通常被要求长期坚持各种治疗方案，最值得注意的是药物，治疗练习和关节夹板。这些方案中的许多方案可能具有延迟的有益效果，并且在短期内可能导致不必要的副作用，例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大依从性问题的预测因素[35]。该提案的主要目的是开发和试点测试“JA坚持性强”，这是一个旨在帮助父母提高孩子对JA医疗方案的坚持性的计划，包括药物治疗，治疗性运动和关节夹板。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，其中64名JA儿童的家长将被随机分配到坚持性强的计划或等待名单对照。将在基线、治疗后即刻和3个月随访时获得依从性（电子监测和父母评级）和生活质量指标。假设是，与父母被分配到等待名单对照组的儿童相比，父母接受坚持性强计划的儿童将表现出更高的坚持性和生活质量。如果该初步研究成功，将提出一项更大规模的多中心R01 RCT，以进一步验证强依从性项目。 公共卫生关系：这项R21试点研究是一项针对青少年关节炎（JA）儿童父母的创新教育和行为网络依从性促进计划的随机对照试验（RCT）。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，以证明一个适当的大型随机临床试验。