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Adherence-strong for juvenile arthritis

对幼年关节炎具有很强的依从性

基本信息

批准号：
8109194
负责人：
MICHAEL Andrew RAPOFF
金额：
$ 19.44万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-08 至 2013-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8109194
关键词：
7 year old Address Adherence Adolescent Adverse effects Aftercare Age Arthritis 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 Institutes Intervention Joints Kansas Lead Measures Medical Medical center Minimal Contact Treatment Musculoskeletal Diseases 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 skin disorder

项目摘要

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）：本R21试点研究是一项针对青少年关节炎（JA）患儿父母的创新教育和行为依从性促进计划的随机对照试验（RCT）。这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，以证明进行适当的大规模随机临床试验是合理的。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重点，特别是“非药物干预和联合干预的研究，包括个人、群体和基于技术的干预措施的开发和测试，以增强自我管理和改善与健康相关的行为”bbb。不遵守医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重大威胁[b]。患有JA的儿童和他们的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，治疗性运动和关节夹板。许多这些方案可能会延迟有益的效果，并在短期内可能会引起不必要的副作用，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的副作用都是儿童慢性疾病中更大的坚持问题的预测因素。该提案的主要目的是制定和试点“加强JA的依从性”方案，该方案旨在帮助父母提高孩子对JA医疗方案的依从性，包括药物治疗、治疗性运动和关节夹板。在对4 - 6名家长进行开发和测试后，我们将进行一项试点研究，其中64名JA儿童的父母将被随机分配到坚持强计划或等待名单控制中。将在基线、治疗后立即和3个月随访时获得依从性（电子监测和家长评分）和生活质量的测量。假设是，与父母被分配到等候名单对照组的孩子相比，父母接受“强依从性”项目的孩子会表现出更高的依从性和生活质量。如果这项初步研究成功，将提出一项更大的多站点R01 RCT来进一步验证依从性强的计划。