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; 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试点研究是针对少年关节炎儿童（JA）的父母的创新教育和基于行为的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，以证明合理的随机临床试验是合理的。拟议的研究涉及国家关节炎和肌肉骨骼和皮肤疾病研究所的行为和生物心理社会研究优先事项（NIAMS），特别是“针对非药理干预措施的研究以及组合的干预措施，包括个人，组，基于技术的干预措施，以增强自我管理和医学范围，以提高健康范围，以提高健康阶级，以提高健康级别的行为。儿童和青少年患有慢性儿科疾病的健康和生活质量[35]。通常要求患有JA的儿童及其父母始终如一地遵守各种治疗方案，最值得注意的是，药物，治疗锻炼和关节的夹板。这些方案中的许多可能会延迟有益作用，并且在短期内可能会导致不良的副作用，例如胃肠道刺激和疼痛。长期遵守的需求，延迟的有益作用和负面影响都是小儿慢性疾病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的依从性”，该计划旨在帮助父母增强子女对JA的医疗方案的遵守，包括药物，治疗性运动和关节的夹板。在使用4至6位父母开发和测试该计划之后，我们将进行一项试点研究，其中有64名JA儿童的父母将被随机分配到依从性计划或候补名单中。依从性（电子监测和母公司评分）的度量和生活质量将在基线，立即治疗后立即进行和3个月的随访。假设是，与父母被分配到侍应生列表对照组的孩子相比，父母接受依从性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，将提出更大的多站点R01 RCT，以进一步验证依从性计划。 公共卫生相关性：这项R21试点研究是针对少年关节炎儿童（JA）的父母的创新教育和基于行为网络的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，以证明合理的随机临床试验是合理的。