iCanCope With NF: Innovating an Efficacious Digital Self-management and Transitional Care Program for Adolescents With Neurofibromatosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Feasibility of iCanCope NF
研究概览
简要总结
Neurofibromatosis Type 1 (NF1) often significantly impairs the mental health, social life, self-esteem, and quality of life of adolescent patients. These impacts can be made worse with the experience of NF1-related pain. Nearly three-quarters (73%) of caregivers report that pain interferes with their child's daily functioning, including their mental health, activity, sleep, relationships, and school attendance. Our team has developed the first mobile self-management platform app for adults with NF1-related pain, called iCanCope with NF. It is designed to help people to track their pain, sleep, mood, exercise, and energy level. It helps them set goals, gives suggestions about how to deal with NF1-related pain, and connects them with other individuals living with NF. The goal of this project is to test out a modified version of iCanCope with NF, for youth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinded data analysis will be conducted by an independent biostatistician
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with NF1
- •Experience of NF1-related pain or discomfort that interfered with function over the past 2 weeks
- •Able to speak and read English
排除标准
- •Moderate to severe cognitive impairments that would prevent independent use the iCanCope intervention, as determined through consultation with their health care provider
研究组 & 干预措施
iCanCope-NF Youth
This group will receive access to the intervention on their personal smart phone, or a loaned study phone and charger, for a period of 2 months.
干预措施: iCanCope-NF Youth app (Other)
iCanCope-NF Youth with Contingency Management (CM)
This group (iCanCope+CM) will receive access to the intervention on their personal smart phone, or a loaned study phone, for a period of 2 months. In addition to the standardized orientation and push notifications, this group will also be able to earn incentives aligned with their program engagement.
干预措施: iCanCope-NF Youth app + CM (Other)
Wait-list control
This group will continue to receive their usual care for 2 months. After completion of their follow-up outcome measures, they will be offered access to the iCanCope-NF Youth program. Participants will be reminded they should us their usual emergency care channels during the study if needed. iCanCope does not replace usual care. If participants need physical or mental health support during the study, they will be directed to resources within their community, primary care provider, specialist, or urgent care/emergency care.
结局指标
主要结局
Feasibility of iCanCope NF
时间窗: 8 weeks
Success will be defined as meeting the following four combined criteria: 1) accrual rate \>70% 2) attrition rate \<20%; 3) technical difficulties in fewer than 10% of cases; and acceptability of mean 4 or higher on the acceptability e-scale.
次要结局
- Pain Interference(8 weeks)
- Pain Severity(8 weeks)
- Pain management(8 weeks)
- Transition readiness(8 weeks)
- Depressive symptoms(8 weeks)
- Anxiety(8 weeks)
- Health-related quality of life(8 weeks)
研究者
Jennifer Stinson
Clinician Scientist
The Hospital for Sick Children