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临床试验/NCT04561765
NCT04561765已完成不适用

Innovation in the Treatment of Persistent Pain in Adults With Neurofibromatosis Type 1 (NF1): Implementation of the iCanCope Mobile Application- Clinical Trial

Yale University2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
Engagement Activity

研究概览

简要总结

To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the Mindfulness based alternative approaches (MBAA) to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults 18+
  • able to read and understand English at 5th grade level
  • permanently reside in the United States
  • have pain interference aggregate scores of three or more in the last two weeks using the Brief Pain Inventory-Short Form (BPI-SF) scale

排除标准

  • have an undiagnosed case of NF1
  • have documented major co-occurring psychiatric disease
  • have moderate to severe cognitive deficits
  • have depression assessed using the Patient Health Questionnaire (PHQ-9) or anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7) greater than or equal to the appropriate thresholds (10=mild major depression; 5=mild severe anxiety)

结局指标

主要结局

Engagement Activity

时间窗: through the completion of the study, on average 4 months.

Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.

Pain Severity

时间窗: through the completion of the study, on average 4 months.

A comparison within groups change of pain severity measured by the Brief Pain Inventory-Short Form. Respondents rate items on a 0-10 scale to indicate the pain severity and interference, and the total score is the mean of each subfactor. The higher the score indicates more severity and interference of pain.

Pain Interference Index

时间窗: through the completion of the study, on average 4 months.

A comparison within groups change of pain interference measured by the Pain Interference Index Scale. Respondents rate items on a 0-6 scale to indicate how much pain has interfered with various activities, and the total score is the mean of the six items. Where 6 indicates high interference. Presented here are the non-linear converted T scores with a 'population' mean of 50 and standard deviation of 10. Scores above 50 indicate more pain interference.

次要结局

  • Treatment Services Review(through the completion of the study, on average 4 months.)
  • Sleep Functioning(through the completion of the study, on average 4 months.)
  • Short Form/Quality of Life(through the completion of the study, on average 4 months.)
  • Chronic Pain Acceptance(through the completion of the study, on average 4 months.)
  • Psychological Inflexibility in Pain Scale: Avoidance(through the completion of the study, on average 4 months.)
  • Anxiety(through the completion of the study, on average 4 months.)
  • Psychological Inflexibility in Pain Scale: Cognitive(through the completion of the study, on average 4 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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