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NCT04561765 · ClinicalTrials.gov registry record · NA
Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 122
- Enrollment target
NCT04561765: Completed NA study, sponsored by Yale University.
NCT04561765 is a NA study that has completed, run by Yale University. The registered enrollment target is 122 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04561765, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
Interventions
- DEVICE iCanCope
- DEVICE iCanCope+Contingency Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2022-09-06 |
| Phase | NA |
What the finished NCT04561765 record still lists
NCT04561765 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which iCanCope is the first listed.
NCT04561765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04561765 about?
NCT04561765 is a clinical study titled "Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial". 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 iCan...
What is the current status of trial NCT04561765?
This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2021-03-01. Estimated completion is 2022-09-06.
What interventions are being tested in trial NCT04561765?
The interventions under investigation include: iCanCope (DEVICE), iCanCope+Contingency Management (DEVICE).
Who is sponsoring clinical trial NCT04561765?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04561765's enrollment target sits among peer trials
122 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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