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NCT02511769 · ClinicalTrials.gov registry record · NA
Web-MAP Intervention for Youth With Sickle Cell Disease
A NA study, sponsored by Connecticut Children's Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT02511769: Completed NA study, sponsored by Connecticut Children's Medical Center.
NCT02511769 is a NA study that has completed, run by Connecticut Children's Medical Center. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02511769, a NA study, has completed, sponsored by Connecticut Children's Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment from sickle cell centers will also be determined. The short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral intervention in a large population of youth with SCD. The long-term goal of this research is to develop effective, easily accessible, behavioral pain interventions for youth with SCD to reduce the long-term impact of pain on function, quality of life, and health service use in this population. The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1) Subjects will be randomized to either the behavioral intervention or the online patient education control group. The treatment protocol will be implemented over 8 weeks in Internet-based treatment modules. The primary study outcome is pain and functional impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.
Primary Outcome
We will compare pain intensity (pain scores), pain burden (Sickle Cell Pain Burden Interview), activity limitations (Child Activity Limitations Interview), quality of life (PedsQL), and health service use, and their corresponding changes from baseline to T2 (immediately after finishing the treatment arm) and T3 (6 months after enrollment in study). We will used a paired sample t-test.
Interventions
- BEHAVIORAL WEB-MAP Educational Control Group
- BEHAVIORAL WEB-MAP CBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-08-18 |
| Phase | NA |
What the finished NCT02511769 record still lists
NCT02511769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which WEB-MAP Educational Control Group is the first listed.
NCT02511769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02511769 about?
NCT02511769 is a clinical study titled "Web-MAP Intervention for Youth With Sickle Cell Disease". The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment f...
What is the current status of trial NCT02511769?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2013-09. Estimated completion is 2016-08-18.
What interventions are being tested in trial NCT02511769?
The interventions under investigation include: WEB-MAP Educational Control Group (BEHAVIORAL), WEB-MAP CBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT02511769?
This trial is sponsored by Connecticut Children's Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02511769's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 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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