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NCT01066949 · ClinicalTrials.gov registry record · Phase 2
Behavioral Intervention and Adherence in Dialysis
A Phase 2 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
NCT01066949: Completed Phase 2 study, sponsored by University of Iowa.
NCT01066949 is a Phase 2 study that has completed, run by University of Iowa. The registered enrollment target is 119 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01066949, a Phase 2 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
Study Summary
The aim of the proposed work is to conduct a randomized controlled trial (RCT) evaluation of a behavior change intervention designed to enhance fluid-intake adherence (compliance) among hemodialysis patients. Patient non-adherence (non-compliance) with fluid-intake restrictions is a highly pervasive problem in the hemodialysis population with substantial consequences in terms of increased patient morbidity and mortality. Given the prevalence and clinical importance of adherence among ESRD patients, the design and evaluation of interventions to improve patient adherence is critically important. Surprisingly, however, little such empirical work has been conducted in this area. The proposed RCT involves testing the efficacy of a behaviorally based, group-administered, "behavioral self regulation" intervention designed to increase adherence to fluid intake restrictions among hemodialysis patients. This structured intervention is designed to be delivered by healthcare providers in a clinical setting to groups of 4-10 patients over seven, one-hour weekly sessions. This study will compare the effect of the structured intervention group with the effect of an educational and support group on fluid-intake adherence in a sample of approximately 200 fluid non-adherent center hemodialysis patients over a 26-week follow-up period. Both clinical (interdialysis session weight gain) and self-report indices of fluid-intake adherence will be examined. We believe that the proposed research is of potentially very high impact given the high prevalence and clear clinical consequences of hemodialysis patient nonadherence and the potential for a relatively low-cost, structured intervention to significantly reduce this type of maladaptive patient behavior in the hemodialysis treatment context.
Interventions
- BEHAVIORAL Behavioral self mangement
- BEHAVIORAL Support and discussion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01066949 record still lists
NCT01066949 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Behavioral self mangement is the first listed.
NCT01066949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01066949 about?
NCT01066949 is a clinical study titled "Behavioral Intervention and Adherence in Dialysis". The aim of the proposed work is to conduct a randomized controlled trial (RCT) evaluation of a behavior change intervention designed to enhance fluid-intake adherence (compliance) among hemodialysis patients. Patient non-adherence (non-compliance) with fluid-intake restrictions is a highly pervasive...
What is the current status of trial NCT01066949?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2006-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01066949?
The interventions under investigation include: Behavioral self mangement (BEHAVIORAL), Support and discussion (BEHAVIORAL).
Who is sponsoring clinical trial NCT01066949?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01066949's enrollment target sits among peer trials
119 618th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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