View Clinical Trial (Medical Research Study)
Behavioral Intervention and Adherence in Dialysis
| City: |
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Dubuque |
| State: |
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Iowa |
| Zip Code: |
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52001 |
| Conditions: |
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Hemodialysis - Behavior Change - Patient Adherence |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients will be deemed eligible if they have a mean (averaged over the preceeding
four weeks) pre-enrollment, interdialysis weight gain (IWG) greater than 2.5 kg.
Other inclusion criteria will include having been receiving hemodialysis for a
minimum of three months, patient age over 18 years, and English speaking.
Exclusion Criteria:
- Patients residing in a nursing home/long-term care facility will be excluded from
participation primarily due to likelihood of diminished patient self-management of
diet and fluid intake in this setting.
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| NCT ID: |
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NCT01066949 |
| Primary Contact: |
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Alan Christensen, PhD
Phone: 319-335-2405
Email: alan-christensen@uiowa.edu
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| Backup Contact: |
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Email: quinn-kellerman@uiowa.edu
Quinn Kellerman, MA
Phone: 319-335-3768
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| Location Contact: |
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Dubuque, Iowa 52001
United States
Diane Boleyn
Phone: 563-589-4033
Email: Dianne.Boleyn@DubuqueInternalMed.com]
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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