Behavioral Intervention and Adherence in Dialysis

Completed · Phase 2

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01066949

Run by

University of Iowa

People needed

119

Starts

2006-06-01

Expected to finish

2011-06-01

Last updated by the study team

2015-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tri-State Dialysis — Dubuque, Iowa, United States
• University of Iowa renal dialysis program — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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