Behavioral Intervention and Adherence in Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University of Iowa.
Recruitment status was Recruiting

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by:

University of Iowa

ClinicalTrials.gov Identifier:

NCT01066949

First received: February 9, 2010

Last updated: NA

Last verified: January 2010

History: No changes posted

Purpose

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.

Condition	Intervention	Phase
Hemodialysis Behavior Change Patient Adherence	Behavioral: Behavioral self mangement Behavioral: Support and discussion	Phase 2

Study Type:	Interventional
Study Design:	Primary Purpose: Supportive Care
Official Title:	Behavioral Intervention and Adherence in Dialysis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Interdialysis weight gain [ Time Frame: from enrollment to 6 months post-enrollment ] [ Designated as safety issue: No ]

Study Start Date:	June 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Support and discussion	Behavioral: Support and discussion Seven, weekly hour long group sessions focused on information provision and supportive discussion amongst participants
Experimental: Behavioral Self management	Behavioral: Behavioral self mangement Seven weekly, hour long group sessions focused on enhancing patient behavioral self management skills.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066949

Contacts

Contact: Alan Christensen, PhD	319-335-2405	alan-christensen@uiowa.edu
Contact: Quinn Kellerman, MA	319-335-3768	quinn-kellerman@uiowa.edu

Locations

United States, Iowa
Tri-State Dialysis	Recruiting
Dubuque, Iowa, United States, 52001
Contact: Diane Boleyn 563-589-4033 Dianne.Boleyn@DubuqueInternalMed.com]
University of Iowa renal dialysis program	Active, not recruiting
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

No publications provided

Responsible Party:	Alan J. Christensen, University of Iowa
ClinicalTrials.gov Identifier:	NCT01066949 History of Changes
Other Study ID Numbers:	DK72325, R01DK072325
Study First Received:	February 9, 2010
Last Updated:	February 9, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

hemodialysis
behavior change
patient adherence
self management

ClinicalTrials.gov processed this record on May 16, 2013

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