Behavioral Intervention and Adherence in Dialysis

NCT01066949 | Completed Phase 2

• 2 other identifiers: DK72325R01DK072325
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

hemodialysis; behavior change; patient adherence; self management

Outcome Measures

Primary Outcomes (1)

• Interdialysis weight gain

  from enrollment to 6 months post-enrollment

Study Arms (2)

Support and discussion

ACTIVE COMPARATOR

The Support and Discussion protocol will consist of two integrated components: (a) brief educational materials presented at the start of each session, and (b) group leader facilitated discussion following presentation of the educational materials.

Behavioral: Support and discussion

Behavioral Self management

EXPERIMENTAL

Self-Regulation group sessions will be generally highly leader-directed though participants will be regularly encouraged to share their experiences dealing with the dialysis regimen. A consistent attempt will be made to focus all group discussion on self-regulatory principles as they relate to treatment adherence.Session material utilized by group-leaders will be highly structured and detailed across the seven sessions.

Behavioral: Behavioral self mangement

Interventions

Behavioral self mangement BEHAVIORAL

Seven weekly, hour long group sessions focused on enhancing patient behavioral self management skills.

Behavioral Self management

Support and discussion BEHAVIORAL

Seven, weekly hour long group sessions focused on information provision and supportive discussion amongst participants

Support and discussion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Iowa: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Tri-State Dialysis

Dubuque, Iowa, 52001, United States

Location

University of Iowa renal dialysis program

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Howren MB, Cozad AJ, Christensen AJ. The interactive effects of patient control beliefs on adherence to fluid-intake restrictions in hemodialysis: Results from a randomized controlled trial. J Health Psychol. 2017 Nov;22(13):1642-1651. doi: 10.1177/1359105316631813. Epub 2016 Feb 22.

  PMID: 26908586 DERIVED

• Howren MB, Kellerman QD, Hillis SL, Cvengros J, Lawton W, Christensen AJ. Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial. Ann Behav Med. 2016 Apr;50(2):167-76. doi: 10.1007/s12160-015-9741-0.

  PMID: 26631085 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Patient Compliance

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychology

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: June 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (2)