title: Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial.
abstract: OBJECTIVE
  The purpose of this study is to evaluate the efficacy of a behavioral self-regulation intervention vs. active control condition using a parallel-group randomized clinical trial with a sample of center hemodialysis patients with chronic kidney disease.
  
  
  METHODS
  Participants were recruited from 8 hemodialysis treatment centers in the Midwest. Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5 kg over a 4-week period, (b) >18 years of age, (c) English-speaking without severe cognitive impairment, (d) treated with center-based hemodialysis for >3 months, and (e) not living in a care facility in which meals were managed. Medical records were used to identify eligible patients. Patients were randomly assigned to either a behavioral self-regulation intervention or active control condition in which groups of 3-8 patients met for hour-long, weekly sessions for 7 weeks at their usual hemodialysis clinic. Primary analyses were intention-to-treat.
  
  
  RESULTS
  Sixty-one patients were randomized to the intervention while 58 were assigned to the attention-placebo support and discussion control. Covariate-adjusted between-subjects analyses demonstrated no unique intervention effect for the primary outcome, interdialytic weight gain (β = 0.13, p = 0.48). Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014).
  
  
  CONCLUSIONS
  The present study found that participation in a behavioral self-regulation intervention resulted in no unique intervention effect on a key indicator of adherence for those with severe chronic kidney disease. There was, however, modest within-subjects improvement in interdialytic weight gain for the intervention group which meshes with other evidence showing the utility of behavioral interventions in this patient population. ClinicalTrials.gov Identifier: NCT01066949.
authors.affiliation: VA Iowa City Healthcare System, Iowa City, IA, USA.|Department of Psychology, The University of Iowa, Iowa City, IA, USA.
authors.forename: M Bryant
authors.initials: MB
authors.lastname: Howren
authors.affiliation: VA Minneapolis Healthcare System, Minneapolis, MN, USA.
authors.forename: Quinn D
authors.initials: QD
authors.lastname: Kellerman
authors.affiliation: VA Iowa City Healthcare System, Iowa City, IA, USA.|Departments of Radiology and Biostatistics, The University of Iowa, Iowa City, IA, USA.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Hillis
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Jamie
authors.initials: J
authors.lastname: Cvengros
authors.affiliation: Department of Internal Medicine, The University of Iowa, Iowa City, IA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Lawton
authors.affiliation: Departments of Psychology and Internal Medicine, The University of Iowa, 11 Seashore Hall East, Iowa City, IA, 52242, USA. alan-christensen@uiowa.edu.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Christensen
mesh_terms: D000328:Adult; D000368:Aged; D001521:Behavior Therapy / Q000379:methods*; D004326:Drinking / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology*; D006435:Renal Dialysis / Q000523:psychology*; D051436:Renal Insufficiency, Chronic / Q000523:psychology / Q000628:therapy*; D000068356:Self-Control / Q000523:psychology*; D016896:Treatment Outcome
keywords: Chronic illness; Intervention; Patient adherence; Randomized controlled trial; Self-regulation