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.
Method
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
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References
Christensen AJ. Patient adherence to medical treatment regimens: Bridging the gap between behavioral science and biomedicine. New Haven: Yale University Press; 2004.
Howren MB, Van Liew JR, Christensen AJ. Advances in patient adherence to medical treatment regimens: The emerging role of technology in adherence monitoring and management. Soc Pers Psychol Compass—Health Ser. 2013; 7: 427-443.
Denhaerynck K, Manhaeve D, Dobbels F, et al. Prevalence and consequences of nonadherence to hemodialysis regimens. Am J Crit Care. 2007; 16: 222-235.
Bame SI, Petersen N, Wray NP. Variation in hemodialysis patient compliance according to demographic characteristics. Soc Sci Med. 1993; 37: 1035-1043.
Christensen AJ, Moran PJ, Lawton WJ, et al. Monitoring attentional style and medical regimen adherence in hemodialysis patients. Health Psychol. 1997; 16: 256-262.
Friend R, Hatchett L, Schneider MS, et al. A comparison of attributions, health beliefs, and negative emotions as predictors of fluid adherence in renal dialysis patients: A prospective analysis. Ann Behav Med. 1997; 19: 344-347.
Schneider MS, Friend R, Whitaker P, et al. Fluid noncompliance and symptomatology in end-stage renal disease: Cognitive and emotional variables. Health Psychol. 1991; 10: 209-215.
Christensen AJ, Ehlers SL. Psychological factors in end-stage renal disease: An emerging context for behavioral medicine research. J Consult Clin Psychol. 2002; 70: 712-724.
Barnes MR. Token economy control of fluid overload in a patient receiving hemodialysis. J Behav Ther Exp Psychiatry. 1976; 7: 305-306.
Carton JS, Schweitzer JB. Use of a token economy to increase compliance during hemodialysis. J Appl Behav Anal. 1996; 29: 111-113.
Hart R. Utilization of token economy within a chronic dialysis unit. J Consult Clin Psychol. 1979; 47: 646-648.
Hegel MT, Ayllon T, Thiel G, et al. Improving adherence to fluid-restrictions in male hemodialysis patients: A comparison of cognitive and behavioral approaches. Health Psychol. 1992; 11: 324-330.
Keane TM, Prue DM, Collins FL. Behavioral contracting to improve dietary compliance in chronic renal dialysis patients. J Behav Ther Exp Psychiatry. 1981; 12: 63-67.
Mosley TH, Eisen AR, Bruce BK, Brantley PJ, Cocke TB. Contingent social reinforcement for fluid compliance in a hemodialysis patient. J Behav Ther Exp Psychiatry. 1993; 1: 77-81.
Sharp J, Wild MR, Gumley AI, et al. A cognitive behavioral group approach to enhance adherence to hemodialysis fluid restrictions: A randomized controlled trial. Am J Kidney Dis. 2005; 45: 1046-1057.
Tsay SL. Self-efficacy training for patients with end-stage renal disease. J Adv Nurs. 2003; 43: 370-375.
Bonner A, Havas K, Douglas C, et al. Self-management programmes in stages 1–4 chronic kidney disease: A literature review. J Ren Care. 2014; 40: 194-204.
Clark S, Farrington K, Chilcot J. Nonadherence in dialysis patients: Prevalence, measurement, outcome, and psychological determinants. Sem Dial. 2014; 27: 42-49.
Kaptein AA, van Dijk S, Broadbent E, et al. Behavioural research in patients with end-stage renal disease: A review and research agenda. Patient Educ Couns. 2010; 81: 23-29.
Sharp J, Wild MR, Gumley AI. A systematic review of psychological interventions for the treatment of nonadherence to fluid-intake restrictions in people receiving hemodialysis. Am J Kidney Dis. 2005; 45: 15-27.
Matteson ML, Russell C. Interventions to improve hemodialysis adherence: A systematic review of randomized-controlled trials. Hemodial Int. 2010; 14: 370-382.
Welch JL, Thomas-Hawkins C. Psycho-educational strategies to promote fluid adherence in adult hemodialysis patients: A review of intervention studies. Int J Nurs Stud. 2005; 42: 597-608.
Christensen AJ, Moran PJ, Wiebe JS, et al. Effect of a behavioral self-regulation intervention on patient in hemodialysis. Health Psychol. 2002; 21: 393-397.
Kanfer FH, Gaelick L. Self-management methods. In: Kanfer F, Goldstein A, eds. Helping People Change. 3rd ed. New York: Pergamon Press; 1986: 283-345.
Maes S, Karoly P. Self-regulation assessment and intervention in physical health and illness: A review. Appl Psychol: Int Rev. 2005; 54: 267-299.
Hener T, Weisenberg M, Har-Even D. Supportive versus cognitive-behavioral intervention programs in achieving adjustment to home peritoneal kidney dialysis. J Consult Clin Psychol. 1996; 64: 731-741.
Christensen AJ, Raichle K. End-stage renal disease. In: Christensen AJ, Anotoni MH, eds. Chronic Physical Disorders: Behavioral Medicine’s Perspective. Malden: Blackwell Publishers Ltd; 2002: 220-243.
Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960; 20: 37-46.
Kaplan De-Nour A, Czaczkes JW. Personality factors in chronic hemodialysis patients causing noncompliance with medical regimen. Psychosom Med. 1972; 34: 333-344.
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. New York: Springer; 2010.
Piantadosi S. Clinical trials: A methodologic perspective. Hoboken: Wiley-Interscience; 2005.
Ellenberg JH. Intent-to-treat analysis versus as-treated analysis. Drug Inform J. 1996; 30: 535-544.
Miladinovic B, Kumar A, Hozo I, et al. Instrumental variable meta-analysis of individual patient data: Application to adjust for treatment non-compliance. BMC Med Res Methodol. 2011; 11: 55.
U.S. Renal Data System, USRDS 2014 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, 2014.
Leggat JE, Orzol SM, Hulbert-Shearon TE, et al. Noncompliance in hemodialysis: Predictors and survival analysis. Am J Kidney Dis. 1998; 32: 139-145.
Saran R, Bragg-Gresham JL, Rayner HC, et al. Nonadherence in hemodialysis: Associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney Int. 2003; 64: 254-262.
Szczech LA, Reddan DN, Klassen PS, et al. Interactions between dialysis-related volume exposures, nutritional surrogates and mortality among ESRD patients. Nephrol Dial Transplant. 2003; 18: 1585-1591.
Mohr DC, Spring B, Freedland KE, et al. The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychother Psychosom. 2009; 78: 275-284.
Bloch S, Crouch E, Reibstein J. Therapeutic factors in group psychotherapy. Arch Gen Psychiatry. 1981; 38: 519-526.
Zvolensky MJ, Vujanovic AA, Bernstein A, et al. Distress tolerance: Theory, measurement, and relations to psychopathology. Curr Dir Psychol Sci. 2010; 19: 406-410.
Leyro TM, Zvolensky MJ, Bernstein A. Distress tolerance and psychopathological symptoms and disorders: A review of the empirical literature among adults. Psychol Bull. 2010; 136: 576-600.
Brown RA, Lejuez CW, Strong DR, et al. A prospective examination of distress tolerance and early smoking lapse in adult self-quitters. Nicotine Tob Res. 2009; 11: 493-502.
Lillis J, Hayes SC, Bunting K, et al. Teaching acceptance and mindfulness to improve the lives of the obese: A preliminary test of a theoretical model. Ann Behav Med. 2009; 37: 58-69.
O’Cleirigh C, Ironson G, Smits JAJ. Does distress tolerance moderate the impact of major life events on psychosocial variables and behaviors important in the management of HIV. Behav Ther. 2007; 38: 314-323.
Chilcot J, Wellsted D, Farrington K. Illness representations are associated with fluid nonadherence among hemodialysis patients. J Psychosom Res. 2010; 68: 203-212.
Collins LM, Murphy SA, Nair VN, et al. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med. 2005; 30: 65-73.
Acknowledgements
Preparation of this article was supported in part by NIDDK grant R01DK072325 awarded to Alan J. Christensen. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.
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Howren, M.B., Kellerman, Q.D., Hillis, S.L. et al. Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial. ann. behav. med. 50, 167–176 (2016). https://doi.org/10.1007/s12160-015-9741-0
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DOI: https://doi.org/10.1007/s12160-015-9741-0