Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease

NCT01067963 | Terminated

• 3 other identifiers: 08-09391UL1RR025780RWJ64198
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to establish the usefulness and the impact of a tailored behavioral-education and counseling intervention titled Self-Management and Resourceful Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic kidney disease, in order to help them to manage their behaviors related to their condition and health.

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Keywords

self-care; self-management; health behavior change; motivational interviewing; computer assisted learning

Outcome Measures

Primary Outcomes (1)

• Primary outcomes utilized in this study will be disease burden (measured as diabetes-related distress), quality of life (measured as health related QOL), and glycemic health (measured as hemoglobin A1C).

  One year

Secondary Outcomes (1)

• Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.

  One year

Study Arms (2)

Behavioral-education/counseling

EXPERIMENTAL

Computer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing

Behavioral: Computer assisted education and motivational interviewing.

Group talks/social chat

PLACEBO COMPARATOR

Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.

Behavioral: Group talks/social chat

Interventions

Computer assisted education and motivational interviewing. BEHAVIORAL

9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.

Also known as: Experimental Group

Behavioral-education/counseling

Group talks/social chat BEHAVIORAL

9 study contact points. 3 group talk session on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.

Also known as: Attention Control Group

Group talks/social chat

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Type 2 Diabetes
• years old
• Stage 3 Chronic Kidney Disease
• Speaks and reads English

You may not qualify if:

• Hypoglycemia with 3rd party treatment in past 3 months
• Type 1 Diabetes
• On Dialysis
• Does not speak English
• Factors likely to preclude protocol adherence

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Robert Wood Johnson Foundation: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

VA Eastern Colorado Hospital

Denver, Colorado, 80220, United States

Location

Related Publications (39)

• Coresh J, Astor BC, Greene T, Eknoyan G, Levey AS. Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis. 2003 Jan;41(1):1-12. doi: 10.1053/ajkd.2003.50007.

  PMID: 12500213 BACKGROUND

• Franz MJ, Bantle JP, Beebe CA, Brunzell JD, Chiasson JL, Garg A, Holzmeister LA, Hoogwerf B, Mayer-Davis E, Mooradian AD, Purnell JQ, Wheeler M; American Diabetes Association. Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. Diabetes Care. 2003 Jan;26 Suppl 1:S51-61. doi: 10.2337/diacare.26.2007.s51. No abstract available.

  PMID: 12502619 BACKGROUND

• Berridge E, Roudsari A, Taylor S, Carey S. Computer-aided learning for the education of patients and family practice professionals in the personal care of diabetes. Comput Methods Programs Biomed. 2000 Jul;62(3):191-204. doi: 10.1016/s0169-2607(00)00067-5.

  PMID: 10837906 BACKGROUND

• National Kidney Foundation [NKF]. Kidney disease outcomes quality initiative (K/DOQI): Clinical Practice Guideline 2-evaluation and treatment 2002: Accessed March 21, 2008 from http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g2.htm.

  BACKGROUND

• Khosla N, Bakris G. Lessons learned from recent hypertension trials about kidney disease. Clin J Am Soc Nephrol. 2006 Mar;1(2):229-35. doi: 10.2215/CJN.00840805. Epub 2005 Nov 30. No abstract available.

  PMID: 17699211 BACKGROUND

• Kshirsagar AV, Joy MS, Hogan SL, Falk RJ, Colindres RE. Effect of ACE inhibitors in diabetic and nondiabetic chronic renal disease: a systematic overview of randomized placebo-controlled trials. Am J Kidney Dis. 2000 Apr;35(4):695-707. doi: 10.1016/s0272-6386(00)70018-7.

  PMID: 10739792 BACKGROUND

• National Kidney Foundation [NKF]. Kidney Disease Outcomes Quality Initiative (K/DOQI): Clinical Practice Guideline 9-assoc of level of GFR with nutritional status and Guideline 24-dietary protein intake for nondialyzed patients, 2002.

  BACKGROUND

• Perlman RL, Kiser M, Finkelstein F, Eisele G, Roys E, Liu L, Burrows-Hudson S, Port F, Messana JM, Bailie G, Rajagopalan S, Saran R. The longitudinal chronic kidney disease study: a prospective cohort study of predialysis renal failure. Semin Dial. 2003 Nov-Dec;16(6):418-23. doi: 10.1046/j.1525-139x.2003.16093.x.

  PMID: 14629599 BACKGROUND

• KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.

  PMID: 17276798 BACKGROUND

• Glasgow RE, Hiss RG, Anderson RM, Friedman NM, Hayward RA, Marrero DG, Taylor CB, Vinicor F. Report of the health care delivery work group: behavioral research related to the establishment of a chronic disease model for diabetes care. Diabetes Care. 2001 Jan;24(1):124-30. doi: 10.2337/diacare.24.1.124.

  PMID: 11194217 BACKGROUND

• Rollnick S, Mason P, Butler C. Health behavior change: A guide for practitioners. Edinburgh, Scotland: Churchill Livingstone Elsevier; 1999.

  BACKGROUND

• Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. Prog Behav Modif. 1992;28:183-218. No abstract available.

  PMID: 1620663 BACKGROUND

• Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: Helping patients change behavior. New York: Guilford Press; 2007.

  BACKGROUND

• Glasgow RE, Boles SM, McKay HG, Feil EG, Barrera M Jr. The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results. Prev Med. 2003 Apr;36(4):410-9. doi: 10.1016/s0091-7435(02)00056-7.

  PMID: 12649049 BACKGROUND

• Gerber BS, Brodsky IG, Lawless KA, Smolin LI, Arozullah AM, Smith EV, Berbaum ML, Heckerling PS, Eiser AR. Implementation and evaluation of a low-literacy diabetes education computer multimedia application. Diabetes Care. 2005 Jul;28(7):1574-80. doi: 10.2337/diacare.28.7.1574.

  PMID: 15983303 BACKGROUND

• Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.

  PMID: 17716083 BACKGROUND

• Brown SA. Studies of educational interventions and outcomes in diabetic adults: a meta-analysis revisited. Patient Educ Couns. 1990 Dec;16(3):189-215. doi: 10.1016/0738-3991(90)90070-2.

  PMID: 2149753 BACKGROUND

• Himmelfarb J. Chronic kidney disease and the public health: gaps in evidence from interventional trials. JAMA. 2007 Jun 20;297(23):2630-3. doi: 10.1001/jama.297.23.2630. No abstract available.

  PMID: 17579231 BACKGROUND

• American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.

  PMID: 18165335 BACKGROUND

• Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.

  PMID: 15367063 BACKGROUND

• Sakraida TJ, Robinson MV. Health literacy self-management by patients with type 2 diabetes and stage 3 chronic kidney disease. West J Nurs Res. 2009 Aug;31(5):627-47. doi: 10.1177/0193945909334096. Epub 2009 Apr 23.

  PMID: 19390053 BACKGROUND

• Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.

  PMID: 7555499 BACKGROUND

• Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.

  PMID: 15735199 BACKGROUND

• Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.

  PMID: 7841967 BACKGROUND

• Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL. Qual Life Res. 1999;8(1-2):79-91. doi: 10.1023/a:1026485130100.

  PMID: 10457741 BACKGROUND

• Ware J, Snow K, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Centre;1993.

  BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Woodcock AJ, Julious SA, Kinmonth AL, Campbell MJ; Diabetes Care From Diagnosis Group. Problems with the performance of the SF-36 among people with type 2 diabetes in general practice. Qual Life Res. 2001;10(8):661-70. doi: 10.1023/a:1013837709224.

  PMID: 11871587 BACKGROUND

• Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.

  PMID: 11769298 BACKGROUND

• Kavookjian J, Berger B, Anderson-Harper H, Barker K, Grimley D, Pearson R, et al. The relationship between readiness for diabetes self-care and glycemic control: The development of a diagnostic tool for pharmacist intervention. Journal of American Pharmaceutical Association 41:320, 2001.

  BACKGROUND

• Greene GW, Rossi SR, Rossi JS, Velicer WF, Fava JL, Prochaska JO. Dietary applications of the stages of change model. J Am Diet Assoc. 1999 Jun;99(6):673-8. doi: 10.1016/S0002-8223(99)00164-9. No abstract available.

  PMID: 10361528 BACKGROUND

• Hellsten LA, Nigg C, Norman G, Burbank P, Braun L, Breger R, Coday M, Elliot D, Garber C, Greaney M, Lees F, Matthews C, Moe E, Resnick B, Riebe D, Rossi J, Toobert D, Wang T. Accumulation of behavioral validation evidence for physical activity stage of change. Health Psychol. 2008 Jan;27(1S):S43-53. doi: 10.1037/0278-6133.27.1(Suppl.).S43.

  PMID: 18248105 BACKGROUND

• Greene GW, Rossi SR, Reed GR, Willey C, Prochaska JO. Stages of change for reducing dietary fat to 30% of energy or less. J Am Diet Assoc. 1994 Oct;94(10):1105-10; quiz 1111-2. doi: 10.1016/0002-8223(94)91127-4.

  PMID: 7930314 BACKGROUND

• Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.

  PMID: 10895844 BACKGROUND

• Stanford Patient Education Research Center, Self Efficacy for Diabetes. Stanford (Accessed March 28, 2008, at http://patienteducation.stanford.edu/research/sediabetes.html.)

  BACKGROUND

• National Kidney Foundation [NKF]. Kidney disease outcomes quality initiative (K/DOQI): Clinical practice Guideline 4-Estimation of GFR Part 5 evaluation of laboratory measures for clinical assessment of kidney disease. 2002: Accessed March 27, 2008 from http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p5_lab_g4.htm.

  BACKGROUND

• Lynn MR. Determination and quantification of content validity. Nurs Res. 1986 Nov-Dec;35(6):382-5. No abstract available.

  PMID: 3640358 BACKGROUND

• Sheiner LB, Rubin DB. Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995 Jan;57(1):6-15. doi: 10.1016/0009-9236(95)90260-0. No abstract available.

  PMID: 7828382 BACKGROUND

• Aubert RE, Herman WH, Waters J, Moore W, Sutton D, Peterson BL, Bailey CM, Koplan JP. Nurse case management to improve glycemic control in diabetic patients in a health maintenance organization. A randomized, controlled trial. Ann Intern Med. 1998 Oct 15;129(8):605-12. doi: 10.7326/0003-4819-129-8-199810150-00004.

  PMID: 9786807 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; 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

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Teresa J. Sakraida, PhD, RN

  University of Colorado Denver College of Nursing

  PRINCIPAL INVESTIGATOR

• Alkesh Jani, MD

  University of Colorado Denver, School of Medicine and VA Eastern Colorado Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 12, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 9, 2015

Record last verified: 2013-01

Locations

US (2)