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

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic	Behavioral: Computer assisted education and motivational interviewing. Behavioral: Group talks/social chat

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Self-management of Type 2 Diabetes and Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

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). [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2009
Estimated Study Completion Date:	October 2013
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Behavioral-education/counseling Computer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing	Behavioral: Computer assisted education and motivational interviewing. 9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing. Other Name: Experimental Group
Placebo Comparator: Group talks/social chat 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 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. Other Name: Attention Control Group

Detailed Description:

The SMaRT intervention is a 3-week intervention that uses a combined behavioral-education and counseling methodology. The combined intervention involves computer-aided education alongside telephone counseling via motivational interviewing. The computer-aided education is tailored to the diagnoses of type 2 diabetes and chronic kidney disease and designed in a learning module approach to facilitate goal-setting and discussion of health concerns with greater efficacy and in a more informed way during the brief office visit. Such Computer-aided education has been used to improve diabetes self-management and glycemic control in middle-aged to older adults with moderate success. The inclusion of CKD information will augment current diabetes self-management intervention. The telephone counseling using the evidence-based behavioral change approach of motivational interviewing is a patient-centered approach of partnering with patients by eliciting their health-related concerns. This approach tailors the SMaRT intervention to include collaborative goal-setting with guidance based upon the patient's readiness for change.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed Type 2 Diabetes
18-85 years old
Stage 3 Chronic Kidney Disease
Speaks and reads English

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067963

Locations

United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
VA Eastern Colorado Hospital
Denver, Colorado, United States, 80220

Sponsors and Collaborators

University of Colorado, Denver

Robert Wood Johnson Foundation

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:	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

More Information

Publications:

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.

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. No abstract available.

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.

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

Kshirasagar AV, Joy MS, Hogan SL, Falk RJ, Colindres RE. Effect of ACE inhibitors and nondiabetic chronic renal disease: a systematic review of randomized-placebo-controlled trials. American Journal of Kidney Disease 41:12, 2000.

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.

National Kidney Foundation. KDQOI clinical practice guidelines and clinical practice recommendations for diabetes and chronic kidney disease. American Journal of Kidney Disease 49:S1-S180, 2007.

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. Review.

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.

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.

Hettema J, Steele J, Miller WR. Motivational interviewing. Annual Review of Clinical Psychology 1:91-111, 2005.

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

American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care 31:S12-S54, 2008.

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.

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. Epub 2009 Apr 23.

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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.

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.

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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.

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

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.

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.

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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.

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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.

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01067963 History of Changes
Other Study ID Numbers:	08-0939, 1UL1RR025780, RWJ64198
Study First Received:	February 10, 2010
Last Updated:	January 29, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:

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

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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