We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01067963
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : June 9, 2015
Robert Wood Johnson Foundation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Self-management of Type 2 Diabetes and Chronic Kidney Disease
Study Start Date : December 2009
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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). [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067963

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)
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

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.
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.
Rollnick S, Mason P, Butler C. Health behavior change: A guide for practitioners. Edinburgh, Scotland: Churchill Livingstone Elsevier; 1999.
Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. In: Hersen M, Eisler R, eds. Progress in behavior modification. Newbury Park, CA: Sage Publications; 1992.
Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: Helping patients change behavior. New York: Guilford Press; 2007.
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.
Standards of Medical Care in Diabetes 2008. Diabetes Care 31:S12-S54, 2008.
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.
Stanford Patient Education Research Center, Self Efficacy for Diabetes. Stanford (Accessed March 28, 2008, at http://patienteducation.stanford.edu/research/sediabetes.html.)
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.
Lynn ML. Determination and quantification of content validity. Nursing Research 35:362-5, 1996.

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01067963     History of Changes
Other Study ID Numbers: 08-0939
1UL1RR025780 ( U.S. NIH Grant/Contract )
RWJ64198 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: January 2013

Keywords provided by University of Colorado, Denver:
health behavior change
motivational interviewing
computer assisted learning

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Diabetes Mellitus, Type 2
Renal Insufficiency
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases