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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01067963
First received: February 10, 2010
Last updated: January 29, 2013
Last verified: January 2013
  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:


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
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, see Learn About Clinical Studies.

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
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:
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.
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.
Hettema J, Steele J, Miller WR. Motivational interviewing. Annual Review of Clinical Psychology 1:91-111, 2005.
American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care 31:S12-S54, 2008.
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.
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.
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, 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 October 01, 2014