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

February 10, 2010
January 29, 2013
December 2009
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01067963 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease
Self-management of Type 2 Diabetes and Chronic Kidney Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Renal Insufficiency, Chronic
  • 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
  • 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
  • Experimental: Behavioral-education/counseling

    Computer assisted education and telephone counseling using motivational interviewing.

    Computer assisted education and motivational interviewing

    Intervention: Behavioral: Computer assisted education and motivational interviewing.
  • 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.
    Intervention: Behavioral: Group talks/social chat

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
80
October 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01067963
08-0939, 1UL1RR025780, RWJ64198
No
University of Colorado, Denver
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
University of Colorado, Denver
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP