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

Diabetes Mellitus, Type 2 Clinical Trial

— SMaRT  

Official title:

Self-management of Type 2 Diabetes and Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01067963
• Other study ID #: 08-0939
• Secondary ID: 1UL1RR025780RWJ6
• Status: Terminated
• Phase: N/A
• First received: February 10, 2010
• Last updated: June 5, 2015
• Start date: December 2009
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	VA Eastern Colorado Hospital	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Research Resources (NCRR), Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.		One year	No