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

Self-management of Type 2 Diabetes and Chronic Kidney Disease

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01067963
Acronym
SMaRT
Enrollment
80
Registered
2010-02-12
Start date
2009-12-31
Completion date
2012-10-31
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

Keywords

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

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.

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.

Interventions

BEHAVIORALComputer assisted education and motivational interviewing.

9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.

BEHAVIORALGroup 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.

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
National Center for Research Resources (NCRR)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026