Clinical trial NCT01067963: Self-Management and Resourceful Transition of Type 2 Diabetes With Stage 3 Kidney Disease
Official title: Self-management of Type 2 Diabetes and Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Keywords: self-care
self-management
health behavior change
motivational interviewing
computer assisted learning
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: National Center for Research Resources (NCRR)
First posted: 2010-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
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).
timeFrame: One year
Secondary outcomes:
measure: Secondary exploratory outcomes for quality of life include measures of health-related quality of life for diabetes and overall quality of life.
timeFrame: One year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: VA Eastern Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado Denver College of Nursing
name: Teresa J. Sakraida, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver, School of Medicine and VA Eastern Colorado Hospital
name: Alkesh Jani, MD
role: PRINCIPAL_INVESTIGATOR
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