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

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Treatments: Behavioral: Group talks/social chat; Behavioral: Computer assisted education and motivational interviewing.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01067963

1UL1RR025780 (U.S. NIH Grant/Contract)

08-0939

RWJ64198 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Behavioral-education/counseling

Experimental group

Description:

Computer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing

Treatment:

Behavioral: Computer assisted education and motivational interviewing.

Group talks/social chat

Placebo Comparator group

Description:

Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content.

Treatment:

Behavioral: Group talks/social chat