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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Self-management of Type 2 Diabetes and Chronic Kidney Disease

Conditions
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Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral-education/counseling<br>Computer assisted education and telephone counseling using motivational interviewing. Computer assisted education and motivational interviewing | Behavioral: Computer assisted education and motivational interviewing.<br>* 9 study contact points. 3-week intervention using computer-assisted learning modules and telephone counseling using motivational interviewing.<br>* Other names: Experimental Group;|
| Placebo Comparator: Group talks/social chat<br>Group session talks on general topics about healthy lifestyle, printed power point handouts, telephone calls comprised of social conversation to discuss the handout content. | Behavioral: Group talks/social chat<br>* 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.<br>* Other names: Attention Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-care, self-management, health behavior change, motivational interviewing, computer assisted learning