Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes

Study Overview
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Brief Summary
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We propose to pilot a telehealth approach to evaluate components of risk communication by: Providing personalized tailored patient feedback to help initiate and maintain specific diabetic kidney disease (DKD)-related behaviors (e.g., medication adherence, weight, exercise, diet, smoking cessation) to reduce their risks. Evaluating how this feedback can be incorporated into clinical care by examining 6 month patient outcomes. Specific Aims are: To evaluate the feasibility and acceptability of providing both patients and their provider feedback on individuals' DKD risk via the telehealth intervention and incorporating it into regular clinical practice. If improvements in outcomes are found, to estimate the cost of the program in terms of the patient, provider, and overall costs of implementing the program.

Detailed Description
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We propose an innovative telehealth approach that has reduced antecedents of kidney disease, including poor blood pressure and glucose control, but has never been used to treat DKD. To mitigate the growing burden of DKD, these studies are designed to determine whether a potentially scalable, telehealth intervention effectively slows progression of DKD in a diverse US population and whether it is also cost-effective. The intervention simultaneously addresses medication management and behavioral therapies and education that seek to optimize adherence and self-efficacy. This proposed pilot trial will begin to evaluate if a multifactorial telehealth intervention may be effective in reducing progression of DKD.

Official Title
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Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes

Conditions
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Diabetic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of diabetes with progressive kidney disease Exclusion Criteria: Metastatic cancer Dementia Psychosis No Access to phone Diagnosis of non-diabetic kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetics with PKD<br>Diagnoses of diabetes type 2 with progressive kidney disease (slope of eGFR decline between -15 to -3 ml/min/1.73m2 per year, estimated by calculating an eGFR for each creatinine using the 4-variable Modification of Diet in Renal Disease Study [MDRD] equation and conducting a simple ordinary least squares regression from these values to evaluate changes over time to derive each individuals' slope of eGFR, annualized using test dates) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DKD