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

Completed

• Conditions: Diabetic Kidney Disease

• Registration Number: NCT01377688
• Lead Sponsor: Duke University

Brief Summary

We propose to pilot a telehealth approach to evaluate components of risk communication by:

1. 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.

2. Evaluating how this feedback can be incorporated into clinical care by examining 6 month patient outcomes.

Specific Aims are:

1. 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.

2. 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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Study Start: 2011-10
• Status Verified: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Diagnosis of diabetes with progressive kidney disease

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Exclusion Criteria

• Metastatic cancer
• Dementia
• Psychosis
• No Access to phone
• Diagnosis of non-diabetic kidney disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)	6 months

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States