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

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ClinicalTrials.gov Identifier: NCT01377688
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
Duke University

June 20, 2011
June 21, 2011
June 3, 2014
October 2011
April 2014   (Final data collection date for primary outcome measure)
Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 6 months ]
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Complete list of historical versions of study NCT01377688 on ClinicalTrials.gov Archive Site
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Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes

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.
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.
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample
Diabetics with progressive kidney disease
Diabetic Kidney Disease
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Diabetics with PKD
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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Duke University
Duke University
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Principal Investigator: Hayden B Bosworth, PhD Duke Universtiy Medical Center
Duke University
March 2014