Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes (DKDPilot)
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.
Diabetic Kidney Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes|
- Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377688
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Hayden B Bosworth, PhD||Duke Universtiy Medical Center|