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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377688
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
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.

Condition or disease
Diabetic Kidney Disease

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.

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
Study Start Date : October 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetics with progressive kidney disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01377688

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Hayden B Bosworth, PhD Duke Universtiy Medical Center

Responsible Party: Duke University Identifier: NCT01377688     History of Changes
Other Study ID Numbers: Pro00030501
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: March 2014

Keywords provided by Duke University:

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases