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

Diabetic Kidney Disease Clinical Trial

— DKDPilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377688
• Other study ID #: Pro00030501
• Status: Completed
• Phase: N/A
• First received: June 20, 2011
• Last updated: June 2, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: March 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)		6 months	No