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

NCT01377688 | Completed

• 1 other identifier: Pro00030501
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 2.Evaluating how this feedback can be incorporated into clinical care by examining 6 month patient outcomes.
3. 3.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.
4. 4.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.

Conditions

Diabetic Kidney Disease

Keywords

DKD

Outcome Measures

Primary Outcomes (1)

• Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)

  6 months

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetics with progressive kidney disease

You may qualify if:

• Diagnosis of diabetes with progressive kidney disease

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Hayden B Bosworth, PhD

  Duke Universtiy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 21, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 3, 2014

Record last verified: 2014-03

Locations

US (1)