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.

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: DKDPilot

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jun 21, 2011
Registry last updated: Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed