- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377688
Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes (DKDPilot)
June 2, 2014 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diabetics with progressive kidney disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hayden B Bosworth, PhD, Duke Universtiy Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 20, 2011
First Posted (Estimate)
June 21, 2011
Study Record Updates
Last Update Posted (Estimate)
June 3, 2014
Last Update Submitted That Met QC Criteria
June 2, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00030501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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