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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01377688
Other study ID # Pro00030501
Secondary ID
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


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
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