Diabetic Kidney DiseaseDKDPilotNCT01377688
Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
An observational study of Diabetic Kidney Disease, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetics with progressive kidney disease
Who may be able to join
- Diagnosis of diabetes with progressive kidney disease
Who cannot join
- Metastatic cancer
- Dementia
- Psychosis
- No Access to phone
- Diagnosis of non-diabetic kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Diabetic Kidney Disease
- Keywords
- DKD
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hayden B Bosworth, PhD, Principal investigator, Duke Universtiy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377688
- Sponsor's protocol ID
- Pro00030501
- Acronym
- DKDPilot
- Status last verified
- Mar 2014
- First submitted
- 20 Jun 2011
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes
- ClinicalTrials.gov ID
- NCT01377688
- Acronym / sponsor ID
- DKDPilot / Pro00030501
- Conditions
- Diabetic Kidney Disease
- Keywords
- DKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetics with progressive kidney disease
Key inclusion criteria (1 listed)
- Diagnosis of diabetes with progressive kidney disease
Key exclusion criteria (5 listed)
- Metastatic cancer
- Dementia
- Psychosis
- No Access to phone
- Diagnosis of non-diabetic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayden B Bosworth, PhD principal investigator
Duke Universtiy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure and /or Estimated Glomerular Filtration Rate (eGFR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.