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Diabetic Kidney DiseaseSTOP-DKD APPNCT02418091

Integrated Population Program for Diabetic Kidney Disease

A study testing Telehealth in people with Diabetic Kidney Disease and Uncontrolled Hypertension, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will build a population management system Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP and conduct a 6-month controlled trial to compare reduction of blood pressure. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Telehealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteUnited States
Study dates
Mar 2015to Sep 2016
Phase
Interventional
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

Who may be able to join

None listed.

Who cannot join

  • Patients who meet any one of the exclusion criteria will be excluded:
  • No access to telephone
  • Not proficient in English
  • Nursing home/long-term care facility resident or receiving home health care
  • Impaired hearing/ speech/ vision
  • Participating in another trial (pharmaceutical or behavioral)
Show all 12Show fewer
  • Planning to leave the area in the next 3 years
  • Pancreatic insufficiency or diabetes secondary to pancreatitis
  • Alcohol abuse (>14 alcoholic beverages/ wk)
  • Diagnosis of non-diabetic kidney disease
  • Active malignancy (other than non-melanomatous skin cancer)
  • Diagnosis of life-threatening disease with death probable within 4 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Clinical Research Institute

    Durham, North Carolina, 27715

Other trials in United States

About this study

Official title: STOP-DKD Automated Population Program (APP)

This study will build a population management system Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease STOP-DKD Application STOP-DKD APP and conduct a 6-month controlled trial to compare reduction of blood pressure. In addition, the study will evaluate the feasibility of future large-scale intervention to slow diabetic kidney disease (DKD) DKD progression.

Aim 1: Identify patients with moderate DKD and uncontrolled hypertension (HTN) using existing electronic health record data in an integrated data warehouse (Southeastern Diabetes Initiative- SEDI) to screen all patients within SEDI.

Read more

Aim 2: Implement an intervention designed to slow progression of DKD and treat associated conditions in a high-risk population with moderate DKD and uncontrolled HTN using the STOP-DKD APP

  • Primary Outcome: Test the hypothesis that patients who receive the intervention will have greater improvements in blood pressure as compared to a control group after 6 months
  • Secondary Outcomes: Exploratory analyses to determine whether patients who receive the intervention will have less progression (defined as a smaller decrease in kidney function), and improved behaviors that affect HTN control and cardiovascular risk (medication adherence, diet, physical activity, and weight control) as compared to a control group after 6 months

Aim 3: Evaluate the STOP-DKD APP Study to guide large-scale implementation \& dissemination

  • Impact Evaluation: Assess the potential population impact of our intervention using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework
  • Economic Evaluation: Conduct an economic evaluation using the Archimedes Model by estimating projected costs and quality-adjusted life-years
Being tested
Telehealth
Keywords
patients with moderate DKD and uncontrolled HTN
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelehealthBehavioural

    Using Telehealth to slow progression of diabetic kidney disease automated population program identifies patients and engages them to optimize DKD medication adherence and health behaviors using 2-way communication via patient-selected technology (mobile/web-based applications, text messaging, interactive voice response, or e-mail) backed by case management via the phone for suboptimal control or health status. The STOP-DKDAutomated Population Program will deliver a tailored, multi-factorial intervention to address medication self-management and modify multiple risk factors simultaneously through a combination of patient self-monitoring, behavioral therapies and education that optimize adherence and self-efficacy.

Study groups in NCT02418091
Study groupRoleWhat they receive
Intervention TelehealthExperimentalUsing Telehealth to slow progression of diabetic kidney disease automated population program identifies patients and engages them to optimize DKD medication adherence and health behaviors using 2-way communication via patient-selected technology (mobile/web-based applications, text messaging, interactive voice response, or e-mail) backed by case management via the phone for suboptimal control or health status. The STOP-DKDAutomated Population Program will deliver a tailored, multi-factorial intervention to address medication self-management and modify multiple risk factors simultaneously through a combination of patient self-monitoring, behavioral therapies and education that optimize adherence and self-efficacy.
Receives: Behavioral: Telehealth
Control/No InterventionNo interventionGroup of subjects that will serve as a comparison group. These subjects will not be approached/enrolled for this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Blood Pressure

    Measured: Baseline & 6months

Secondary outcomes (5)

  1. Change in estimated Glomerular filtration rate (eGFR) for kidney function

    Measured: Baseline & 6months

  2. Change in dietary habits as measured by questionnaire

    Measured: Baseline & 6month

  3. Change in weight

    Measured: Baseline & 6month

  4. Change in amount of physical activity as measured by questionnaire

    Investigators will assess whether patients who receive the intervention will have improved behaviors that affect HTN control and cardiovascular risk ( physical activity) as compared to a control group after 6 months

    Measured: Baseline & 6month

  5. Change in taking medicine as prescribed

    Investigators will assess whether patients who receive the intervention will have improved behaviors that affect HTN control and cardiovascular risk (medication adherence) as compared to a control group after 6 months

    Measured: Baseline& 6month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02418091
Sponsor's protocol ID
Pro00052081
Other IDs
1R34DK102166-01
Acronym
STOP-DKD APP
Status last verified
Nov 2016
First submitted
20 Mar 2015
Last updated
21 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Lewinski AA, Patel UD, Diamantidis CJ, Oakes M, Baloch K, Crowley MJ, Wilson J, Pendergast J, Biola H, Boulware LE, Bosworth HB. Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention. J Med Internet Res. 2019 Apr 9;21(4):e12541. doi: 10.2196/12541.

    PubMed 30964439

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth in people with Diabetic Kidney Disease and Uncontrolled Hypertension, 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 0 inclusion and 12 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 21 Nov 2016. 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?

Change in Blood Pressure (time frame: Baseline & 6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02418091, which also lists 1 linked publication.

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 21 Nov 2016.

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