NCT02418091

Brief 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. 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

March 20, 2015

Last Update Submit

November 18, 2016

Conditions

Diabetic Kidney DiseaseUncontrolled Hypertension

Keywords

patients with moderate DKD and uncontrolled HTN

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Pressure

    Baseline & 6months

Secondary Outcomes (5)

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

    Baseline & 6months

  • Change in dietary habits as measured by questionnaire

    Baseline & 6month

  • Change in weight

    Baseline & 6month

  • Change in amount of physical activity as measured by questionnaire

    Baseline & 6month

  • Change in taking medicine as prescribed

    Baseline& 6month

Study Arms (2)

Intervention Telehealth

EXPERIMENTAL

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.

Behavioral: Telehealth

Control/No Intervention

NO INTERVENTION

Group of subjects that will serve as a comparison group. These subjects will not be approached/enrolled for this study.

Interventions

TelehealthBEHAVIORAL

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.

Intervention Telehealth

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27715, United States

Location

Related Publications (1)

  • 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.

    PMID: 30964439DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Uptal Patel, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 16, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

US(1)