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Impact of Web-based Care Management for Poorly Controlled Type 2 Diabetes Mellitus: a Randomized, Controlled Trial

Primary Purpose

Type 2 Diabetes Mellitus

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes software and device
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, web-based, software, device

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Receiving care from a PCP at the specified KPGA medical centers
  • 18-74 years of age
  • Type 2 Diabetes Mellitus (DM)
  • Treated with insulin or willing to start insulin therapy
  • Most recent HbA1c in the previous 12 months ≥ 9%
  • Internet capability
  • Actively enrolled or willing to enroll on www.kp.org
  • English speaking

Exclusion Criteria:

  • Having received care from an endocrinology specialty physician or Hospice/ Palliative Care within the last 3 months
  • Enrolled in another research study
  • Using an insulin pump
  • Type 1 DM

Sites / Locations

  • Kaiser Permanente Georgia Region

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Diabetes care with primary care practitioner supplemented with clinical pharmacy specialist

Diabetes care with primary care practitioner and clinical pharmacy specialist, with the aid of a diabetes software and device to upload glucometer results from home

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c

Secondary Outcome Measures

Hemoglobin A1c<9
Office visit time
time spent with participants during office visit

Full Information

First Posted
September 24, 2013
Last Updated
March 18, 2014
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT01960062
Brief Title
Impact of Web-based Care Management for Poorly Controlled Type 2 Diabetes Mellitus: a Randomized, Controlled Trial
Official Title
Impact of Web-based Care Management for Poorly Controlled Type 2 Diabetes Mellitus: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
no potential participants met the inclusion criteria
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Between October 1 and November 30, 2011, participants will be enrolled in this study comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32 people (16 per group) will participate in the study. Once eligible patients are found, they will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care with the CPS plus web-based care using the MyLink software. Participants using the software will agree to upload their glucometer measurements using the software every 2- 4 weeks. Following the receipt of the glucometer data, either electronically from intervention group participants or verbally from the control group participants, medications/ doses will be adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups will receive a follow-up HbA1c 2-4 months after enrollment to see if there were any significant changes in HbA1c between groups.
Detailed Description
Diabetes is an increasingly important public health issue. The American Diabetes Association estimates that 25.8 million people in the United States (8% of the total population) currently have diabetes. In fact, it is estimated that as many as 30.3 million Americans will have the disease by the year 2030. Concurrently, the economic impact of diabetes is rising at an alarming rate. In 2007, all costs associated with diabetes totaled $174 billion; $116 billion was spent on direct medical costs. Diabetes is associated with significant morbidity and mortality, a leading cause of blindness, kidney failure, stroke, and cardiovascular death. Given the chronically progressive nature of diabetes, controlling the disease and preventing or delaying complications necessitates constant communication between the patient and the provider. Diabetes care limited to clinic visits does not meet the needs of many patients. With the increasing diabetes burden, there is an unmet need for innovative care methods. The internet's widespread availability has paved the way for increased utilization of web-based care management programs to manage chronic diseases such as diabetes mellitus. A few randomized controlled trials have evaluated the use of web-based care in diabetes. These trials, ranging from 3 months to 30 months, have shown favorable changes in Hemoglobin A1c (HbA1c), as well as patient and provider satisfaction. A web-based application called MyLink has been used and evaluated in some Kaiser Permanente regions with impressive differences in HbA1c between groups utilizing web-based care versus usual care. This tool, along with appropriate software, enables patients to upload glucometer results from home, to the care provider in the office. Patients are able to view trends on their computer screen to see how lifestyle activities affect their blood sugar. The primary objective of this study is to evaluate the potential role of the MyLink web-based care management program in improving diabetes-related measures. It is expected that participants using web-based care will achieve a greater improvement in HbA1c than patients receiving usual care from the Clinical Pharmacy Specialist (CPS). Between October 1 and November 30, 2011, participants will be enrolled in this study comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32 people (16 per group) will participate in the study. Once eligible patients are found, they will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care with the CPS plus web-based care using the MyLink software. Participants using the software will agree to upload their glucometer measurements using the software every 2- 4 weeks. Following the receipt of the glucometer data, either electronically from intervention group participants or verbally from the control group participants, medications/ doses will be adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups will receive a follow-up HbA1c 2-4 months after enrollment to see if there were any significant changes in HbA1c between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, web-based, software, device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Diabetes care with primary care practitioner supplemented with clinical pharmacy specialist
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Diabetes care with primary care practitioner and clinical pharmacy specialist, with the aid of a diabetes software and device to upload glucometer results from home
Intervention Type
Device
Intervention Name(s)
Diabetes software and device
Intervention Description
USB cord, CD-rom, and application to allow communication with provider
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1c<9
Time Frame
2-4 months
Title
Office visit time
Description
time spent with participants during office visit
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receiving care from a PCP at the specified KPGA medical centers 18-74 years of age Type 2 Diabetes Mellitus (DM) Treated with insulin or willing to start insulin therapy Most recent HbA1c in the previous 12 months ≥ 9% Internet capability Actively enrolled or willing to enroll on www.kp.org English speaking Exclusion Criteria: Having received care from an endocrinology specialty physician or Hospice/ Palliative Care within the last 3 months Enrolled in another research study Using an insulin pump Type 1 DM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Yates, PharmD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Georgia Region
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Impact of Web-based Care Management for Poorly Controlled Type 2 Diabetes Mellitus: a Randomized, Controlled Trial

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