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Mobile Health Technology as an Intervention for Diabetes Self-Management (Care4Life)

Primary Purpose

Type II Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participation in Care4Life
Sponsored by
HealthInsight
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type II Diabetes Mellitus focused on measuring SMS, text, text messages, text messaging, diabetes, diabetes mellitus, type II diabetes, type II diabetes mellitus, type 2 diabetes, type 2 diabetes mellitus, Beacon

Eligibility Criteria

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

Inclusion Criteria:

  • Laboratory test for HbA1c ≥ 8% within the past year
  • Clinical diagnosis of DM
  • Age > 18 years old
  • Patient in a Beacon clinic
  • Cell phone ownership or willingness to acquire a cell phone capable of receiving and sending SMS messages
  • Women who are not pregnant

Exclusion Criteria:

  • Failure to meet inclusion criteria

Sites / Locations

  • Coalville Health Center
  • Pioneer Comprehensive Medical
  • Holladay Family Practice
  • Olympus Clinic
  • Exodus Healthcare - Main Office - Magna
  • Community Health Centers Inc. - 72nd Street Clinic
  • Park City Healthcare, Inc.
  • Riverton Family Health Center
  • Granger Medical-Riverton
  • Wasatch Homeless Health Care - 4th Street Clinic
  • Alpine Internal Medicine
  • HealthInsight
  • Central City Community Health Center Health First Family Medicine
  • Evolutionary Healthcare, Llc
  • Health Clinic Of Utah - SLC
  • Stephen D. Ratcliffe Community Health Center
  • Jordan Ridge Family Medicine
  • Utah Healthcare Institute - St. Mark's Family Medicine
  • Utah Physicians Care Centers - St Mark's Internal Medicine
  • Wasatch Internal Medicine
  • Barbara E. Rizzardi, M.D.
  • Copperview Medical Center, Llc
  • Community Health Centers Inc. - Oquirrh View
  • Advanced Practice Medical Clinic
  • Valley Family Medicine
  • Granger Medical - Jordan Medical Arts
  • Jordan Meadows Medical Center
  • Granger Medical Clinic Inc. - Main Office
  • Kathryn Allen, MD
  • West Valley Family And Preventive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Care4Life

Standard of Care

Arm Description

Text message and online interactive component to help patients with self-management.

Patients enrolled in this arm will receive their normal standard of care from their physician for treatment of type II Diabetes Mellitus.

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c - In control, over time.
Hemoglobin A1c - In control as assessed by laboratory results of blood draw taken from patient's clinic. In control means a result of <9%.

Secondary Outcome Measures

Change in Blood Pressure Control over time
Improved blood pressure (BP) control as demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg)
Change in BMI over time
Lower body mass index (BMI) among users of the SMS-based tool.
Disease Management
Improved knowledge of self-care and disease management practices among adult patients with diabetes treated in Beacon clinics in the Salt Lake Metropolitan Statistical Area (Salt Lake, Tooele, and Summit counties).

Full Information

First Posted
February 28, 2012
Last Updated
September 4, 2012
Sponsor
HealthInsight
Collaborators
Center for Technology and Aging, Voxiva
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1. Study Identification

Unique Protocol Identification Number
NCT01546844
Brief Title
Mobile Health Technology as an Intervention for Diabetes Self-Management
Acronym
Care4Life
Official Title
Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthInsight
Collaborators
Center for Technology and Aging, Voxiva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This purpose of this is study is to evaluate the effectiveness of an interactive mobile health information service, Care4Life, in supporting patient self-management of Type II Diabetes Mellitus.
Detailed Description
This study evaluates the effectiveness of an interactive mobile health information service, Care4Life, in supporting patient self-management through its ability to facilitate patient education, behavior change, and improved adherence with standard care practices. The study population comprises adults who have been diagnosed with Type 2 diabetes mellitus (DM) and a hemoglobin A1c (HbA1c) test above 8% in the past year. All members of the study population are treated at primary care clinics under the auspices of the Utah Beacon Community Program, which aims to improve health through use of health information technology. We will compare outcomes in two groups within this population: patients with DM who enroll in Care4Life (in addition to receiving standard care) to patients with DM who receive standard care from their physician. We will compare these groups both within the clinic and at an aggregated, overall level. This study relies on the use of information and communications technology (ICT) in supporting patient-empowerment strategies. Features of successful diabetes care programs for improving adherence to standards of care, such as the use of diabetes self-management education, checklists that mirror guidelines, and automated reminders are well suited to delivery using an interactive mobile health platform. Research Questions This study will evaluate the efficacy of the Care4Life mHealth program by: Evaluating if a short message service via cell phone texting (SMS) protocol will lead to improvements in clinical, utilization and satisfaction outcomes for patients with DM compared to patient who receive standard care. Evaluating if an SMS protocol can be readily adopted by an adult population in both urban and rural areas with a time-consuming chronic illness. Targeted outcomes include: Improved measures of diabetes control, demonstrated as HbA1c percentage levels ≤ 8%; improved blood pressure (BP) control, demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg); and lower body mass index (BMI) among users of the SMS-based tool. Improved knowledge of self-care and disease management practices among adult patients with diabetes treated in Beacon clinics in the Salt Lake Metropolitan Statistical Area (Salt Lake, Tooele, and Summit counties). Dissemination of results and proof of concept with the broader healthcare community in Utah. The mobile centric diabetes support service at the center of our study is Voxiva's Care4Life platform, which is an interactive mobile application designed to educate participants, encourage behavior change and promote adherence to their prescribed DM treatment protocol. It includes a series of SMS-based tools that have been developed in collaboration with the Instituto Carso de la Salud, located in Mexico. The service sends content relevant to the target participants and their standard treatment protocol. Care4Life delivers an individually tailored diabetes education and management plan based on data that are collected from patients at enrollment and added to the participant's personal health profile. The SMS protocol draws on the experience of a number of interventions that have been independently studied and shown to improve health outcomes. Care4Life functionality consists of the following components: (1) a diabetes diary that can be used to develop a history of glucose levels and trigger alerts and feedback based on the participant's results; (2) health education with content tailored to the participant's health profile; (3) medication adherence reminders and monitoring; (4) medical appointment reminders; (5) a database that allows a participant to record and monitor her/his weight, BMI, blood pressure and laboratory results; and (6) a health portal that allows a participant to review his/her data, obtain advice and guidance based on the information entered, and manage his/her preferences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
SMS, text, text messages, text messaging, diabetes, diabetes mellitus, type II diabetes, type II diabetes mellitus, type 2 diabetes, type 2 diabetes mellitus, Beacon

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care4Life
Arm Type
Experimental
Arm Description
Text message and online interactive component to help patients with self-management.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients enrolled in this arm will receive their normal standard of care from their physician for treatment of type II Diabetes Mellitus.
Intervention Type
Other
Intervention Name(s)
Participation in Care4Life
Other Intervention Name(s)
Voxiva
Intervention Description
Text message service to aid patients with self-management of type II Diabetes Mellitus. Includes online access to patient data and management of health goals.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c - In control, over time.
Description
Hemoglobin A1c - In control as assessed by laboratory results of blood draw taken from patient's clinic. In control means a result of <9%.
Time Frame
3, 6, 9, and 12 months
Secondary Outcome Measure Information:
Title
Change in Blood Pressure Control over time
Description
Improved blood pressure (BP) control as demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg)
Time Frame
3, 6, 9, 12 months
Title
Change in BMI over time
Description
Lower body mass index (BMI) among users of the SMS-based tool.
Time Frame
3, 6, 9, 12 months
Title
Disease Management
Description
Improved knowledge of self-care and disease management practices among adult patients with diabetes treated in Beacon clinics in the Salt Lake Metropolitan Statistical Area (Salt Lake, Tooele, and Summit counties).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laboratory test for HbA1c ≥ 8% within the past year Clinical diagnosis of DM Age > 18 years old Patient in a Beacon clinic Cell phone ownership or willingness to acquire a cell phone capable of receiving and sending SMS messages Women who are not pregnant Exclusion Criteria: Failure to meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Woolsey, MD
Organizational Affiliation
HealthInsight
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Korey Cappoza, MPH
Organizational Affiliation
HealthInsight
Official's Role
Study Director
Facility Information:
Facility Name
Coalville Health Center
City
Coalville
State/Province
Utah
ZIP/Postal Code
84017
Country
United States
Facility Name
Pioneer Comprehensive Medical
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Holladay Family Practice
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Olympus Clinic
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Exodus Healthcare - Main Office - Magna
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Community Health Centers Inc. - 72nd Street Clinic
City
Midvale
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Facility Name
Park City Healthcare, Inc.
City
Park City
State/Province
Utah
ZIP/Postal Code
84068
Country
United States
Facility Name
Riverton Family Health Center
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
Granger Medical-Riverton
City
Riverton
State/Province
Utah
ZIP/Postal Code
84096
Country
United States
Facility Name
Wasatch Homeless Health Care - 4th Street Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Facility Name
Alpine Internal Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
HealthInsight
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Central City Community Health Center Health First Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84111
Country
United States
Facility Name
Evolutionary Healthcare, Llc
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84111
Country
United States
Facility Name
Health Clinic Of Utah - SLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84115
Country
United States
Facility Name
Stephen D. Ratcliffe Community Health Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84116
Country
United States
Facility Name
Jordan Ridge Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Utah Healthcare Institute - St. Mark's Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Utah Physicians Care Centers - St Mark's Internal Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Wasatch Internal Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Barbara E. Rizzardi, M.D.
City
Sandy
State/Province
Utah
ZIP/Postal Code
84093
Country
United States
Facility Name
Copperview Medical Center, Llc
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Community Health Centers Inc. - Oquirrh View
City
Taylorsville
State/Province
Utah
ZIP/Postal Code
84118
Country
United States
Facility Name
Advanced Practice Medical Clinic
City
Tooele
State/Province
Utah
ZIP/Postal Code
84074
Country
United States
Facility Name
Valley Family Medicine
City
Tooele
State/Province
Utah
ZIP/Postal Code
84074
Country
United States
Facility Name
Granger Medical - Jordan Medical Arts
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Jordan Meadows Medical Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Granger Medical Clinic Inc. - Main Office
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Kathryn Allen, MD
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
West Valley Family And Preventive Medicine
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States

12. IPD Sharing Statement

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Mobile Health Technology as an Intervention for Diabetes Self-Management

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