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

September 4, 2012 updated by: HealthInsight

Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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:

  1. 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.
  2. 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).
  3. 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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Coalville, Utah, United States, 84017
        • Coalville Health Center
      • Draper, Utah, United States, 84020
        • Pioneer Comprehensive Medical
      • Holladay, Utah, United States, 84117
        • Holladay Family Practice
      • Holladay, Utah, United States, 84117
        • Olympus Clinic
      • Magna, Utah, United States, 84044
        • Exodus Healthcare - Main Office - Magna
      • Midvale, Utah, United States, 84115
        • Community Health Centers Inc. - 72nd Street Clinic
      • Park City, Utah, United States, 84068
        • Park City Healthcare, Inc.
      • Riverton, Utah, United States, 84065
        • Riverton Family Health Center
      • Riverton, Utah, United States, 84096
        • Granger Medical-Riverton
      • Salt Lake City, Utah, United States, 84101
        • Wasatch Homeless Health Care - 4th Street Clinic
      • Salt Lake City, Utah, United States, 84102
        • Alpine Internal Medicine
      • Salt Lake City, Utah, United States, 84107
        • HealthInsight
      • Salt Lake City, Utah, United States, 84111
        • Central City Community Health Center Health First Family Medicine
      • Salt Lake City, Utah, United States, 84111
        • Evolutionary Healthcare, Llc
      • Salt Lake City, Utah, United States, 84115
        • Health Clinic Of Utah - SLC
      • Salt Lake City, Utah, United States, 84116
        • Stephen D. Ratcliffe Community Health Center
      • Salt Lake City, Utah, United States, 84123
        • Jordan Ridge Family Medicine
      • Salt Lake City, Utah, United States, 84124
        • Utah Healthcare Institute - St. Mark's Family Medicine
      • Salt Lake City, Utah, United States, 84124
        • Utah Physicians Care Centers - St Mark's Internal Medicine
      • Salt Lake City, Utah, United States, 84124
        • Wasatch Internal Medicine
      • Sandy, Utah, United States, 84093
        • Barbara E. Rizzardi, M.D.
      • South Jordan, Utah, United States, 84095
        • Copperview Medical Center, Llc
      • Taylorsville, Utah, United States, 84118
        • Community Health Centers Inc. - Oquirrh View
      • Tooele, Utah, United States, 84074
        • Advanced Practice Medical Clinic
      • Tooele, Utah, United States, 84074
        • Valley Family Medicine
      • West Jordan, Utah, United States, 84088
        • Granger Medical - Jordan Medical Arts
      • West Jordan, Utah, United States, 84088
        • Jordan Meadows Medical Center
      • West Valley City, Utah, United States, 84120
        • Granger Medical Clinic Inc. - Main Office
      • West Valley City, Utah, United States, 84120
        • Kathryn Allen, MD
      • West Valley City, Utah, United States, 84120
        • West Valley Family And Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Care4Life
Text message and online interactive component to help patients with self-management.
Other: Participation in Care4Life
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.
Other Names:
  • Voxiva
NO_INTERVENTION: Standard of Care
Patients enrolled in this arm will receive their normal standard of care from their physician for treatment of type II Diabetes Mellitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c - In control, over time.
Time Frame: 3, 6, 9, and 12 months
Hemoglobin A1c - In control as assessed by laboratory results of blood draw taken from patient's clinic. In control means a result of <9%.
3, 6, 9, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure Control over time
Time Frame: 3, 6, 9, 12 months
Improved blood pressure (BP) control as demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg)
3, 6, 9, 12 months
Change in BMI over time
Time Frame: 3, 6, 9, 12 months
Lower body mass index (BMI) among users of the SMS-based tool.
3, 6, 9, 12 months
Disease Management
Time Frame: 12 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthInsight

Collaborators

Center for Technology and Aging
Voxiva

Investigators

  • Principal Investigator: Sarah Woolsey, MD, HealthInsight
  • Study Director: Korey Cappoza, MPH, HealthInsight

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Care4Life Grant

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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