Mobile Health Technology as an Intervention for Diabetes Self-Management

Type II Diabetes Mellitus Clinical Trial

— Care4Life  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01546844
• Other study ID #: Care4Life Grant
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 28, 2012
• Last updated: September 4, 2012
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2012
• Source: HealthInsight
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
HealthInsight	Center for Technology and Aging, Voxiva

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	3, 6, 9, and 12 months	No
Secondary	Change in Blood Pressure Control over time	Improved blood pressure (BP) control as demonstrated as BP = 140/90 millimeters mercury (mm Hg)	3, 6, 9, 12 months	No
Secondary	Change in BMI over time	Lower body mass index (BMI) among users of the SMS-based tool.	3, 6, 9, 12 months	No
Secondary	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).	12 months	No