Clinical trial NCT01546844: Mobile Health Technology as an Intervention for Diabetes Self-Management
Official title: Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: HealthInsight
Sponsor class: OTHER
Collaborators: name: Center for Technology and Aging
name: Voxiva
First posted: 2012-03-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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

Primary outcomes:
measure: Change in Hemoglobin A1c - In control, over time.
timeFrame: 3, 6, 9, and 12 months
Secondary outcomes:
measure: Change in Blood Pressure Control over time
timeFrame: 3, 6, 9, 12 months
measure: Change in BMI over time
timeFrame: 3, 6, 9, 12 months
measure: Disease Management
timeFrame: 12 months
Other outcomes:
Locations:
city: Coalville
country: United States
facility: Coalville Health Center
state: Utah
city: Draper
country: United States
facility: Pioneer Comprehensive Medical
state: Utah
city: Holladay
country: United States
facility: Holladay Family Practice
state: Utah
city: Holladay
country: United States
facility: Olympus Clinic
state: Utah
city: Magna
country: United States
facility: Exodus Healthcare - Main Office - Magna
state: Utah
city: Midvale
country: United States
facility: Community Health Centers Inc. - 72nd Street Clinic
state: Utah
city: Park City
country: United States
facility: Park City Healthcare, Inc.
state: Utah
city: Riverton
country: United States
facility: Riverton Family Health Center
state: Utah
city: Riverton
country: United States
facility: Granger Medical-Riverton
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Homeless Health Care - 4th Street Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Alpine Internal Medicine
state: Utah
city: Salt Lake City
country: United States
facility: HealthInsight
state: Utah
city: Salt Lake City
country: United States
facility: Central City Community Health Center Health First Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Evolutionary Healthcare, Llc
state: Utah
city: Salt Lake City
country: United States
facility: Health Clinic Of Utah - SLC
state: Utah
city: Salt Lake City
country: United States
facility: Stephen D. Ratcliffe Community Health Center
state: Utah
city: Salt Lake City
country: United States
facility: Jordan Ridge Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Utah Healthcare Institute - St. Mark's Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Utah Physicians Care Centers - St Mark's Internal Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Internal Medicine
state: Utah
city: Sandy
country: United States
facility: Barbara E. Rizzardi, M.D.
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center, Llc
state: Utah
city: Taylorsville
country: United States
facility: Community Health Centers Inc. - Oquirrh View
state: Utah
city: Tooele
country: United States
facility: Advanced Practice Medical Clinic
state: Utah
city: Tooele
country: United States
facility: Valley Family Medicine
state: Utah
city: West Jordan
country: United States
facility: Granger Medical - Jordan Medical Arts
state: Utah
city: West Jordan
country: United States
facility: Jordan Meadows Medical Center
state: Utah
city: West Valley City
country: United States
facility: Granger Medical Clinic Inc. - Main Office
state: Utah
city: West Valley City
country: United States
facility: Kathryn Allen, MD
state: Utah
city: West Valley City
country: United States
facility: West Valley Family And Preventive Medicine
state: Utah
Study officials:
affiliation: HealthInsight
name: Sarah Woolsey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthInsight
name: Korey Cappoza, MPH
role: STUDY_DIRECTOR
References: