Mobile Health Technology as an Intervention for Diabetes Self-Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Other: Participation in Care4Life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care4Life<br>Text message and online interactive component to help patients with self-management. | Other: Participation in Care4Life<br>* 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.<br>* Other names: Voxiva;|
| No Intervention: Standard of Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in BMI over time | Lower body mass index (BMI) among users of the SMS-based tool. | 3, 6, 9, 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMS, text, text messages, text messaging, diabetes, diabetes mellitus, type II diabetes, type II diabetes mellitus, type 2 diabetes, type 2 diabetes mellitus, Beacon