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Type II Diabetes MellitusCare4LifeNCT01546844

Mobile Health Technology as an Intervention for Diabetes Self-Management

A study testing Participation in Care4Life in people with Type II Diabetes Mellitus, run by HealthInsight at 30 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
Participation in Care4Life
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
30 sitesUnited States
Study dates
Mar 2012to Feb 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Failure to meet inclusion criteria

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites
  • Coalville Health Center

    Coalville, Utah, 84017

  • Pioneer Comprehensive Medical

    Draper, Utah, 84020

  • Holladay Family Practice

    Holladay, Utah, 84117

  • Olympus Clinic

    Holladay, Utah, 84117

  • Exodus Healthcare - Main Office - Magna

    Magna, Utah, 84044

  • Community Health Centers Inc. - 72nd Street Clinic

    Midvale, Utah, 84115

  • Park City Healthcare, Inc.

    Park City, Utah, 84068

  • Riverton Family Health Center

    Riverton, Utah, 84065

  • Granger Medical-Riverton

    Riverton, Utah, 84096

  • Wasatch Homeless Health Care - 4th Street Clinic

    Salt Lake City, Utah, 84101

  • Alpine Internal Medicine

    Salt Lake City, Utah, 84102

  • HealthInsight

    Salt Lake City, Utah, 84107

  • Central City Community Health Center Health First Family Medicine

    Salt Lake City, Utah, 84111

  • Evolutionary Healthcare, Llc

    Salt Lake City, Utah, 84111

  • Health Clinic Of Utah - SLC

    Salt Lake City, Utah, 84115

  • Stephen D. Ratcliffe Community Health Center

    Salt Lake City, Utah, 84116

  • Jordan Ridge Family Medicine

    Salt Lake City, Utah, 84123

  • Utah Healthcare Institute - St. Mark's Family Medicine

    Salt Lake City, Utah, 84124

  • Utah Physicians Care Centers - St Mark's Internal Medicine

    Salt Lake City, Utah, 84124

  • Wasatch Internal Medicine

    Salt Lake City, Utah, 84124

  • Barbara E. Rizzardi, M.D.

    Sandy City, Utah, 84093

  • Copperview Medical Center, Llc

    South Jordan, Utah, 84095

  • Community Health Centers Inc. - Oquirrh View

    Taylorsville, Utah, 84118

  • Advanced Practice Medical Clinic

    Tooele, Utah, 84074

  • Valley Family Medicine

    Tooele, Utah, 84074

  • Granger Medical - Jordan Medical Arts

    West Jordan, Utah, 84088

  • Jordan Meadows Medical Center

    West Jordan, Utah, 84088

  • Granger Medical Clinic Inc. - Main Office

    West Valley City, Utah, 84120

  • Kathryn Allen, MD

    West Valley City, Utah, 84120

  • West Valley Family And Preventive Medicine

    West Valley City, Utah, 84120

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Participation in Care4Life
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
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Participation in Care4LifeOther

    Also called Voxiva

    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.

Study groups in NCT01546844
Study groupRoleWhat they receive
Care4LifeExperimentalText message and online interactive component to help patients with self-management.
Receives: Other: Participation in Care4Life
Standard of CareNo interventionPatients enrolled in this arm will receive their normal standard of care from their physician for treatment of type II Diabetes Mellitus.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: 3, 6, 9, and 12 months

Secondary outcomes (3)
  1. Change in Blood Pressure Control over time

    Improved blood pressure (BP) control as demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg)

    Measured: 3, 6, 9, 12 months

  2. Change in BMI over time

    Lower body mass index (BMI) among users of the SMS-based tool.

    Measured: 3, 6, 9, 12 months

  3. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2012 (estimated)
  4. Study completionFeb 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546844
Sponsor's protocol ID
Care4Life Grant
Acronym
Care4Life
Status last verified
Sep 2012
First submitted
28 Feb 2012
Last updated
5 Sep 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Participation in Care4Life in people with Type II Diabetes Mellitus, run by HealthInsight at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c - In control, over time. (time frame: 3, 6, 9, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.

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