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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Center for Technology and Aging
Voxiva
Information provided by (Responsible Party):
HealthInsight
ClinicalTrials.gov Identifier:
NCT01546844
First received: February 28, 2012
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Type II Diabetes Mellitus
Other: Participation in Care4Life

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management

Resource links provided by NLM:


Further study details as provided by HealthInsight:

Primary Outcome Measures:
  • Change in Hemoglobin A1c - In control, over time. [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Hemoglobin A1c - In control as assessed by laboratory results of blood draw taken from patient's clinic. In control means a result of <9%.


Secondary Outcome Measures:
  • Change in Blood Pressure Control over time [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Improved blood pressure (BP) control as demonstrated as BP ≤ 140/90 millimeters mercury (mm Hg)

  • Change in BMI over time [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Lower body mass index (BMI) among users of the SMS-based tool.

  • Disease Management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546844

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

No publications provided

Responsible Party: HealthInsight
ClinicalTrials.gov Identifier: NCT01546844     History of Changes
Other Study ID Numbers: Care4Life Grant
Study First Received: February 28, 2012
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by HealthInsight:
SMS
text
text messages
text messaging
diabetes
diabetes mellitus
type II diabetes
type II diabetes mellitus
type 2 diabetes
type 2 diabetes mellitus
Beacon

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014