Mobile Health Technology as an Intervention for Diabetes Self-Management (Care4Life)
This study is enrolling participants by invitation only.
Sponsor:
HealthInsight
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
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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
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 May 21, 2013