NCT01546844

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

30 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

9 months

First QC Date

February 28, 2012

Last Update Submit

September 4, 2012

Conditions

Keywords

SMStexttext messagestext messagingdiabetesdiabetes mellitustype II diabetestype II diabetes mellitustype 2 diabetestype 2 diabetes mellitusBeacon

Outcome Measures

Primary Outcomes (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%.

    3, 6, 9, and 12 months

Secondary Outcomes (3)

  • Change in Blood Pressure Control over time

    3, 6, 9, 12 months

  • Change in BMI over time

    3, 6, 9, 12 months

  • Disease Management

    12 months

Study Arms (2)

Care4Life

EXPERIMENTAL

Text message and online interactive component to help patients with self-management.

Other: Participation in Care4Life

Standard of Care

NO INTERVENTION

Patients enrolled in this arm will receive their normal standard of care from their physician for treatment of type II Diabetes Mellitus.

Interventions

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.

Also known as: Voxiva
Care4Life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Coalville Health Center

Coalville, Utah, 84017, United States

Location

Pioneer Comprehensive Medical

Draper, Utah, 84020, United States

Location

Holladay Family Practice

Holladay, Utah, 84117, United States

Location

Olympus Clinic

Holladay, Utah, 84117, United States

Location

Exodus Healthcare - Main Office - Magna

Magna, Utah, 84044, United States

Location

Community Health Centers Inc. - 72nd Street Clinic

Midvale, Utah, 84115, United States

Location

Park City Healthcare, Inc.

Park City, Utah, 84068, United States

Location

Riverton Family Health Center

Riverton, Utah, 84065, United States

Location

Granger Medical-Riverton

Riverton, Utah, 84096, United States

Location

Wasatch Homeless Health Care - 4th Street Clinic

Salt Lake City, Utah, 84101, United States

Location

Alpine Internal Medicine

Salt Lake City, Utah, 84102, United States

Location

HealthInsight

Salt Lake City, Utah, 84107, United States

Location

Central City Community Health Center Health First Family Medicine

Salt Lake City, Utah, 84111, United States

Location

Evolutionary Healthcare, Llc

Salt Lake City, Utah, 84111, United States

Location

Health Clinic Of Utah - SLC

Salt Lake City, Utah, 84115, United States

Location

Stephen D. Ratcliffe Community Health Center

Salt Lake City, Utah, 84116, United States

Location

Jordan Ridge Family Medicine

Salt Lake City, Utah, 84123, United States

Location

Utah Healthcare Institute - St. Mark's Family Medicine

Salt Lake City, Utah, 84124, United States

Location

Utah Physicians Care Centers - St Mark's Internal Medicine

Salt Lake City, Utah, 84124, United States

Location

Wasatch Internal Medicine

Salt Lake City, Utah, 84124, United States

Location

Barbara E. Rizzardi, M.D.

Sandy City, Utah, 84093, United States

Location

Copperview Medical Center, Llc

South Jordan, Utah, 84095, United States

Location

Community Health Centers Inc. - Oquirrh View

Taylorsville, Utah, 84118, United States

Location

Advanced Practice Medical Clinic

Tooele, Utah, 84074, United States

Location

Valley Family Medicine

Tooele, Utah, 84074, United States

Location

Granger Medical - Jordan Medical Arts

West Jordan, Utah, 84088, United States

Location

Jordan Meadows Medical Center

West Jordan, Utah, 84088, United States

Location

Granger Medical Clinic Inc. - Main Office

West Valley City, Utah, 84120, United States

Location

Kathryn Allen, MD

West Valley City, Utah, 84120, United States

Location

West Valley Family And Preventive Medicine

West Valley City, Utah, 84120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sarah Woolsey, MD

    HealthInsight

    PRINCIPAL INVESTIGATOR
  • Korey Cappoza, MPH

    HealthInsight

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 7, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations