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.
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
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:
- 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.
- Conditions
- Type II Diabetes Mellitus
- 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 group | Role | What they receive |
|---|---|---|
| Care4Life | Experimental | Text message and online interactive component to help patients with self-management. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Change in BMI over time
Lower body mass index (BMI) among users of the SMS-based tool.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- HealthInsight
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Technology and Aging, Voxiva
- Responsible party
- Sponsor
- Investigators
- Sarah Woolsey, MD, Principal investigator, HealthInsightKorey Cappoza, MPH, Study director, HealthInsight
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mobile Health Technology as an Intervention for Type II Diabetes Self-Management
- ClinicalTrials.gov ID
- NCT01546844
- Acronym / sponsor ID
- Care4Life / Care4Life Grant
- Conditions
- Type II Diabetes Mellitus
- Keywords
- SMS, text, text messages, text messaging, diabetes, diabetes mellitus, type II diabetes, type II diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- HealthInsightUniversity, hospital or other
- Collaborators
- Center for Technology and Aging, Voxiva
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care4Life | Experimental | Other: Participation in Care4LifeText message and online interactive component to help patients with self-management. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in Care4LifeAlso: VoxivaText 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 | Care4Life |
Primary outcome
Change in Hemoglobin A1c - In control, over time.
Time frame: 3, 6, 9, and 12 months
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 secondary outcomes
Change in Blood Pressure Control over time
Time frame: 3, 6, 9, 12 months
Change in BMI over time
Time frame: 3, 6, 9, 12 months
Disease Management
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Woolsey, MD principal investigator
HealthInsight
Korey Cappoza, MPH study director
HealthInsight
30 sites in 1 country: see every site and its status.
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.