DiabetesNCT02726217
NYULMC CareSmarts Pilot
A study testing CareSmarts Mobile Health Diabetes Program in people with Diabetes and Type 2 Diabetes (T2D), run by NYU Langone Health at 1 site in United States.
Trial summary
CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 2 Diabetes (T2D)
- What is being tested?
- CareSmarts Mobile Health Diabetes Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 2 May 2017
- 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
- have a DRG Code of T2D, and be prescribed at least one oral T2D drug and/or insulin.
- must own an SMS capable mobile device and be willing to send and receive SMS messages regarding T2D self-management.
- The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that targets an HbA1c <7%.
Who cannot join
- unable or unwilling to provide informed consent
- unable to participate meaningfully in an intervention that involves use of SMS messages (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking)
- unwilling to accept randomization assignment
- pregnant, plans to become pregnant in the next 6 months, or who become pregnant during the study
- gestational diabetes
- breastfeedling
- individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: NYULMC-CareSmarts Study: A Pilot Study to Determine the Feasibility, Acceptability, and Potential Efficacy of an SMS-based Mobile Intervention to Enhance Type 2 Diabetes Self-management
CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Individuals will be randomly assigned with equal allocation to either the CareSmarts intervention or to usual care for 6 months.
Read the detailed description
CareSmarts is a mobile diabetes program that provides self-management support and team-based care management for people with diabetes through automated SMS messages. The program is a theory-driven behavioral intervention designed to improve self-care through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Participants in the program receive educational and motivational text messages about diabetes self-care, some prompts to engage in a particular action (for example, "Time to check your blood sugar"), and some self-assessment questions (such as, "Do you need refills of any of your medications?") to which the patient responds by texting. Participants' responses to self-assessment questions are used to facilitate remote monitoring and care management by the health care team. A response that is outside established parameters triggers an alert. Using protocols, nurses respond to each alert by the next business day.
- Conditions
- Diabetes, Type 2 Diabetes (T2D)
- Being tested
- CareSmarts Mobile Health Diabetes Program, Standard of Care Reminders and Self Assessments
- Keywords
- CareSmarts, SMS-based mobile
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareSmarts Mobile Health Diabetes ProgramBehavioural
Nurses from Diabetes Clinic will use a web-based enrollment form that includes the patient's mobile phone number, diabetes care plan, and preferred times for receiving messages. Participants in the program receive text messages about diabetes self-care. The contents of the messages that the participants receive are modified through software every two weeks as needed, based on their interactions with the system. Participants follow a flexible education curriculum in which they move from one topic to the next at their own pace.
Standard of Care Reminders and Self AssessmentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CareSmarts Intervention | Experimental | Participants in the program receive text messages about diabetes self-care Receives: Behavioral: CareSmarts Mobile Health Diabetes Program; Behavioral: Standard of Care Reminders and Self Assessments |
| Control | Active comparator | Standard of Care reminders and assessments for individuals with Diabetes Receives: Behavioral: Standard of Care Reminders and Self Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of glucose
Measured: 3 Months
Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Measured: 3 Months
Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
Measured: 3 Months
Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start1 Mar 2016
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Sevick, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726217
- Sponsor's protocol ID
- 15-00923
- Status last verified
- May 2017
- First submitted
- 29 Mar 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYULMC-CareSmarts Study: A Pilot Study to Determine the Feasibility, Acceptability, and Potential Efficacy of an SMS-based Mobile Intervention to Enhance Type 2 Diabetes Self-management
- ClinicalTrials.gov ID
- NCT02726217
- Acronym / sponsor ID
- 15-00923
- Conditions
- Diabetes, Type 2 Diabetes (T2D)
- Keywords
- CareSmarts, SMS-based mobile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 1 Apr 2016 (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.
CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Individuals will be randomly assigned with equal allocation to either the CareSmarts intervention or to usual care for 6 months.
Detailed description
CareSmarts is a mobile diabetes program that provides self-management support and team-based care management for people with diabetes through automated SMS messages. The program is a theory-driven behavioral intervention designed to improve self-care through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Participants in the program receive educational and motivational text messages about diabetes self-care, some prompts to engage in a particular action (for example, "Time to check your blood sugar"), and some self-assessment questions (such as, "Do you need refills of any of your medications?") to which the patient responds by texting. Participants' responses to self-assessment questions are used to facilitate remote monitoring and care management by the health care team. A response that is outside established parameters triggers an alert. Using protocols, nurses respond to each alert by the next business day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CareSmarts Intervention | Experimental | Behavioral: CareSmarts Mobile Health Diabetes Program, Behavioral: Standard of Care Reminders and Self AssessmentsParticipants in the program receive text messages about diabetes self-care |
| Control | Active comparator | Behavioral: Standard of Care Reminders and Self AssessmentsStandard of Care reminders and assessments for individuals with Diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have a DRG Code of T2D, and be prescribed at least one oral T2D drug and/or insulin.
- must own an SMS capable mobile device and be willing to send and receive SMS messages regarding T2D self-management.
- The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that targets an HbA1c <7%.
Key exclusion criteria (7 listed)
- unable or unwilling to provide informed consent
- unable to participate meaningfully in an intervention that involves use of SMS messages (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking)
- unwilling to accept randomization assignment
- pregnant, plans to become pregnant in the next 6 months, or who become pregnant during the study
- gestational diabetes
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 |
|---|---|---|
| CareSmarts Mobile Health Diabetes ProgramNurses from Diabetes Clinic will use a web-based enrollment form that includes the patient's mobile phone number, diabetes care plan, and preferred times for receiving messages. Participants in the program receive text messages about diabetes self-care. The contents of the messages that the participants receive are modified through software every two weeks as needed, based on their interactions with the system. Participants follow a flexible education curriculum in which they move from one topic to the next at their own pace. | Behavioural | CareSmarts Intervention |
| Standard of Care Reminders and Self Assessments | Behavioural | CareSmarts Intervention, Control |
Primary outcome
Measure of glucose
Time frame: 3 Months
Satisfaction with Care measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time frame: 3 Months
Adherence to the diabetes self-management regimen using the Diabetes Self Management Questionnaire (DSMQ).
Time frame: 3 Months
Acceptability of the intervention protocol will be evaluated using a satisfaction survey.
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
Mary Sevick, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareSmarts Mobile Health Diabetes Program in people with Diabetes and Type 2 Diabetes (T2D), run by NYU Langone Health at 1 site 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of glucose (time frame: 3 Months). The study lists 4 primary outcomes in all. 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 May 2017.