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Diabetes Mellitus, Type 2DM-BOOSTNCT04710940

Development and Feasibility Testing of DM-BOOST Intervention.

A study testing Diabetes BOOST in people with Diabetes Mellitus, Type 2, run by Daniel Amante at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

DM-BOOST uses clinical informatics tools to identify types of patients with gaps in diabetes care and deploy tailored, proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Diabetes BOOST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
13 Jan 2021to 1 Jan 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults (age 18+)
  • Cognitively able to consent (Aims 2 and 3)
  • Diagnosed with type 2 diabetes (Aims 1-3)
  • Receive primary care at UMMHC in past 12 months at time of initial analysis (Aims 1-3)
  • English speaking (Aims 2 and 3)
  • Have access to patient portal or a smart phone (Aim 3)

Who cannot join

  • Adults unable to consent (lacking cognitive capacity) (Aims 2 and 3)
  • Individuals who are not yet adults (infants, children, teenagers) (Aims 1-3)
  • Pregnant women (Aims 1-3)
  • Prisoners (Aims 1-3)
  • Non-English speaking (Aims 2 and 3)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Development and Feasibility Testing of a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology.

DM-BOOST uses clinical informatics tools to identify types of patients with gaps in diabetes care and deploy tailored, proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance longitudinal patient self-management support.

Read the detailed description

In DM-BOOST, the Principal investigator will deploy a mixed-methods, patient-centered approach to intervention development and initiate a multiphase optimization strategy (MOST) to learn how to maximize patient engagement and support of self-management training. In this pilot, study team will complete the first phase (Preparation), and initiate feasibility piloting of the second phase (Optimization). Completion of optimization and MOST's final phase (Evaluation), will occur in a subsequent project.

In the preparation phase, Principal investigator will first analyze EHR and claims data in the UMCCTS data lake to identify sociodemographic characteristics associated with gaps in diabetes care to develop patient persona archetypes (Aim 1). Next, Principal investigator will selectively recruit patients of identified persona types as consultants, elicit stakeholder feedback during community engagement studios and conduct usability testing to iteratively design the intervention (Aim 2). Study team will then conduct a feasibility pilot (Aim 3) to assess user experience of the intervention implementation and collect exploratory outcome data to be used to inform a subsequent, complete optimization trial.

Being tested
Diabetes BOOST, Usual Care
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes BOOSTBehavioural

    Participants will receive supportive care using technology for DSMT in addition to usual care.

  • Usual CareBehavioural

    Participants will receive usual care for DSMT.

Study groups in NCT04710940
Study groupRoleWhat they receive
Intervention - Diabetes BOOSTExperimentalIntervention group participants will complete a baseline survey, receive a referral to DSMT from the research team, a mailed welcome letter and self-care education sent via a series of personalized patient portal secure messages, text messages, and video call. They will be sent text messages with information about one of the American Association of Diabetes Educators 7 self-care behaviors and will receive encouragement to author their own self-management behavioral goals. Participants will also complete a telehealth training video call with research staff and review the goals that the participant replied with. The participant will then be encouraged to send a patient portal message to their DSMT CDCES that includes their personalized goals prior to their scheduled DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.
Receives: Behavioral: Diabetes BOOST
Usual CareActive comparatorComparison Group participants will complete a baseline survey, receive a DSMT referral request from research team to their primary care provider and a mailed welcome letter. The mailed letter will welcome the participant to the study and contain general information about diabetes self-care behaviors and goal setting. They will complete a DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention Acceptability (Aim 2)

    Patient-reported assessment of intervention acceptability via usability testing. Qualitative data collection informed by the Technology Acceptance Model with assessment of perceived usefulness, ease of use, behavioral intention to use and external factors. No quantitative data measured.

    Measured: 1 month

  2. Completion of diabetes self-management training (Aim 3)

    Completion of diabetes self-management training.

    Measured: 9 months

Secondary outcomes (6)

  1. Clinical utilization (Aim 3)

    Rate of clinical utilization as measured by number of visits per participant to primary, specialty care, and emergency/hospital care visits measured 6-months after follow-up visit.

    Measured: 9 months

  2. Diabetes self-efficacy (Aim 3)

    Diabetes self efficacy will be measured at baseline and 3 months after enrolling in the study using the Diabetes Management Self-Efficacy Scale. Participants will provide feedback on set of questions, using a 5-point Likert scale( with 1=Strong Disagree, 2=Somewhat Disagree, 3= Neutral, 4=Somewhat Agree, 5= Strongly Agree)

    Measured: 3 months

  3. Diabetes treatment satisfaction (Aim 3)

    Diabetes Treatment Satisfaction will be measured at 3 months after enrolling in the study using the Diabetes Treatment Satisfaction Questionnaire Change tool. Participants will be asked to share how their experience of current treatment has changed from their experience of treatment before the study began. They will answer each question by choosing 3 for Much More Satisfied Now up to -3 for Much Less Satisfied Now. (3,2,1,0,-1,-2,-3)

    Measured: 3 months

  4. Diabetes self-management skills (Aim 3)

    Self-management skills will be measured at 3 months after enrolling in the study. Participant will be asked questions about their diabetes self-care activities during the past seven days using the Summary of Diabetes Self-Care Activities Measure

    Measured: 3 months

  5. Patient engagement with Diabetes Self-Management Training (Aim 3)

    Engagement data will be collected by research staff. It will be measured by the numbers of patients who request contact, are reached, enrolled in the study and scheduled DSMT appointment.

    Measured: 9 months

  6. Hemoglobin A1C (HbA1C) (Aim 3)

    Measurement of HbA1c values to determine impact of intervention. HbA1c values at baseline visit will be compared with values at 3-6 months after participant's enrollment. These data will be obtained through EHR chart review.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start13 Jan 2021
  3. Primary completion1 Nov 2022
  4. Study completion1 Jan 2024

Resources

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
Model description
The purpose of this study is to develop and usability test a patient-centric intervention designed to improve implementation of diabetes self-management training. To accomplish this, 3 specific aims will be completed. Aim 1 - Retrospective data from the UMass Medical School EHR data repository will be analyzed to identify different clusters of patients with diabetes. Aim 2 - To facilitate a patient-centric design of the DM-BOOST intervention, Patient Research Expert Panel (PREP) members (n\</=10) will be recruited from various patient types identified in Aim 1 (Aim 2a), participate in Community Engagement Studios to inform intervention conceptualization (Aim 2b) and usability test the intervention (Aim 2c). Aim 3 - The intervention will be pilot tested in n\</=70 patients with type 2 diabetes (T2D). Participants will be randomized to either intervention or comparison groups.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04710940
Sponsor's protocol ID
H00017902
Acronym
DM-BOOST
Status last verified
Feb 2024
First submitted
29 Dec 2020
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes BOOST in people with Diabetes Mellitus, Type 2, run by Daniel Amante 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 6 inclusion and 5 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 22 Feb 2024. 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?

Intervention Acceptability (Aim 2) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710940.

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 22 Feb 2024.

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DM-BOOST Clinical Trial NCT04710940 | AzTrials