Clinical trial NCT05416060: Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
Official title: Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes
Health Education
mHealth Technology
Group Education
Telehealth
Text-Based
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a three-arm, non-blinded, randomized, controlled, parallel-groups, comparative effectiveness trial with N=150 participants.

The protocol was developed in accordance with Good Clinical Practice, SPIRIT, and CONSORT 2013 guidelines.
Primary purpose: PREVENTION

Brief summary: The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.

Detailed description: Diabetes self-management education using digital platforms including, telehealth group visits, text-based messages and live delivery will result in improvements in diabetes health behaviors, patient engagement, health literacy and HbA1c.

Diabetes disproportionately affects racial and ethnic communities. The investigator developed Project Dulce, an American Diabetes Association-recognized and Medicare-approved Diabetes Self-Management Education and Support (DSME/S) program addresses the needs of a racially and ethnically diverse San Diego population and includes a multi-disciplinary team with peer educators delivering DSME/S. Previous trials have shown Project Dulce team-care improves clinical management and reduces costs and that the peer education alone improves clinical outcomes in Hispanics with Type 2 Diabetes across 10 months.

Mobile health (mHealth) technologies represent a viable way to overcome many of these barriers and extend the reach of DSME/S to participants who need it most.

During the coronavirus disease (COVID-19) pandemic, Project Dulce was adapted for group telehealth settings and delivered via the electronic medical record (EMR) scheduling system. Additionally, a previously developed text messaging platform-Dulce Digital was offered to extend the reach of the care team through educational and motivational messaging, medication reminders, and blood glucose monitoring prompts. A previous randomized controlled trial of Dulce Digital demonstrated a significant reduction of HbA1c across 10 months versus usual care in Hispanics with diabetes. While live Project Dulce and Dulce Digital programs have demonstrated improvements in clinical and cost outcomes in Hispanic patients, a comparative analysis of live, group telehealth and text messaging programs has not been done. This study will assess a direct comparison of each of these modalities to explore the feasibility, acceptance, and effectiveness of each delivery modality across Hispanic communities living with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Hispanic/Latino adults who are registered patients of Scripps Health
* Diagnosis of Type 2 Diabetes
* HbA1c greater than or equal to 8% within the last 60 days

Exclusion Criteria:

* Severe illness precluding visits to clinic
* Liver function tests (ALT and AST) \> 3 times the upper limit of normal
* Body mass index ≤ 23 kg/cm
* History of malignancy, except subjects who have been disease-free for \>2 years, or whose only malignancy has been basal or squamous cell skin carcinoma
* Creatinine \>3.5
* History of drug or alcohol abuse within 12 months prior to randomization
* Current enrollee in DSME/S
* Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
* Anemia
* Lack of minimal literacy needed to participate in the text intervention
* Severe auditory or visual problems
* Primary language other than Spanish or English
* Not willing to carry a mobile phone
* Pregnant
* Plans to relocate

Primary outcomes:
measure: Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
timeFrame: 3 months
measure: Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline Diabetes Distress (DDS-17) at 3 months
timeFrame: 3 months
measure: Change from Baseline Diabetes Distress (DDS-17) at 6 months
timeFrame: 6 months
measure: Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months
timeFrame: 3 months
measure: Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Scripps Chula Vista Diabetes Center
state: California
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Health
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References: