RECRUITING

Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age

Quick Facts

Study Start:2023-03-23
Study Completion:2024-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05416060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hispanic/Latino adults who are registered patients of Scripps Health
  2. * Diagnosis of Type 2 Diabetes
  3. * HbA1c greater than or equal to 8% within the last 60 days
  1. * Severe illness precluding visits to clinic
  2. * Liver function tests (ALT and AST) \> 3 times the upper limit of normal
  3. * Body mass index ≤ 23 kg/cm
  4. * 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
  5. * Creatinine \>3.5
  6. * History of drug or alcohol abuse within 12 months prior to randomization
  7. * Current enrollee in DSME/S
  8. * Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
  9. * Anemia
  10. * Lack of minimal literacy needed to participate in the text intervention
  11. * Severe auditory or visual problems
  12. * Primary language other than Spanish or English
  13. * Not willing to carry a mobile phone
  14. * Pregnant
  15. * Plans to relocate

Contacts and Locations

Study Contact

Athena Philis-Tsimikas, MD
CONTACT
858-678-7046
philis-tsimikas.athena@scrippshealth.org
Monica Ruiz, MA
CONTACT
858-678-7049
ruiz.monica@scrippshealth.org

Principal Investigator

Athena Philis-Tsimikas, MD
PRINCIPAL_INVESTIGATOR
Scripps Health

Study Locations (Sites)

Scripps Chula Vista Diabetes Center
Chula Vista, California, 91910
United States
Scripps Whittier Diabetes Institute
San Diego, California, 92121
United States

Collaborators and Investigators

Sponsor: Scripps Whittier Diabetes Institute

  • Athena Philis-Tsimikas, MD, PRINCIPAL_INVESTIGATOR, Scripps Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-23
Study Completion Date2024-11-30

Study Record Updates

Study Start Date2023-03-23
Study Completion Date2024-11-30

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Health Education
  • mHealth Technology
  • Group Education
  • Telehealth
  • Text-Based

Additional Relevant MeSH Terms

  • Diabetes Type 2