Clinical trial NCT05378620: Project Dulce for Filipino-Americans With Type 2 Diabetes
Official title: Project Dulce for Filipino-Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes
Self-Management
Education
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to culturally adapt an existing American Diabetes Association (ADA)-recognized diabetes self-management and support or DSMES (Diabetes Self Management Education Support) program (Project Dulce) and integrate an evidence-based text messaging program (Dulce Digital) for implementation in Filipino Americans (FAs) with type 2 diabetes mellitus (T2DM). Cultural adaptations aims to facilitate and enhance patient centered approaches and increase participant engagement by addressing barriers to DSMES unique to FAs, such as linguistic challenges, health literacy and numeracy, cultural beliefs and values, and technology access and use. In addition, this study aims to examine the effectiveness of the culturally and digitally adapted Project Dulce + Dulce Digital in improving diabetes knowledge, belief, attitudes, hemoglobin A1C (glycosylated hemoglobin), and self-management behaviors at baseline to 3 months and 6 months. The unprecedented increase of T2DM prevalence among racial and ethnic minority populations including FAs in recent decades demands for effective strategies to meet the needs in DSMES in this population. The outcomes of the current study will demonstrate that the culturally adapted Project Dulce and integration of Dulce Digital is effective in addressing the needs FAs, an underserved racial and ethnic minority group in high need of culturally appropriate DSMES.

Detailed description: Type 2 diabetes mellitus (T2DM) disproportionately affects racial and ethnic minority populations. Among Asian Americans, Filipino Americans (FA) have the second highest T2DM prevalence and have an increased risk for developing complications due to lack of engagement in health protective behaviors (e.g., eating healthfully, obtaining adequate activity) and increased social and environmental barriers to optimal self-management (e.g., access to culturally appropriate education programs). While diabetes self-management education (DSME) programs have been shown to significantly improve T2DM outcomes, fewer than 10% of newly-diagnosed individuals receive DSMES within the first year of diagnosis.

Project Dulce is an American Diabetes Association (ADA)-recognized adult T2DM management program developed to address the needs of a racially and ethnically diverse San Diego population. Project Dulce includes a multi-disciplinary team with peer educators delivering DSMES. Previous trials have shown Project Dulce team-care improves clinical management and reduces costs (e.g., Philis-Tsimikas et al., 2004; Gilmer et al., 2005), and that the peer education alone improves clinical outcomes in Hispanics with T2DM (Philis-Tsimikas et al., 2011). The program has been disseminated locally, nationally, and internationally to White and Hispanic populations and has now served over 20,000 people. More recently, the peer education content was adapted via the Dulce Digital program to extend the reach of the care team through text messages derived from the Project Dulce curriculum, including medication reminders, and blood glucose monitoring prompts. This program led to a significant reduction of hemoglobin AHbA1c across 10 months versus usual care in Hispanics with diabetes (Fortmann et al., 2017). While Project Dulce has been adapted and demonstrated improvements in clinical and cost outcomes in Hispanic patients, cultural and digital adaptations are needed to increase and facilitate use in other racial and ethnic minority groups including FAs.

Using a Community-Based Participatory Research (CBPR) approach, this study will adapt Project Dulce + Dulce Digital for implementation in FA adults with T2DM. Cultural adaptations aims to facilitate and enhance patient-centered approaches by addressing barriers to DSMES unique to this population, such as linguistic challenges, health literacy and numeracy, cultural beliefs and values, and technology access and use. In addition, ADA has recommended the use of digital technologies as effective methods to deliver DSMES and mitigate barriers to participation. The adaptation process will be demonstrated in partnership with a local Federally Qualified Health Center (FQHC) serving a large number of FAs from diverse socioeconomic backgrounds. This study aims to culturally adapt Project Dulce and Dulce Digital for FAs with T2DM. Specifically, this study aims to:

1. examine the effectiveness of the culturally adapted Project Dulce + Dulce Digital in improving diabetes knowledge, attitudes, and beliefs among FAs with T2DM;
2. examine the effectiveness of the culturally adapted Project Dulce + Dulce Digital in improving HbA1C and self-management behaviors (i.e., diet, physical activity, medication adherence, foot care, blood glucose monitoring from baseline to 3- and 6-months; and
3. evaluate the acceptability and feasibility of the culturally adapted Project Dulce + Dulce Digital when delivered by FA peer educator to FA patients with T2DM.

Eligibility criteria: Inclusion Criteria:

* Self-identified Filipino
* Diagnosed with T2DM
* Registered at Scripps Health or San Ysidro Health (or willing to register)
* HbA1c ≥7.5% and/or systolic blood pressure ≥ 140, and/or LDL-C ≥ 100 mg/dL within 90 days
* Able to speak, read, write, and comprehend in English and Tagalog
* Have access to a cell phone that can receive/send text messages throughout the study

Exclusion Criteria:

* Severe illness precluding frequent 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 \>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 enrollment
* Not a permanent resident in the area
* Current enrollee in Project Dulce
* Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
* Anemia
* Type 1 or gestational diabetes
* Pregnant
* Are currently participating in another diabetes-related study

Primary outcomes:
measure: Change from Baseline Diabetes Knowledge at 3 months
timeFrame: 3 months
measure: Change from Baseline Diabetes Knowledge at 6 months
timeFrame: 6 months
measure: Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
timeFrame: 3 months
measure: Change in Baseline Self-Efficacy for Diabetes Scale at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
timeFrame: 3 months
measure: Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
timeFrame: 6 months
measure: Change in Baseline Block Food Frequency Questionnaire at 3 months
timeFrame: 3 months
measure: Change in Baseline Block Food Frequency Questionnaire at 6 months
timeFrame: 6 months
measure: Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
timeFrame: 3 months
measure: Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
timeFrame: 6 months
measure: Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units
timeFrame: 3 months
measure: Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units
timeFrame: 6 months
Other outcomes:
measure: Recruitment and Retention
timeFrame: 6 months
measure: Participant Satisfaction
timeFrame: 6 months
Locations:
city: National City
country: United States
facility: San Ysidro Health
state: California
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Emily Rose N. San Diego, PhD
role: PRINCIPAL_INVESTIGATOR
References: