Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05378620
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2022-05-10
Brief Title:
Project Dulce for Filipino-Americans With Type 2 Diabetes
Sponsor:
Scripps Whittier Diabetes Institute
Organization:
Scripps Whittier Diabetes Institute
Study Overview
Official Title:
Project Dulce for Filipino-Americans With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg eating healthfully obtaining adequate activity and increased social and environmental barriers to optimal self-management eg 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 eg 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 20000 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 ie 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
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 eg 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 20000 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KL2TR002552 | NIH | None | httpsreporternihgovquickSearchKL2TR002552 |