Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK113999-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hennepin Healthcare | OTHER |
| Mountain Park Health Center - Phoenix, AZ | UNKNOWN |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that arise from affected communities are needed to address these health disparities.
Community-based participatory research (CBPR) has been successful in targeting health issues among Hispanic and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP)
Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs.
RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video forma. The respective digital storytelling videos were pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change.
The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Hispanic adults.
The study team will conduct a two-group randomized controlled trial in primary care clinical settings at two healthcare institutions among 450 Hispanic adults with poorly controlled T2D (hemoglobin A1c≥8%). The intervention group will view the 12-minute digital storytelling video. Both the intervention and comparison groups will receive diabetes education and resource cards, as well as usual clinical care. The primary outcome will be glycemic control as measured by hemoglobin A1c 3 months after intervention delivery. Secondary outcomes will include diabetes self-management behaviors, blood pressure, LDL-cholesterol, and body mass index. The impact of concomitant covariates, including sex, age, and socio-economic status, on the sensitivity of the intervention effect will also be explored.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. |
|
| Control | No Intervention | The comparison group will receive usual clinical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Storytelling Intervention | Behavioral | 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on national and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic populations compared with non-Hispanic whites. The importance of glycemic control as part of the comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established strategy to monitor glycemic control in patients with diabetes. | Baseline and 3 months. |
Not provided
Not provided
Not eligible if someone in the same household is participating in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark L Wieland | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain Park Health Center | Phoenix | Arizona | 85012 | United States | ||
| Hennepin Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39093566 | Derived | Wieland ML, Vickery KD, Hernandez V, Ford BR, Gonzalez C, Kavistan S, Iteghete S, Patten CA, Njeru JW, Lohr AM, O'Byrne J, Novotny PJ, Singh DP, Larkey LK, Goodson M, Capetillo GP, Sia IG. Digital Storytelling Intervention for Hemoglobin A1c Control Among Hispanic Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2424781. doi: 10.1001/jamanetworkopen.2024.24781. | |
| 36682492 | Derived | Lohr AM, Vickery KD, Hernandez V, Ford BR, Gonzalez C, Kavistan S, Patten CA, Njeru JW, Novotny PJ, Larkey LK, Singh D, Wieland ML, Sia IG. Stories for change protocol: A randomized controlled trial of a digital storytelling intervention for Hispanic/Latino individuals with type 2 diabetes. Contemp Clin Trials. 2023 Mar;126:107093. doi: 10.1016/j.cct.2023.107093. Epub 2023 Jan 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Digital Storytelling Intervention: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories. |
| FG001 | Control | The comparison group will receive usual clinical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Digital Storytelling Intervention: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on national and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic populations compared with non-Hispanic whites. The importance of glycemic control as part of the comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established strategy to monitor glycemic control in patients with diabetes. | Posted | Mean | Standard Deviation | Percent | Baseline and 3 months. |
|
Through study completion (6 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Digital Storytelling Intervention: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Wieland, MD, MPH | Mayo Clnic | 507-284-1195 | wieland.mark@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2024 | Sep 27, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| BG001 |
| Control |
The comparison group will receive usual clinical care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1C | Mean | Standard Deviation | Percent |
|
| OG001 | Control | The comparison group will receive usual clinical care. |
|
|
| 0 |
| 227 |
| 0 |
| 227 |
| 0 |
| 227 |
| EG001 | Control | The comparison group will receive usual clinical care. | 0 | 224 | 0 | 224 | 0 | 224 |
Not provided
Not provided