Type2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Self-identifies as Hispanic or Latino. 2. Between 18 and 70 years of age. 3. Receives primary care at the clinical site. 4. Visited the primary care site at least once in the least twelve months. 5. Intention to continue receiving care at the clinic for the next six months. 6. Diagnosis of T2D in medical record. 7. T2D diagnosis for six months or longer. 8. Most recent hemoglobin A1c≥8%. Not eligible if someone in the same household is participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 227 |
| Control The comparison group will receive usual clinical care. | 224 |
| Total | 451 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 9.08 | 54.4 years STANDARD_DEVIATION 9.15 | 54.3 years STANDARD_DEVIATION 9.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 224 Participants | 451 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1C | 9.4 Percent STANDARD_DEVIATION 1.75 | 9.25 Percent STANDARD_DEVIATION 1.73 | 9.1 Percent STANDARD_DEVIATION 1.72 |
| Region of Enrollment United States | 224 participants | 451 participants | 227 participants |
| Sex: Female, Male Female | 156 Participants | 314 Participants | 158 Participants |
| Sex: Female, Male Male | 68 Participants | 137 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 227 | 0 / 224 |
| other Total, other adverse events | 0 / 227 | 0 / 224 |
| serious Total, serious adverse events | 0 / 227 | 0 / 224 |
Outcome results
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.
Time frame: Baseline and 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | Baseline | 9.1 Percent | Standard Deviation 1.7 |
| Intervention | Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | 3 months | 8.4 Percent | Standard Deviation 1.6 |
| Control | Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | Baseline | 9.4 Percent | Standard Deviation 1.8 |
| Control | Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months | 3 months | 8.8 Percent | Standard Deviation 2 |