Clinical trial NCT03766438: Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
Official title: Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Hennepin Healthcare
name: Mountain Park Health Center - Phoenix, AZ
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-12-06
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months
timeFrame: Baseline and 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mountain Park Health Center
state: Arizona
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark L Wieland
role: PRINCIPAL_INVESTIGATOR
References: