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Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults

Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03766438
Acronym
S4C
Enrollment
451
Registered
2018-12-06
Start date
2019-02-14
Completion date
2024-09-30
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

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

Hennepin Healthcare
CollaboratorOTHER
Mountain Park Health Center - Phoenix, AZ
CollaboratorUNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 MonthsBaseline 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

ArmCount
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
Total451

Baseline characteristics

CharacteristicControlTotalIntervention
Age, Continuous54.5 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 Participants451 Participants227 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hemoglobin A1C9.4 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 participants451 participants227 participants
Sex: Female, Male
Female
156 Participants314 Participants158 Participants
Sex: Female, Male
Male
68 Participants137 Participants69 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2270 / 224
other
Total, other adverse events
0 / 2270 / 224
serious
Total, serious adverse events
0 / 2270 / 224

Outcome results

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.

Time frame: Baseline and 3 months.

ArmMeasureGroupValue (MEAN)Dispersion
InterventionGlycemic Control as Measured by Hemoglobin A1c at Baseline and 3 MonthsBaseline9.1 PercentStandard Deviation 1.7
InterventionGlycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months3 months8.4 PercentStandard Deviation 1.6
ControlGlycemic Control as Measured by Hemoglobin A1c at Baseline and 3 MonthsBaseline9.4 PercentStandard Deviation 1.8
ControlGlycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months3 months8.8 PercentStandard Deviation 2

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026