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

NCT ID: NCT03766438

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care.

Group Type EXPERIMENTAL

Digital Storytelling Intervention

Intervention Type BEHAVIORAL

12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.

Control

The comparison group will receive usual clinical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Storytelling Intervention

12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hennepin Healthcare

OTHER

Sponsor Role collaborator

Mountain Park Health Center - Phoenix, AZ

UNKNOWN

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark L Wieland

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark L Wieland

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mountain Park Health Center

Phoenix, Arizona, United States

Site Status

Hennepin Healthcare

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39093566 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36682492 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01DK113999-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-002998

Identifier Type: -

Identifier Source: org_study_id

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