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

NCT03766438 | Completed Results DMC

• 2 other identifiers: 18-002998R01DK113999-01A1
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 3

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Behavioral: Digital Storytelling Intervention

Control

NO INTERVENTION

The comparison group will receive usual clinical care.

Interventions

Digital Storytelling Intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• Hennepin Healthcare: collaborator
• Mountain Park Health Center - Phoenix, AZ: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Mountain Park Health Center

Phoenix, Arizona, 85012, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 39093566 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.

  PMID: 36682492 DERIVED

Results Point of Contact

• Title: Mark Wieland, MD, MPH
• Organization: Mayo Clnic

wieland.mark@mayo.edu

507-284-1195

Study Officials

• Mark L Wieland

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 6, 2018
• Study Start: February 14, 2019
• Primary Completion: November 1, 2023
• Study Completion: September 30, 2024
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Locations

US (3)