NCT04266054

Brief Summary

Somali adults are more likely to have type 2 diabetes mellitus (T2D) and more likely to die from the disease than non-Somali 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-Somali 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 Somali 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 Somali 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 format. The respective digital storytelling videos will be pilot tested with 80 patients in Rochester, MN. In a mirror project for Hispanic adults, 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 Somali adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

February 10, 2020

Last Update Submit

July 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glycemic control as measured by hemoglobin A1c. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion.

    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 Somali populations compared with non-Somali 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.

    6 months

Secondary Outcomes (5)

  • Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).

    6 months

  • Seated blood pressure measurements (systolic and diastolic) will be made on the right arm using an automated blood pressure device after sitting quietly for five minutes.

    6 months

  • Body mass index

    6 months

  • Total cholesterol, HDL cholesterol, will be measured from the same blood sample used to derive the outcome measure. LDL-cholesterol will be calculated for each participant based on these values.

    3 months

  • triglycerides will be measured from the same blood sample used to derive the outcome measure.

    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

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

Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identifies as Somali
  • Between 18 and 70 years of age.
  • Receives primary care at Mayo Clinic ECH.
  • Visited the primary care site at least once in the least twelve months.
  • Intention to continue receiving care at the clinic for the next six months.
  • Diagnosis of T2D in medical record.
  • T2D diagnosis for six months or longer.
  • Most recent hemoglobin A1c≥8%.

You may not qualify if:

  • \. Not eligible if someone in the same household is participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Jane Njeru, MB, ChB

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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

February 10, 2020

First Posted

February 12, 2020

Study Start

December 3, 2019

Primary Completion

May 8, 2022

Study Completion

June 30, 2024

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations