- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738032
Stories for Change: Digital Storytelling Intervention for Diabetes Self-Management in the COVID-19 Pandemic (S4C - COVID-19)
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 during a pandemic.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85012
- Mountain Park Health Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Hennepin Healthcare
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Self-identifies as Hispanic or Latino.
- Between 18 and 70 years of age.
- Participated in the parent study
Exclusion Criteria:
- Does not self-identifies as Hispanic or Latino.
- Is not between 18 and 70 years of age.
- Did not participated in the parent study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes self-management behaviors
Time Frame: 5 months
|
This is a brief survey instrument to assess the following domains: general diet, specific (diabetes) diet, physical activity, diabetes medication use, and blood glucose monitoring during the pandemic.
|
5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Endocrine System Diseases
- COVID-19
- Diabetes Mellitus
Other Study ID Numbers
- 20-006354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type2 Diabetes
-
Mathias Ried-LarsenUnknownDiabetes Mellitus, Type 2 | Type 2 Diabetes Mellitus | Type2 Diabetes | Type2 Diabetes MellitusDenmark
-
Johns Hopkins UniversityBeth Israel Deaconess Medical CenterActive, not recruitingHypertension | Diabetes Mellitus, Type 2 | Diabetes | Diabetes type2 | Type 2 Diabetes | Type2 Diabetes | Type II Diabetes | High Blood PressureUnited States
-
Sigrid Therapeutics ABCompletedOverweight | PreDiabetes | Prediabetic State | Type2 Diabetes | Obese | Type2 Diabetes Mellitus | Pre DiabetesFinland, Sweden
-
University of ChicagoCompleted
-
Michigan State UniversityUniversity of Michigan; Claremont Graduate UniversityUnknown
-
University of AlbertaSherwood Park Strathcona County Primary Care Network, AlbertaCompleted
-
Region SkaneGöteborg UniversityActive, not recruitingType2 DiabetesSweden
-
University of Missouri-ColumbiaCompleted
-
University Hospital, Gentofte, CopenhagenCompletedType2 DiabetesDenmark
Clinical Trials on Digital Storytelling Intervention
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Hennepin... and other collaboratorsCompletedType2 DiabetesUnited States
-
Arizona State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruitingHealth Knowledge, Attitudes, Practice | COVID-19 Pandemic | Vaccine-Preventable Diseases | Health-Related Behavior | NarrationUnited States
-
Mayo ClinicActive, not recruitingType2 DiabetesUnited States
-
Arizona State UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedHealth Knowledge, Attitudes, Practice | Human Papilloma Virus | Preventable Disease, Vaccine | NarrativeUnited States
-
Arizona State UniversityNational Cancer Institute (NCI); Mayo ClinicCompletedDepression | Stress | Anxiety | Hematopoietic Stem Cell Transplantation | Bone Marrow Transplant | Information Disclosure | Psychosocial Health | NarrativeUnited States
-
Vanderbilt UniversityRita & Alex Hillman FoundationCompleted
-
Denver Health and Hospital AuthorityNot yet recruiting
-
Arizona State UniversityHonorHealth Research InstituteCompletedStress | Psychological Distress | Hematopoietic Stem Cell Transplantation | Mood | Emotion Regulation | Heart Rate Variability | Communication Research | Bone Marrow Transplant | Autonomic Nervous System | NarrativeUnited States