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Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults (S4C)

Primary Purpose

Type2 Diabetes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Storytelling Intervention
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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.

Sites / Locations

  • Mountain Park Health Center
  • Hennepin Healthcare
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

The comparison group will receive usual clinical care.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).
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. In a 2009 review of psychometric tools to assess diabetes self-management behaviors, the SDSCA was one of only three instruments to meet all appraisal criteria113. The SDSCA is also the most commonly used instrument for these domains worldwide, with good validity evidence in several languages, including Spanish114,115. Furthermore, we used this instrument with Hispanic/Latino patients during the early phase (Step 1) for this project22. The SDSCA will be administered by the same language-congruent study staff at each measure.
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.
Blood pressure will be measured three times; the average of the second and third readings will be used in statistical analyses.
Body mass index
Weight will be measured to the nearest 0.1 kg using a clinical scale. Height will be measured in cm with a stadiometer. BMI is calculated as weight (kg)/height squared (m2).
Total cholesterol, HDL cholesterol, and triglycerides 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.
Baseline LDL-cholesterol values will be drawn at the baseline study visit. Cholesterol values at 3 months will be drawn at the 3 month study visit. Subsequent cholesterol levels will not be drawn or abstracted.

Full Information

First Posted
November 27, 2018
Last Updated
April 11, 2023
Sponsor
Mayo Clinic
Collaborators
Hennepin Healthcare, Minneapolis, MN, Mountain Park Health Center - Phoenix, AZ, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03766438
Brief Title
Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
Acronym
S4C
Official Title
Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
March 25, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Hennepin Healthcare, Minneapolis, MN, Mountain Park Health Center - Phoenix, AZ, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The comparison group will receive usual clinical care.
Intervention Type
Behavioral
Intervention Name(s)
Digital Storytelling Intervention
Intervention Description
12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
Primary Outcome Measure Information:
Title
Glycemic control as measured by hemoglobin A1c. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion.
Description
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
6 months.
Secondary Outcome Measure Information:
Title
Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).
Description
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. In a 2009 review of psychometric tools to assess diabetes self-management behaviors, the SDSCA was one of only three instruments to meet all appraisal criteria113. The SDSCA is also the most commonly used instrument for these domains worldwide, with good validity evidence in several languages, including Spanish114,115. Furthermore, we used this instrument with Hispanic/Latino patients during the early phase (Step 1) for this project22. The SDSCA will be administered by the same language-congruent study staff at each measure.
Time Frame
6 months.
Title
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.
Description
Blood pressure will be measured three times; the average of the second and third readings will be used in statistical analyses.
Time Frame
6 months
Title
Body mass index
Description
Weight will be measured to the nearest 0.1 kg using a clinical scale. Height will be measured in cm with a stadiometer. BMI is calculated as weight (kg)/height squared (m2).
Time Frame
6 months
Title
Total cholesterol, HDL cholesterol, and triglycerides 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.
Description
Baseline LDL-cholesterol values will be drawn at the baseline study visit. Cholesterol values at 3 months will be drawn at the 3 month study visit. Subsequent cholesterol levels will not be drawn or abstracted.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Self-identifies as Hispanic or Latino. Between 18 and 70 years of age. Receives primary care at the clinical site. 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%. Not eligible if someone in the same household is participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark L Wieland
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain Park Health Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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