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

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ClinicalTrials.gov Identifier: NCT03766438
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Hennepin Healthcare, Minneapolis, MN
Mountain Park Health Center - Phoenix, AZ
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mark L Wieland, Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: Digital Storytelling Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.

No Intervention: Control
The comparison group will receive usual clinical care.



Primary Outcome Measures :
  1. Glycemic control as measured by hemoglobin A1c. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion. [ Time Frame: 6 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.


Secondary Outcome Measures :
  1. Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA). [ Time Frame: 6 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. 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.

  2. 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. [ Time Frame: 6 months ]
    Blood pressure will be measured three times; the average of the second and third readings will be used in statistical analyses.

  3. Body mass index [ Time Frame: 6 months ]
    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).

  4. 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. [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766438


Locations
United States, Arizona
Mountain Park Health Center Not yet recruiting
Phoenix, Arizona, United States, 85012
Contact: Valentina Hernandez    602-323-3158    vhernandez@mphc-az.org   
Principal Investigator: Davinder Singh, MD         
United States, Minnesota
Hennepin Healthcare Not yet recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Latasha Jennings, MPH    612-873-3034    Latasha.Jennings@hcmed.org   
Principal Investigator: Katherine Vickery, md         
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Hennepin Healthcare, Minneapolis, MN
Mountain Park Health Center - Phoenix, AZ
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mark L Wieland Mayo Clinic

Responsible Party: Mark L Wieland, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03766438     History of Changes
Other Study ID Numbers: 18-002998
R01DK113999-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases