MedDataX Logo

Trial Outcomes & Findings for Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults (NCT NCT03766438)

NCT ID: NCT03766438

Last Updated: 2024-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

451 participants

Primary outcome timeframe

Baseline and 3 months.

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention
The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Digital Storytelling Intervention: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
Control
The comparison group will receive usual clinical care.
Overall Study
STARTED
227
224
Overall Study
COMPLETED
191
199
Overall Study
NOT COMPLETED
36
25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=227 Participants
The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Digital Storytelling Intervention: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
Control
n=224 Participants
The comparison group will receive usual clinical care.
Total
n=451 Participants
Total of all reporting groups
Age, Continuous
54.3 years
STANDARD_DEVIATION 9.25 • n=5 Participants
54.5 years
STANDARD_DEVIATION 9.08 • n=7 Participants
54.4 years
STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male
Female
158 Participants
n=5 Participants
156 Participants
n=7 Participants
314 Participants
n=5 Participants
Sex: Female, Male
Male
69 Participants
n=5 Participants
68 Participants
n=7 Participants
137 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
227 Participants
n=5 Participants
224 Participants
n=7 Participants
451 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
227 participants
n=5 Participants
224 participants
n=7 Participants
451 participants
n=5 Participants
Hemoglobin A1C
9.1 Percent
STANDARD_DEVIATION 1.72 • n=5 Participants
9.4 Percent
STANDARD_DEVIATION 1.75 • n=7 Participants
9.25 Percent
STANDARD_DEVIATION 1.73 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention
n=191 Participants
The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care. Digital Storytelling Intervention: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
Control
n=199 Participants
The comparison group will receive usual clinical care.
Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months
3 months
8.4 Percent
Standard Deviation 1.6
8.8 Percent
Standard Deviation 2
Glycemic Control as Measured by Hemoglobin A1c at Baseline and 3 Months
Baseline
9.1 Percent
Standard Deviation 1.7
9.4 Percent
Standard Deviation 1.8

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Wieland, MD, MPH

Mayo Clnic

Phone: 507-284-1195

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place