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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02969954
Other study ID # 16-005091
Secondary ID
Status Completed
Phase N/A
First received November 16, 2016
Last updated February 12, 2018
Start date November 2016
Est. completion date December 2017

Study information

Verified date February 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Racial and ethnic minorities with type II diabetes in the US are more likely to develop complications and die from the disease than the general population. The foreign-born subset of this population is less likely to adhere to diabetes care recommendations than US-born patients, thereby placing them at higher risk for complications. In our previous pilot project, eight stories were assessed through preliminary multi-site intervention for acceptability and efficacy in diabetes management among Latino and Somali patients with poorly controlled type II diabetes. The goal of this project is to evaluate a new format for delivery of a culturally tailored digital storytelling intervention by incorporating a facilitated group discussion following the videos, for management of type II diabetes in Latino communities.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Self-identify as Hispanic/Latino

2. Are Spanish-speaking

3. Receive primary care at one of the participating clinical sites

4. Self-reported diagnosis of type II diabetes

Exclusion criteria:

1. Not able to give informed consent

2. Not able to participate in a group discussion

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-efficacy for diabetes management
Participants at both sites will watch a 12 minute video featuring the digital stories on diabetes. Following the video, participants will engage in a brief facilitated discussion regarding motivations and barriers to diabetes management, led by a trained Spanish-speaking facilitator.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-efficacy for diabetes management The evaluation will assess the degree to which the intervention motivates the patient to improve self-management of diabetes. The evaluation will also assess overall acceptability. Items for this survey were adapted from a well validated health communication assessment tool produced by the National Cancer Institute. Assessment will be done immediately after participants watch the intervention video
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