- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969954
Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Diabetes
February 12, 2018 updated by: Jane W. Njeru, M.B., Ch.B., Mayo Clinic
Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Reduction of Diabetes-Related Health Disparities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Self-identify as Hispanic/Latino
- Are Spanish-speaking
- Receive primary care at one of the participating clinical sites
- Self-reported diagnosis of type II diabetes
Exclusion criteria:
- Not able to give informed consent
- Not able to participate in a group discussion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
Study has one arm - who will all receive the intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy for diabetes management
Time Frame: Assessment will be done immediately after participants watch the intervention video
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jane W Njeru, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
November 16, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimate)
November 21, 2016
Study Record Updates
Last Update Posted (Actual)
February 14, 2018
Last Update Submitted That Met QC Criteria
February 12, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-005091
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.
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