- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06577506
Diabetes Education and Care for Deaf Populations
April 7, 2025 updated by: Michelle Litchman, University of Utah
Improving Access to Diabetes Education and Care for Deaf Populations
This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
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
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- University of Utah
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Identify as Deaf/Hard of Hearing
- living with diabetes (any type)
- speak and understand English or American Sign Language
- have access to internet
- willing to participate in the intervention
Exclusion Criteria:
- participating in another diabetes study
- have significant cognitive impairment
- are pregnant or planning to become pregnant in the next year
- have life expectancy of <6 months
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Deaf Diabetes Can Together
|
10-week diabetes self-management telehealth intervention for deaf adults with diabetes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A1C Level
Time Frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
|
Clinical outcome
|
6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Distress Level Using the Screening Scale Questionnaire
Time Frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
|
Psychosocial outcome, scoring averaged from 1-6 with higher score means worse outcome.
|
6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
|
|
Diabetes Self-Care Level using the Self-Care Inventory Revised Questionnaire
Time Frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
|
Self-management outcome, scoring averaged from 0-100 point scale with higher score means better outcome.
|
6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
August 17, 2023
Primary Completion (Actual)
July 22, 2024
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
November 7, 2023
First Submitted That Met QC Criteria
August 26, 2024
First Posted (Actual)
August 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00151575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.