- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03121508
Taking on Diabetes to Advance You (TODAY) (TODAY)
July 10, 2018 updated by: Arlene Schmid
Taking on Diabetes to Advance You
The program will consist of diabetes self-management sessions, led by an occupational therapist.
The sessions will be held in an individualized format.
Sessions will focus on diabetes education, self-management education, and education on behaviors and adaptive techniques to optimize participation in daily life with type II diabetes.
As occupational therapists, the investigators and facilitator, aim to focus on establishing healthy habits, roles, and routines for individuals with type 2 diabetes.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
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
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Colorado
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Fort Collins, Colorado, United States, 80524
- Family medicine center
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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:
- type 2 diabetes
- 18 or older
- patient at the Family Medicine Center in Fort Collins
Exclusion Criteria:
- reading level below 6th grade
- inability to understand written or verbal instructions regarding questionnaires
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: TODAY Project
All participants will attend individualized self-management sessions led by an occupational therapist.
The classes will focus on promoting modifying daily activities, habits, roles, and routines to promote healthy lifestyles for individuals with type 2 diabetes.
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This is an individualized educational intervention with activity components designed to assist in modifying habits, roles, and routines to promote healthy lifestyle patterns for individuals with type 2 diabetes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Diabetes Self-Management Questionnaire
Time Frame: through the end of the intervention period, up to one year
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16-item self-report to assess self-care activities associated with diabetes
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through the end of the intervention period, up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matt Malcolm, PhD, Colorado State University
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)
April 24, 2017
Primary Completion (Actual)
April 24, 2018
Study Completion (Anticipated)
June 24, 2018
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
April 17, 2017
First Posted (Actual)
April 20, 2017
Study Record Updates
Last Update Posted (Actual)
July 12, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-6245H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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