- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984929
Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
March 30, 2023 updated by: Rita Kukafka, Columbia University
The proposed Conexion resource combines best publicly available evidence-based information and local community resources in one place.
The information is curated and contextualized to meet local needs of consumers and providers.
Content is tailored culturally and geographically to fit the community.
This approach is consistent with evidence showing that individuals' interactions with health information and technology are "community embedded".
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Nationwide, Hispanics have many barriers to accessing health information, and are subject to significant health disparities, including disproportionate burden of diabetes and untreated mental illness.
The research team's preliminary research has identified diabetes and depression as the highest priority needs in the study community of Washington Heights-Inwood (WAHI), which is an urban, low-income neighborhood in New York City with 71% Hispanic residents, predominantly immigrants from the Dominican Republic.
Many high-quality health information resources already exist on the internet but they are not reaching many segments of the population, including parts of the WAHI community.
The novel concept the investigators propose here is an information resource localized to a community.
Study Type
Interventional
Enrollment (Actual)
136
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
-
-
New York
-
New York, New York, United States, 10040
- Isabella Geriatric Center
-
New York, New York, United States, 10040
- YM-YWHA of Washington Heights
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or older
- Washington Heights/Inwood resident (zip codes 10032, 10033, 10034, 10040)
- interest in information on diabetes or depression
- speak English or Spanish
Exclusion Criteria:
-
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Localized Information Resource Intervention
|
The localized version of Conexion is an online health information resource on diabetes and depression tailored for the target community.
|
|
Active Comparator: Generic Information Resource Intervention
|
The generic version of Conexion is an online health information resource on diabetes and depression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Activation
Time Frame: 1 month
|
Person's active engagement in management of their own health will be measured as a patient activation measure (PAM) score.
The PAM is a validated scale with 13 questions.
The score ranges from 0 to 100, with a higher score indicating a better outcome.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
June 1, 2019
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
June 11, 2019
First Submitted That Met QC Criteria
June 11, 2019
First Posted (Actual)
June 13, 2019
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR5605
- G08LM012689 (U.S. NIH Grant/Contract)
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.