Back to resultsConexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
Primary Purpose
Diabetes Mellitus, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conexion Localized
Conexion Generic
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Conexion, Diabetes, Depression, Low-income, Hispanic
Eligibility Criteria
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:
-
Sites / Locations
- Isabella Geriatric Center
- YM-YWHA of Washington Heights
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Localized Information Resource Intervention
Generic Information Resource Intervention
Arm Description
Outcomes
Primary Outcome Measures
Patient Activation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03984929
First Posted
June 11, 2019
Last Updated
March 30, 2023
Sponsor
Columbia University
Collaborators
National Library of Medicine (NLM)
1. Study Identification
Unique Protocol Identification Number
NCT03984929
Brief Title
Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
Official Title
Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Library of Medicine (NLM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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".
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Depression
Keywords
Conexion, Diabetes, Depression, Low-income, Hispanic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Localized Information Resource Intervention
Arm Type
Experimental
Arm Title
Generic Information Resource Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Conexion Localized
Intervention Description
The localized version of Conexion is an online health information resource on diabetes and depression tailored for the target community.
Intervention Type
Behavioral
Intervention Name(s)
Conexion Generic
Intervention Description
The generic version of Conexion is an online health information resource on diabetes and depression.
Primary Outcome Measure Information:
Title
Patient Activation
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Kukafka, DrPH, FACMI
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isabella Geriatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10040
Country
United States
Facility Name
YM-YWHA of Washington Heights
City
New York
State/Province
New York
ZIP/Postal Code
10040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
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