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Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984929
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Rita Kukafka, Columbia University

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".

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Depression Behavioral: Conexion Localized Behavioral: Conexion Generic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Localized Information Resource Intervention Behavioral: Conexion Localized
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 Behavioral: Conexion Generic
The generic version of Conexion is an online health information resource on diabetes and depression.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984929


Contacts
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Contact: Rita Kukafka, DrPH, FACMI 212-305-9193 rk326@cumc.columbia.edu

Locations
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United States, New York
Isabella Geriatric Center Not yet recruiting
New York, New York, United States, 10040
Contact: Rita Kukafka, DrPH, FACMI    212-305-9193    rk326@cumc.columbia.edu   
YM-YWHA of Washington Heights Not yet recruiting
New York, New York, United States, 10040
Contact: Rita Kukafka, DrPH, FACMI    212-305-9193    rk326@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Library of Medicine (NLM)
Investigators
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Principal Investigator: Rita Kukafka, DrPH, FACMI Columbia University

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Responsible Party: Rita Kukafka, Professor of Biomedical Informatics and Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT03984929     History of Changes
Other Study ID Numbers: AAAR5605
G08LM012689 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rita Kukafka, Columbia University:
Conexion
Diabetes
Depression
Low-income
Hispanic
Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders