NCT03984929

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

3.1 years

First QC Date

June 11, 2019

Last Update Submit

March 30, 2023

Conditions

Keywords

ConexionDiabetesDepressionLow-incomeHispanic

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (2)

Localized Information Resource Intervention

EXPERIMENTAL
Behavioral: Conexion Localized

Generic Information Resource Intervention

ACTIVE COMPARATOR
Behavioral: Conexion Generic

Interventions

The localized version of Conexion is an online health information resource on diabetes and depression tailored for the target community.

Localized Information Resource Intervention

The generic version of Conexion is an online health information resource on diabetes and depression.

Generic Information Resource Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Isabella Geriatric Center

New York, New York, 10040, United States

Location

YM-YWHA of Washington Heights

New York, New York, 10040, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDepression

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Rita Kukafka, DrPH, FACMI

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biomedical Informatics and Sociomedical Sciences

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 13, 2019

Study Start

June 1, 2019

Primary Completion

July 15, 2022

Study Completion

August 15, 2022

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations