Diabetes MellitusNCT03984929
Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
A study testing Conexion Localized and Conexion Generic in people with Diabetes Mellitus and Depression, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Depression
- What is being tested?
- Conexion Localized and Conexion Generic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2019to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Isabella Geriatric Center
New York, New York, 10040
YM-YWHA of Washington Heights
New York, New York, 10040
About this study
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".
Read the 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.
- Conditions
- Diabetes Mellitus, Depression
- Being tested
- Conexion Localized, Conexion Generic
- Keywords
- Conexion, Diabetes, Depression, Low-income, Hispanic
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conexion LocalizedBehavioural
The localized version of Conexion is an online health information resource on diabetes and depression tailored for the target community.
Conexion GenericBehavioural
The generic version of Conexion is an online health information resource on diabetes and depression.
| Study group | Role | What they receive |
|---|---|---|
| Localized Information Resource Intervention | Experimental | Not described Receives: Behavioral: Conexion Localized |
| Generic Information Resource Intervention | Active comparator | Not described Receives: Behavioral: Conexion Generic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Jun 2019
- Primary completion15 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Rita Kukafka, Columbia University
- Investigators
- Rita Kukafka, DrPH, FACMI, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984929
- Sponsor's protocol ID
- AAAR5605
- Other IDs
- G08LM012689
- Status last verified
- Mar 2023
- First submitted
- 11 Jun 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conexion: A Localized Information Resource on Diabetes and Depression for a Low-income Hispanic Community
- ClinicalTrials.gov ID
- NCT03984929
- Acronym / sponsor ID
- AAAR5605
- Conditions
- Diabetes Mellitus, Depression
- Keywords
- Conexion, Diabetes, Depression, Low-income, Hispanic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Localized Information Resource Intervention | Experimental | Behavioral: Conexion Localized |
| Generic Information Resource Intervention | Active comparator | Behavioral: Conexion Generic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conexion LocalizedThe localized version of Conexion is an online health information resource on diabetes and depression tailored for the target community. | Behavioural | Localized Information Resource Intervention |
| Conexion GenericThe generic version of Conexion is an online health information resource on diabetes and depression. | Behavioural | Generic Information Resource Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Kukafka, DrPH, FACMI principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conexion Localized and Conexion Generic in people with Diabetes Mellitus and Depression, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.