DiabetesCONNECTNCT02222909
Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes
A study testing Co-developed IT intervention in people with Diabetes and Cardiovascular Disease, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Cardiovascular Disease, Substance Abuse Disorder
- What is being tested?
- Co-developed IT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,767 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Community Based Organization; 501-C3 status; Located within zip codes surrounding Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center; Provides direct services to clients
Who cannot join
- Part of Johns Hopkins Medicine or Baltimore City Agency
Trial locations and contacts
1 site in 1 country.
United States1 site
Zip codes surrounding Johns Hopkins Hospital
Baltimore, Maryland, 21205
About this study
Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process. The remaining 11 are a part of the control intervention group. The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.
Read the detailed description
see above
- Being tested
- Co-developed IT intervention
- Keywords
- Community Based Organization, Reverse Innovation, Social Services, Referral, Chronic disease
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Substance-Related Disorders, Mental Disorders, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-developed IT interventionOther
Also called Healthify
The IT-based intervention is being co-developed with the community based organizations in the intervention group, and comprises tools to improve referral and tracking of clients, use of volunteers, and direct communication with hospital staff members
| Study group | Role | What they receive |
|---|---|---|
| Intervention CBOs | Experimental | Will receive "co-developed IT intervention" developed together with intervention group community based members. Set of primarily web based tools to improve connection with clients, Johns Hopkins Medicine and one another, referrals, and volunteer services. Receives: Other: Co-developed IT intervention |
| Control CBOs | No intervention | Community Based Organizations that are being followed for data collection only for the period of one year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emergency Department Visits + Hospital Days
The change in the average number of monthly emergency department visits and days spent in the hospital from the pre- intervention to the post-intervention period for J-CHiP patients assigned to each of the CBOs, adjusted for baseline prognostic variables.
Measured: Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Albert W Wu, MD MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222909
- Sponsor's protocol ID
- CD-12-11-4948
- Acronym
- CONNECT
- Status last verified
- Jun 2023
- First submitted
- 18 Aug 2014
- Last updated
- 9 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD with other researchers.
Publications
Lowe D, Ryan R, Schonfeld L, Merner B, Walsh L, Graham-Wisener L, Hill S. Effects of consumers and health providers working in partnership on health services planning, delivery and evaluation. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013373. doi: 10.1002/14651858.CD013373.pub2.
PubMed 34523117Wu AW, Weston CM, Ibe CA, Ruberman CF, Bone L, Boonyasai RT, Hwang S, Gentry J, Purnell L, Lu Y, Liang S, Rosenblum M. The Baltimore Community-Based Organizations Neighborhood Network: Enhancing Capacity Together (CONNECT) Cluster RCT. Am J Prev Med. 2019 Aug;57(2):e31-e41. doi: 10.1016/j.amepre.2019.03.013. Epub 2019 Jun 25.
PubMed 31248746Ibe CA, Basu L, Gooden R, Syed SB, Dadwal V, Bone LR, Ephraim PL, Weston CM, Wu AW; Baltimore CONNECT Project Team. From Kisiizi to Baltimore: cultivating knowledge brokers to support global innovation for community engagement in healthcare. Global Health. 2018 Feb 9;14(1):19. doi: 10.1186/s12992-018-0339-8.
PubMed 29426345
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes
- ClinicalTrials.gov ID
- NCT02222909
- Acronym / sponsor ID
- CONNECT / CD-12-11-4948
- Keywords
- Community Based Organization, Reverse Innovation, Social Services, Referral, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,767 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process. The remaining 11 are a part of the control intervention group. The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.
Detailed description
see above
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention CBOs | Experimental | Other: Co-developed IT interventionWill receive "co-developed IT intervention" developed together with intervention group community based members. Set of primarily web based tools to improve connection with clients, Johns Hopkins Medicine and one another, referrals, and volunteer services. |
| Control CBOs | No intervention | –Community Based Organizations that are being followed for data collection only for the period of one year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Community Based Organization; 501-C3 status; Located within zip codes surrounding Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center; Provides direct services to clients
Key exclusion criteria (1 listed)
- Part of Johns Hopkins Medicine or Baltimore City Agency
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 |
|---|---|---|
| Co-developed IT interventionAlso: HealthifyThe IT-based intervention is being co-developed with the community based organizations in the intervention group, and comprises tools to improve referral and tracking of clients, use of volunteers, and direct communication with hospital staff members | Other | Intervention CBOs |
Primary outcome
Change in Emergency Department Visits + Hospital Days
Time frame: Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015
The change in the average number of monthly emergency department visits and days spent in the hospital from the pre- intervention to the post-intervention period for J-CHiP patients assigned to each of the CBOs, adjusted for baseline prognostic variables.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34523117Lowe D, Ryan R, Schonfeld L, Merner B, Walsh L, Graham-Wisener L, Hill S. Effects of consumers and health providers working in partnership on health services planning, delivery and evaluation. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013373. doi: 10.1002/14651858.CD013373.pub2.
- Derived from this study: PubMed 31248746Wu AW, Weston CM, Ibe CA, Ruberman CF, Bone L, Boonyasai RT, Hwang S, Gentry J, Purnell L, Lu Y, Liang S, Rosenblum M. The Baltimore Community-Based Organizations Neighborhood Network: Enhancing Capacity Together (CONNECT) Cluster RCT. Am J Prev Med. 2019 Aug;57(2):e31-e41. doi: 10.1016/j.amepre.2019.03.013. Epub 2019 Jun 25.
- Derived from this study: PubMed 29426345Ibe CA, Basu L, Gooden R, Syed SB, Dadwal V, Bone LR, Ephraim PL, Weston CM, Wu AW; Baltimore CONNECT Project Team. From Kisiizi to Baltimore: cultivating knowledge brokers to support global innovation for community engagement in healthcare. Global Health. 2018 Feb 9;14(1):19. doi: 10.1186/s12992-018-0339-8.
- Individual participant dataSharing planned: No. No plan to share IPD with other researchers.
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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.
Albert W Wu, MD MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-developed IT intervention in people with Diabetes and Cardiovascular Disease, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 1 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Emergency Department Visits + Hospital Days (time frame: Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222909, which also lists 3 linked publications.
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 9 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.