DiabetesNOCHOPNCT00787475
Northern Manhattan Diabetes Community Outreach Project
A study testing Community Health worker in people with Diabetes, run by Columbia University at 1 site in United States.
Trial summary
The objective of this study is to examine the effectiveness of a community health worker intervention at helping to control diabetes among Latinos with poorly controlled Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Community Health worker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2014
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients age 35-70 years*
- Receiving care at our clinic (2 visits with a primary care provider in the previous year)
- Living in Northern Manhattan or Western Bronx (based on zip codes)
- Had a hemoglobin A1C-done within the past year, with the latest value being > or = 8.0
Who cannot join
- Patients whose primary care physician (PCP) believes are not appropriate candidates for participation
- Type 1 diabetics (identified by PCP), as their care is quite distinct from that of Type II patients, and there are very few such patients in our clinic
- Patients with diabetes diagnosed when under age 25 ("new-onset" Type I diabetes) as such patients are extremely rare in our primary care clinics
- Patients who do not self-identify as Hispanic (Hispanics can be of any race e.g. white, black, mixed)
- Any life-threatening or extreme medical co-morbidity, such as an active cancer diagnosis, paraplegia, or end stage cardio-pulmonary disease
- Having a diabetes diagnosis for < 1 year, to ensure the stability of hemoglobin A1C values above 8.0
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- Planning to move out of the neighborhood during the next year
- Planning to travel out of the neighborhood for more than three consecutive months
- Enrollment in any other cardiovascular disease (CVD) or diabetes intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The objective of this study is to examine the effectiveness of a community health worker intervention at helping to control diabetes among Latinos with poorly controlled Type 2 diabetes.
Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density lipoprotein (LDL); and (3) systolic and diastolic BP.
Read the detailed description
The objective of this project is to examine the effectiveness of a community health worker (CHW) intervention at addressing glycemic control among Latinos with poorly controlled Type 2 diabetes. Our group has worked with a promising model of intervention that utilizes CHW's based at one of our major community partners. Pilot data from this program has shown clinically significant prepost test improvements in HgA1C. Using the Chronic Care Model as an overarching framework, the study design of NOCHOP is a randomized controlled trial of 360 Latinos, mostly of Caribbean descent, aged 35-70 years with HgA1C >=8.0. At a minimum, subjects in the intervention group will receive four home visits, ten group level visits and monthly phone calls by CHWs based at Alianza. The control groups will receive three separate mailings of bilingual diabetes health education materials. The primary outcome is glycemic control at 12month follow up, as measured by HgA1c. The secondary outcomes are changes in cholesterol and blood pressure (BP). We will also collect exploratory data on potential mechanisms through which our intervention resulted in hypothesized improvements including medication adherence, medication Intensification, diet and exercise. If successful, our project will make an important contribution to ongoing national and local debates about the sustainability of CHW programs. In particular, data from this study would be extremely useful for local Medicaid managed care plans who have expressed strong interests in data from rigorously designed clinical trials addressing the role of CHWs in delivering culturally appropriate and effective diabetes care.
- Conditions
- Diabetes
- Being tested
- Community Health worker
- Keywords
- Diabetes, Community health worker, Community outreach
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health workerOther
Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CHW intervention Receives: Other: Community Health worker |
| 2 | No intervention | Enhanced usual care (brochure mailings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HgA1C level
Measured: Up to 12 months
Secondary outcomes (2)
Measurement of LDL
Measured: Up to 12 months
Measurement of systolic blood pressure
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Walter Palmas, MD, MS, FAHA, Columbia University
- Investigators
- Walter Palmas, MD, Principal investigator, Columbia University Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787475
- Sponsor's protocol ID
- AAAD1689
- Other IDs
- MD00206P60
- Acronym
- NOCHOP
- Status last verified
- Feb 2015
- First submitted
- 6 Nov 2008
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmas W, Findley SE, Mejia M, Batista M, Teresi J, Kong J, Silver S, Fleck EM, Luchsinger JA, Carrasquillo O. Results of the northern Manhattan diabetes community outreach project: a randomized trial studying a community health worker intervention to improve diabetes care in Hispanic adults. Diabetes Care. 2014 Apr;37(4):963-9. doi: 10.2337/dc13-2142. Epub 2014 Feb 4.
PubMed 24496805Palmas W, Teresi JA, Findley S, Mejia M, Batista M, Kong J, Silver S, Luchsinger JA, Carrasquillo O. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults. BMJ Open. 2012 Mar 26;2(2):e001051. doi: 10.1136/bmjopen-2012-001051. Print 2012.
PubMed 22454189
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Manhattan Diabetes Community Outreach Project
- ClinicalTrials.gov ID
- NCT00787475
- Acronym / sponsor ID
- NOCHOP / AAAD1689
- Conditions
- Diabetes
- Keywords
- Diabetes, Community health worker, Community outreach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Nov 2008 (estimated)
- 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 objective of this study is to examine the effectiveness of a community health worker intervention at helping to control diabetes among Latinos with poorly controlled Type 2 diabetes.
Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density lipoprotein (LDL); and (3) systolic and diastolic BP.
Detailed description
The objective of this project is to examine the effectiveness of a community health worker (CHW) intervention at addressing glycemic control among Latinos with poorly controlled Type 2 diabetes. Our group has worked with a promising model of intervention that utilizes CHW's based at one of our major community partners. Pilot data from this program has shown clinically significant prepost test improvements in HgA1C. Using the Chronic Care Model as an overarching framework, the study design of NOCHOP is a randomized controlled trial of 360 Latinos, mostly of Caribbean descent, aged 35-70 years with HgA1C >=8.0. At a minimum, subjects in the intervention group will receive four home visits, ten group level visits and monthly phone calls by CHWs based at Alianza. The control groups will receive three separate mailings of bilingual diabetes health education materials. The primary outcome is glycemic control at 12month follow up, as measured by HgA1c. The secondary outcomes are changes in cholesterol and blood pressure (BP). We will also collect exploratory data on potential mechanisms through which our intervention resulted in hypothesized improvements including medication adherence, medication Intensification, diet and exercise. If successful, our project will make an important contribution to ongoing national and local debates about the sustainability of CHW programs. In particular, data from this study would be extremely useful for local Medicaid managed care plans who have expressed strong interests in data from rigorously designed clinical trials addressing the role of CHWs in delivering culturally appropriate and effective diabetes care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Community Health workerCHW intervention |
| 2 | No intervention | –Enhanced usual care (brochure mailings) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients age 35-70 years*
- Receiving care at our clinic (2 visits with a primary care provider in the previous year)
- Living in Northern Manhattan or Western Bronx (based on zip codes)
- Had a hemoglobin A1C-done within the past year, with the latest value being > or = 8.0
Key exclusion criteria (9 listed)
- Patients whose primary care physician (PCP) believes are not appropriate candidates for participation
- Type 1 diabetics (identified by PCP), as their care is quite distinct from that of Type II patients, and there are very few such patients in our clinic
- Patients with diabetes diagnosed when under age 25 ("new-onset" Type I diabetes) as such patients are extremely rare in our primary care clinics
- Patients who do not self-identify as Hispanic (Hispanics can be of any race e.g. white, black, mixed)
- Any life-threatening or extreme medical co-morbidity, such as an active cancer diagnosis, paraplegia, or end stage cardio-pulmonary disease
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 |
|---|---|---|
| Community Health workerCommunity Health workers with at least 4 home visits, 8 phone calls, and 10 group visits. | Other | 1 |
Primary outcome
HgA1C level
Time frame: Up to 12 months
2 secondary outcomes
Measurement of LDL
Time frame: Up to 12 months
Measurement of systolic blood pressure
Time frame: Up to 12 months
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 4 Feb 2015.
- Results publication: PubMed 24496805Palmas W, Findley SE, Mejia M, Batista M, Teresi J, Kong J, Silver S, Fleck EM, Luchsinger JA, Carrasquillo O. Results of the northern Manhattan diabetes community outreach project: a randomized trial studying a community health worker intervention to improve diabetes care in Hispanic adults. Diabetes Care. 2014 Apr;37(4):963-9. doi: 10.2337/dc13-2142. Epub 2014 Feb 4.
- Derived from this study: PubMed 22454189Palmas W, Teresi JA, Findley S, Mejia M, Batista M, Kong J, Silver S, Luchsinger JA, Carrasquillo O. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults. BMJ Open. 2012 Mar 26;2(2):e001051. doi: 10.1136/bmjopen-2012-001051. Print 2012.
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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.
Walter Palmas, MD principal investigator
Columbia University Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health worker in people with Diabetes, run by Columbia University 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 4 inclusion and 9 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 4 Feb 2015. 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?
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?
HgA1C level (time frame: Up to 12 months). 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 NCT00787475, which also lists 2 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 4 Feb 2015.