NCT00787475

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

5.4 years

First QC Date

November 6, 2008

Last Update Submit

February 2, 2015

Conditions

Diabetes

Keywords

DiabetesCommunity health workerCommunity outreach

Outcome Measures

Primary Outcomes (1)

  • HgA1C level

    Up to 12 months

Secondary Outcomes (2)

  • Measurement of LDL

    Up to 12 months

  • Measurement of systolic blood pressure

    Up to 12 months

Study Arms (2)

1

EXPERIMENTAL

CHW intervention

Other: Community Health worker

2

NO INTERVENTION

Enhanced usual care (brochure mailings)

Interventions

Community Health workerOTHER

Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.

1

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • 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.

    PMID: 24496805RESULT

  • Palmas 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.

    PMID: 22454189DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Walter Palmas, MD

    Columbia University Medical Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

US(1)