NCT01228032

Brief Summary

There is an urgent need to develop practical, sustainable approaches to improving medical care for persons treated in community mental health settings. This study will test a novel approach for improving mental health consumers based on a partnership model between a Community Mental Health Center and a Community Health Center. When this study is completed, it will provide a model for a medical home for persons with severe mental illness that is clinically robust, and organizationally and financially sustainable

Trial Health

87
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_3 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

April 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

5.3 years

First QC Date

October 22, 2010

Last Update Submit

February 25, 2016

Conditions

DiabetesHyperlipidemiaHeart DiseaseHigh Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Quality of healthcare services received

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Care team

Control

NO INTERVENTION

referral only

Interventions

Care teamOTHER

The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.

Also known as: randomized control
Intervention

Eligibility Criteria

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

You may qualify if:

  • Patient at Cobb County CSB
  • one or more of the following conditions: hyperlipidemia, high blood pressure, heart failure, diabetes
  • able to give consent

You may not qualify if:

  • unable to give consent
  • does not have a cardiometabolic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cobb County Community Service Board

Marietta, Georgia, 30008, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHyperlipidemiasHeart DiseasesHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism DisordersCardiovascular DiseasesVascular Diseases

Study Officials

  • Benjamin G Druss, MD MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

US(1)