NCT00577759

Brief Summary

The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

February 16, 2015

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

December 13, 2007

Last Update Submit

February 12, 2015

Conditions

Keywords

Quality assurance, health careprimary health carecommunity health servicesreferral and consultationexercisediettobacco

Outcome Measures

Primary Outcomes (1)

  • The number of referrals from the practices to the community resources

    6 months

Secondary Outcomes (3)

  • Number of referrals received by each resource

    6 months

  • The proportion of patients with unhealthy behaviors who were referred from the practices to community resources

    6 months

  • Practice attitudes and practice regarding referral to community resources

    6 months

Study Arms (3)

Active Intervention

EXPERIMENTAL

Direct referral to community organizations, with support for practices to do so. These include the North Carolina Tobacco Quitline, public health department dietitians, and the YMCA.

Other: Active Intervention

Passive Intervention

EXPERIMENTAL

Provision of information about community organizations to patients as above.

Other: Passive Intervention

Usual Care

PLACEBO COMPARATOR

Usual care

Other: No intervention

Interventions

Quality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources

Active Intervention

Provision of tools to help with referrals to community resources

Passive Intervention

No intervention

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Internal medicine and family practices in Durham and Orange counties, North Carolina

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27715, United States

Location

MeSH Terms

Conditions

Motor ActivityFeeding BehaviorTobacco Use Cessation

Condition Hierarchy (Ancestors)

BehaviorBehavior, AnimalHealth Behavior

Study Officials

  • Alex R Kemper, MD, MPH, MS

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 20, 2007

Study Start

February 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

February 16, 2015

Record last verified: 2012-10

Locations