NCT00222703

Brief Summary

The primary aim of this study is to examine the efficacy of a 12-week nurse-delivered relapse management intervention designed with conceptual underpinnings from Self-efficacy Theory to enhance smoking abstinence of hospitalized smokers following their hospital discharge. Specifically this study asks, does a 12-week Self-efficacy Theory driven relapse management intervention enhance smoking abstinence following hospitalization by increasing smoking abstinence point prevalence as measured by carbon monoxide validated self-reports of smoking, when compared to subjects receiving only enhanced usual care?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2002

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

Keywords

nicotine addictionrelapsesmokingchronic disordersrandomized controlled trialintervention

Outcome Measures

Primary Outcomes (1)

  • Self reported smoking status validated by exhaled CO

Secondary Outcomes (1)

  • Time to smoking lapse

Interventions

Eligibility Criteria

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

You may qualify if:

  • smoked one cigarette within 30 days of hospital admission
  • admission to a medical/surgical patient care unit
  • years of age or older

You may not qualify if:

  • diagnosis of cancer in a terminal state,
  • under evaluation for organ transplantation or awaiting transplantation,
  • cerebral vascular disorders,
  • senile dementia,
  • Alzheimer's disease,
  • abstinence from smoking greater than one month,
  • non-English speaking,
  • lack of a home telephone,
  • lack of a mailing address,
  • lack of any ability to participate with self-care activities,
  • and transfer to a rehabilitation hospital or nursing home following their hospital admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Chronic DiseaseTobacco Use DisorderRecurrenceSmoking

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Donna D Caruthers, PHD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

May 1, 2002

Study Completion

March 1, 2005

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations