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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00101491
Other study ID # 1282
Secondary ID U01HL079153U01HL
Status Completed
Phase N/A
First received January 10, 2005
Last updated July 11, 2016
Start date September 2004
Est. completion date August 2010

Study information

Verified date February 2009
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop and test an intervention based on literacy-appropriate electronic tools, tailored to the demographics and readiness for change of the user, to promote tobacco smoking cessation in a low-literacy population.


Description:

PROJECT STORIES:

STORIES is one of two intervention trials conducted as part of the "Deep South Partnership for the Prevention of CVD Disparities" under the NHLBI Partnership Programs to Reduce Cardiovascular Disparities. STORIES is an innovative approach to smoking cessation programs provided in medical facilities for patients seeking assistance with quitting smoking. Our approach is to provide the patient with counseling prior to being discharged from the hospital in an effort to assist them with quitting smoking. The DVD will include current and previous smokers telling their stories regarding their tobacco use. We feel having the patient see other people similar to them express their views, struggles and successes with quitting smoking will motivate them to quit smoking. The patient will also receive 3 follow up telephone calls to check on their progress. Our hypothesis is that patients exposed to the interactive DVD will be more likely to quit, compared with those not exposed. The specific aims for this health communication project are: (1) to develop a series of interactive, testimonial-base stage of change-matched Health Communication DVD video interventions targeted at low-income, low-literacy African Americans in the Deep South and a health information interactive DVD for the patients selected in the randomized control group; (2) to train a peer health counselor/research assistant to counsel inpatient smokers to quit and assist the community members with learning to use the DVDs and then to follow-up by telephone at two weeks, three months and six months after discharge following enrollment in the project; and (3) to evaluate the impact of the intervention on processes of change and six month cessation rates among smokers using a group-randomized controlled trial.

The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR) record.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date August 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 78 Years
Eligibility African American inpatients receiving treatment in the medicine unit who desire to quit smoking.

Inclusion Criteria:

- African Americans

- Patients not previously video/interviewed talking about smoking and health

- Patients willing to provide contact information for follow up

- Patients that are able to hear, view and communicate their input on material

Exclusion Criteria:

- Patients other than African American

- Admitted with issues of alcohol, drugs, and mentally unstable

- Patients leaving the state after hospitalization

- Patients without contact information for follow up

- Patients below age 19

- Non smokers

- Patients that use chewing tobacco

- Patients that are incarcerated

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Communication DVD video
Interactive, testimonial-based, stage of change-matched Health Communication DVD video interventions

Locations

Country Name City State
United States Cooper Green Hospital Birmingham Alabama
United States University of Alabama Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation Measured at 6 months No
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