Cardiovascular DiseasesNCT00101491
STORIES-Stories to Communicate Risk About Tobacco
A study testing Health Communication DVD video in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 78 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Health Communication DVD video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cooper Green Hospital
Birmingham, Alabama, 35233
University of Alabama
Birmingham, Alabama, 35294
About this study
Official title: Partnership Programs to Reduce Cardiovascular Disparities - Deep South Partnerships for Prevention of CVD Disparities
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Health Communication DVD video
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Communication DVD videoBehavioural
Interactive, testimonial-based, stage of change-matched Health Communication DVD video interventions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Health Communication DVD video |
| 2 | Other | Attention Control Comparator Receives: Behavioral: Health Communication DVD video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Measured: Measured at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Sandra Hullett, MD, MPH, Principal investigator, Cooper Green HospitalCatarina Kiefe, MD, PhD, Principal investigator, University of Alabama at BirminghamThomas K Houston, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101491
- Sponsor's protocol ID
- 1282
- Other IDs
- U01HL079153, U01HL079171
- Status last verified
- Feb 2009
- First submitted
- 10 Jan 2005
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cherrington A, Williams JH, Foster PP, Coley HL, Kohler C, Allison JJ, Kiefe CI, Volkman JE, Houston TK. Narratives to enhance smoking cessation interventions among African-American smokers, the ACCE project. BMC Res Notes. 2015 Oct 14;8:567. doi: 10.1186/s13104-015-1513-1.
PubMed 26467316
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership Programs to Reduce Cardiovascular Disparities - Deep South Partnerships for Prevention of CVD Disparities
- ClinicalTrials.gov ID
- NCT00101491
- Acronym / sponsor ID
- 1282
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Health Communication DVD video |
| 2 | Other | Behavioral: Health Communication DVD videoAttention Control Comparator |
Who may qualify
- Ages
- 19 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Communication DVD videoInteractive, testimonial-based, stage of change-matched Health Communication DVD video interventions | Behavioural | 1, 2 |
Primary outcome
Smoking cessation
Time frame: Measured at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Derived from this study: PubMed 26467316Cherrington A, Williams JH, Foster PP, Coley HL, Kohler C, Allison JJ, Kiefe CI, Volkman JE, Houston TK. Narratives to enhance smoking cessation interventions among African-American smokers, the ACCE project. BMC Res Notes. 2015 Oct 14;8:567. doi: 10.1186/s13104-015-1513-1.
- Alabama Collaboration for Cardiovascular Equality (ACCE) is an initiative under the leadership of Drs. Catarina Kiefe and Sandral Hullett and is comprised of STORIES (NCT00101491), led by Dr. Thomas Houston, and ADAPT (NCT00621569), led by Dr. Jamy Ard.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Hullett, MD, MPH principal investigator
Cooper Green Hospital
Catarina Kiefe, MD, PhD principal investigator
University of Alabama at Birmingham
Thomas K Houston, MD, MPH principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Communication DVD video in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: Measured at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00101491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.