View Clinical Trial (Medical Research Study)
Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
| City: |
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Rochester |
| State: |
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Minnesota |
| Zip Code: |
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55905 |
| Conditions: |
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Tobacco Cessation |
| Purpose: |
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This study is designed to examine if a telephone-based intervention delivered to a support
person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota
helpline. In addition, the study will examine if the rate of smoker calls to the helpline
is greater if the support person receives 3 intervention calls, 1 intervention call, or no
calls (written materials only, control condition).
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| Study Summary: |
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We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN®
Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling
for support persons (1 or 3 sessions) compared with a control condition on the proportion of
smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose
response relationship between number of telephone sessions provided to the support persons
and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and
cessation, and cost-effectiveness of the interventions.
Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and
randomly assigned to one of three study conditions: (1) control condition -written self-help
materials, (2) written materials plus one telephone session, or (3) written materials plus
three telephone sessions. Outcome assessments will be completed by support persons and
smokers at post-treatment (week 4) and at 7 month follow-up.
This design will allow for evaluation of whether results from our previous trial (Patten et
al., in press, AJPM) can be replicated when the intervention is implemented within a
"real-world" setting. That is all support person intervention calls will be delivered by
the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a
streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study
will provide new data on quit attempts and cessation among the smokers. Ultimately,
positive findings from this line of research could serve as the basis for expanding the
range of helpline services to nonsmokers.
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| Criteria: |
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Inclusion Criteria:
- The support person must
1. reside in Minnesota
2. be 18 years of age or older
3. provide written informed consent
4. be a never or former cigarette smoker (no cigarette smoking in the past 6
months)
5. want to support a current cigarette smoker (has smoked a total of >1 cigarettes
during the past 7 days) who is 18 years of age or older, resides in Minnesota,
and has not been enrolled in a helpline or any other cessation program in the
last 3 months
6. be able and willing to participate in all aspects of the study
7. have access to a working telephone
8. have current and anticipated contact (any combination of face-to-face,
telephone, text messaging, or electronic mail) with the smoker on at least 3
days a week for the 30 week study duration.
Exclusion Criteria:
- Support persons will be excluded if another support person from the same household
has enrolled.
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| NCT ID: |
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NCT01331226 |
| Primary Contact: |
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Christi A Patten, PhD
Phone: 507-538-7370
Email: patten.christi@mayo.edu
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| Backup Contact: |
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Email: smith.christina@mayo.edu
Christi M Smith
Phone: 507-266-2658
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| Location Contact: |
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Rochester, Minnesota 55905
United States
Christi A Patten, PhD
Phone: 507-538-7370
Email: patten.christi@mayo.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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