- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00379054
Intervention for Support Persons to Help Smokers Quit
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Interventions that reach the majority of cigarette smokers in the population have the greatest potential to impact the public health. Most smokers do not seek treatment for smoking cessation. A novel behavioral approach to reaching smokers is to directly recruit and train adult nonsmokers to intervene (i.e., support persons). Several studies provide evidence for the role of social support in smoking cessation. The use of support persons as change agents for smoking cessation represents a shift from conventional interventions that focus almost exclusively on the smoker. This proposal builds on our previous work that indicates a skills training intervention for support persons is feasible and acceptable to participants. Moreover, the effect size observed for the smoking abstinence rate in the smokers, as reported by the support persons, provides some evidence of potential efficacy. However, the intensive, group, clinic-based format of the intervention limits its potential dissemination. We propose to develop and pilot test a more streamlined version of the intervention using a telephone-based format. To enhance internal validity of the findings, additional formative work is also needed to examine the feasibility of obtaining baseline assessments and outcomes directly from the smoker. Social cognitive theory is the conceptual basis for the proposed intervention.
The objective of this R21 proposal is to develop and pilot test a novel behavioral approach to smoking cessation that utilizes support persons in the smoker's natural environment. We expect that as a result of this project, we will have developed a well-specified and feasible telephone counseling intervention, the efficacy of which can be tested in future larger-scale randomized clinical trials.
This project will take place in two phases. In Phase 1, we will develop a telephone counseling intervention for support persons, adapting and refining the intervention from our previous, clinic-based treatment study. During this phase, we will develop the telephone counselor manual, and 10 support persons will complete the protocol, which will be modified and refined based on feedback from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply a randomized, two group design with repeated assessments at weeks 0 (baseline), 10 (end-of-treatment), and 26. Support persons (N=60) will be recruited and randomly assigned to self-help intervention or telephone counseling. The smokers will be enrolled as study subjects but will be contacted for assessments only.
Studietype
Registrering
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- MAYO
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
To be eligible, the support person must (1) be 18 years of age or older, (2) provide written informed consent, (3) be a never or former cigarette smoker (no cigarette use during the past 6 months), (4) be interested in helping someone 18 years of age who is a current smoker (average of 10 cigarettes per day in the past 7 days), (5) be able and willing to participate in all aspects of the study, (6) have current and anticipated contact (any combination of face-to-face, telephone, or electronic mail) with the smoker a total of at least 4 days of the week for the study duration, and (7), the smoker provides informed consent for the support person's involvement in the study.
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Exclusion Criteria:
(1) another support person from the same household has enrolled, (2) another support person has enrolled to help the same smoker, or (3) the smoker is currently (past 30 days) receiving pharmacologic or behavioral treatment for nicotine dependence.
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Feasibility (recruitment and retention of support persons and smokers),
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acceptability of intervention to support persons, potential efficacy
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(determined by number of smoker quit attempts, smoking abstinence, readiness
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to quit)and changes in supportive behaviors among the support persons as
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measured by the Support Provided Measure.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christi A Patten, Ph.D., Mayo Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1928-04
- 5R21DA018365-02 (U.S. NIH-stipend/kontrakt)
- 1R21DA018365-01 (U.S. NIH-stipend/kontrakt)
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