- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03174158
A Text Messaging Program for Smokers in Primary Care (GR2Q)
A Text Messaging Intervention for Smoking Cessation Among Community Health Center Patients
This study is a four arm pilot randomized controlled trial testing the effect of a 12 week text messaging intervention and a mailed nicotine medication intervention, alone and in combination to a control condition consisting of brief behavioral advice and usual care.
Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the effect of a text messaging program and mailed nicotine replacement therapy on smoking outcomes and medication use.
Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a quit attempt compared to smokers receiving no text messaging.
Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy.
Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects receiving no text messaging intervention.
Hypothesis 4: A text messaging intervention will increase the number of days not smoking compared to subjects receiving no text messaging intervention.
Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per day compared to subjects receiving no text messaging intervention.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Fifteen percent of U.S. adults continue to smoke despite the availability of effective smoking cessation treatment and healthcare systems are positioned to address this deficiency. Text messaging is a widespread technology which shows promise as a way to reach smokers and to connect them with treatment. Tobacco cessation support delivered by text message increases abstinence among smokers interested in quitting in community- or school-based settings. This has led to the creation of text messaging programs by the National Cancer Institute, SmokeFreeTXT, and others. However, little is known about the feasibility of delivering smoking cessation support by text message for smokers engaged in healthcare systems. Integrating text messaging programs within healthcare systems has clear advantages. Documentation of smoking status is one of the Meaningful Use standards. This documentation enables healthcare systems to identify their population of smokers and proactively target them with health interventions outside of the busy office visit. Text messaging programs originating from the physicians' practice may also leverage the influence physicians have on smokers' motivation to quit.
Text messaging has been used in healthcare systems to effectively improve medication adherence in other conditions. Adherence to smoking cessation medications is at least modestly associated with cessation and measures of adherence to smoking cessation medications suggest overall low adherence to cessation medications outside of clinical trials. Offering free nicotine replacement therapy along with the medication adherence advice in a text messaging intervention will allow us to evaluate of the effect of adherence messages on medication use.
Study design A pilot randomized controlled trial of 206 smokers who receive care in Massachusetts General Hospital-affiliated primary care practices will compare the effect of delivering behavioral smoking cessation content with pharmacotherapy support by text message plus nicotine replacement therapy on self-reported quit attempts (intentional non-smoking for ≥24 hours), medication adherence, days not smoked, and smoking abstinence at the end of treatment. Smokers will be identified using the electronic health record, screened by their primary care provider, and proactively contacted by telephone by a clinical research coordinator. Potential subjects will be screened for eligibility by self-report and chart review by the Principal Investigator. Eligible subjects will be stratified by practice and readiness to quit (plan to quit smoking in the next 30 days vs no plan to quit smoking/plan to quit smoking in the next 6 months) and randomized 1:1:1:1 to 4 groups using a variable block randomization.
- Brief advice (BA): Brief advice to quit smoking and usual care. Rationale: All subjects will receive brief advice from a trained clinical research coordinator. All primary care subjects also have access to guideline-concordant tobacco treatment through usual care with their primary care provider. Their primary care provider can refer them to in-person or telephone counseling and can prescribe medications.
- Nicotine replacement therapy (NRT): Brief advice + 2 weeks of nicotine patches and/or lozenges mailed to subject. Rationale: In order to test the effect of text messaging on medication adherence, we need to have treatment groups receiving medication and medication plus text messaging. To deliver medication, mailed NRT, like text messaging, reaches patients outside of the busy office visit. Mailed NRT alone has also been shown to increase cessation and may itself be an effective intervention compared to brief advice and usual care.
- Text messaging (TM): Brief advice + 12 week personalized, tailored text messaging program. Rationale: Text messaging shows promise as an intervention to help smokers to quit. However, it has not been well tested among primary care patients. Text messaging may connect those primary care smokers who do not access currently available treatment services like telephone counseling or prescribed medication with assistance outside of the clinic office.
- Text messaging and nicotine replacement therapy (TM+NRT): Brief advice + 12 week personalized, tailored text messaging program + 2 weeks of nicotine patches and/or lozenges mailed to subject. Rationale: As above, in order to test the effect of text messaging on medication adherence, we need to have treatment groups receiving medication and medication plus text messaging. Text messaging has been shown to increase medication adherence in other conditions and medication adherence is suboptimal among users of smoking cessation medications. Integrating text messaging within healthcare systems offers opportunities to coordinate with pharmacotherapy and this 4 group design allows us to test the effect of text messaging alone on smoking outcomes and the effect of text messaging on NRT use.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massacusetts General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults (≥18 years)
- Smoking status of current smoker in structured field of electronic health record (EHR)
- Language listed as English in EHR
- Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)
- PCP visit in the past 2 years
- Mobile telephone number listed in EHR
Exclusion Criteria:
- Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking
- Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
- Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.
- Past 30-day use of Massachusetts state quit-line, "QuitWorks" or SmokefreeTXT programs
- Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation
- Ever had an allergy to nicotine patch
- Weight < 100 pounds
- Unstable coronary disease
- Unstable arrhythmia
- Dementia or active psychosis or schizoaffective disorder affecting ability to consent
- Willing and able to receive and participate with a text message program for up to 12 weeks
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Brief advice
Usual care plus brief telephone advice to quit tobacco delivered by a clinical research coordinator who underwent Tobacco Treatment Specialist core training.
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Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
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Expérimental: Text messaging
Patients randomized to the text messaging program are offered a 12-week text messaging.
The text messaging intervention will use content from the National Cancer Institute's SmokeFreeTXT library, content for smokers not ready to quit from SmokeFreeTXT and a pilot feasibility study conducted by the PI, and new messages supporting nicotine replacement medication adherence.
The text messaging program will be personalized using subject's first name, the telephone number for the Massachusetts General Hospital (MGH) tobacco cessation counseling services and the Massachusetts state quitline.
Smokers receiving the intervention will be sent from 0 and 5 text messages per day.
|
Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
12 week text messaging program tailored to readiness to quit and quit date.
Program includes content encouraging NRT use.
Content is personalized with user's name and Massachusetts General Hospital resources.
|
Expérimental: Mailed nicotine replacement therapy
Subjects randomized to mailed nicotine replacement therapy will be offered a 2 week supply of nicotine replacement therapy mailed to their home address.
Daily smokers planning to quit in the next 30 days will be offered nicotine patches (14 or 21 mg patches) and lozenges (2 or 4 mg lozenges) dosed according to package instructions.
Non-daily smokers planning to quit will be offered a 2 week allotment of 2 mg lozenges alone.
Smokers not planning to quit will be offered one box of lozenges (72 count box of 4 mg or 2 mg lozenges based on time to first cigarette as above per package instructions) to use when they are not smoking during their practice quit attempt.
|
Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).
Non-daily smokers will be offered a 2 week supply of 2 mg lozenges.
Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
|
Expérimental: Text messaging + mailed NRT
Subjects will be offered both the 12 week text message program and 2 weeks of mailed nicotine replacement therapy.
|
Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
12 week text messaging program tailored to readiness to quit and quit date.
Program includes content encouraging NRT use.
Content is personalized with user's name and Massachusetts General Hospital resources.
Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).
Non-daily smokers will be offered a 2 week supply of 2 mg lozenges.
Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quit Attempts
Délai: End of treatment (12 week post-enrollment)
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Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more ("During the past 12 weeks, have you quit smoking intentionally for 1 day or longer").
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End of treatment (12 week post-enrollment)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
7 Day Point Prevalent Abstinence
Délai: 6 weeks post-enrollment
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Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?"
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6 weeks post-enrollment
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7 Day Point Prevalent Abstinence
Délai: 12 weeks post-enrollment (end of treatment)
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Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?"
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12 weeks post-enrollment (end of treatment)
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Milligrams of Nicotine Medication Used
Délai: week 2 post enrollment
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Self-reported milligrams of nicotine medication used
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week 2 post enrollment
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Percentage of Days Not Smoked
Délai: 12 weeks post-enrollment (end of treatment)
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Self-reported, "In the past 30 days, how many days did you have at least one cigarette?"
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12 weeks post-enrollment (end of treatment)
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Exhaled Carbon Monoxide
Délai: 12 weeks post-enrollment (end of treatment)
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Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million
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12 weeks post-enrollment (end of treatment)
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Days Nicotine Medication Used
Délai: Total reported over 2 weeks post-enrollment
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Self-reported number of days nicotine lozenge and/or patch used
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Total reported over 2 weeks post-enrollment
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Milligrams Nicotine Medication Used
Délai: Total reported over 1 week post-enrollment
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Self-reported number of milligrams nicotine medication used
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Total reported over 1 week post-enrollment
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Change in Cigarettes Per Day
Délai: 12 weeks post enrollment (end of treatment)
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Self-reported number of cigarettes per day on days smoked, change
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12 weeks post enrollment (end of treatment)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Gina R Kruse, MD, Massachusetts General Hospital
Publications et liens utiles
Publications générales
- Kruse GR, Park ER, Chang Y, Haberer JE, Abroms LC, Shahid NN, Howard S, Haas JS, Rigotti NA. Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1509-1514. doi: 10.1093/ntr/ntaa050.
- Kruse GR, Park E, Haberer JE, Abroms L, Shahid NN, Howard SE, Chang Y, Haas JS, Rigotti NA. Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol. Contemp Clin Trials. 2019 May;80:48-54. doi: 10.1016/j.cct.2019.03.006. Epub 2019 Mar 25.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2017P000960
- 1K23DA038717-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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