Dataset Information

SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Homeless smokers want to quit smoking but face numerous barriers to doing so, including pervasive smoking among peers and a lack of social support for quitting. An SMS (short message service) text messaging intervention could address these challenges by providing virtual daily support for homeless smokers who are trying to quit but coping with multiple triggers to smoke. OBJECTIVE:This study aimed to assess whether a free SMS text messaging program, added to evidence-based pharmacotherapy and counseling, improved smoking abstinence among homeless adult smokers. METHODS:From October 2015 to June 2016, we conducted an 8-week pilot randomized controlled trial (RCT) of nicotine patch therapy and weekly in-person counseling with (n=25) or without (n=25) SmokefreeTXT, a free SMS text messaging service administered by the National Cancer Institute (NCI) at Boston Health Care for the Homeless Program. All participants were provided with a mobile phone and a 2-month prepaid voice and text plan at no cost. SmokefreeTXT enrollees were sent 1 to 5 automated SMS text messages daily for up to 8 weeks and could receive on-demand tips for managing cravings, mood symptoms, and smoking lapses. The primary outcome was smoking abstinence, defined as an exhaled carbon monoxide count of <8 parts per million, assessed 14 times over 8 weeks of follow-up, and analyzed using repeated-measures logistic regression with generalized estimating equations. Other outcomes were use of SmokefreeTXT, assessed by data obtained from NCI; perceptions of SmokefreeTXT, assessed by surveys and qualitative interviews; and mobile phone retention, assessed by self-report. RESULTS:Of the SmokefreeTXT arm participants (n=25), 88% (22) enrolled in the program, but only 56% (14) had confirmed enrollment for ?2 weeks. Among 2-week enrollees, the median response rate to interactive messages from SmokefreeTXT was 2.1% (interquartile range 0-10.5%). Across all time points, smoking abstinence did not differ significantly between SmokefreeTXT and control arm participants (odds ratio 0.92, 95% CI 0.30-2.84). Of SmokefreeTXT enrollees who completed exit surveys (n=15), two-thirds were very or extremely satisfied with the program. However, qualitative interviews (n=14) revealed that many participants preferred in-person intervention formats over phone-based, found the SMS text messages impersonal and robotic, and felt that the messages were too frequent and repetitive. Only 40% (10/25) of SmokefreeTXT arm participants retained their study-supplied mobile phone for the 8-week duration of the trial, with phone theft being common. Storing and charging phones were cited as challenges. CONCLUSIONS:SmokefreeTXT, added to nicotine patch therapy and in-person counseling, did not significantly improve smoking abstinence in this 8-week pilot RCT for homeless smokers. SMS text messaging interventions for this population should be better tuned to the unique circumstances of homelessness and coupled with efforts to promote mobile phone retention over time. TRIAL REGISTRATION:ClinicalTrials.gov NCT02565381; https://clinicaltrials.gov/ct2/show/NCT02565381 (Archived by WebCite at http://www.webcitation.org/78PLpDptZ).

SUBMITTER: Baggett TP

PROVIDER: S-EPMC6746087 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial.

Baggett Travis P TP McGlave Claire C Kruse Gina R GR Yaqubi Awesta A Chang Yuchiao Y Rigotti Nancy A NA

JMIR mHealth and uHealth 20190604 6

<h4>Background</h4>Homeless smokers want to quit smoking but face numerous barriers to doing so, including pervasive smoking among peers and a lack of social support for quitting. An SMS (short message service) text messaging intervention could address these challenges by providing virtual daily support for homeless smokers who are trying to quit but coping with multiple triggers to smoke.<h4>Objective</h4>This study aimed to assess whether a free SMS text messaging program, added to evidence-ba ...[more]

PMID: 31165717

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Project description:Introduction:Three-quarters of homeless people smoke cigarettes. Financial incentives for smoking abstinence have appeared promising in nonexperimental studies of homeless smokers, but randomized controlled trial (RCT) data are lacking. Methods:We conducted a pilot RCT of financial incentives for homeless smokers. Incentive arm participants (N = 25) could earn escalating $15-$35 rewards for brief smoking abstinence (exhaled carbon monoxide <8 parts per million) assessed 14 times over 8 weeks. Control arm participants (N = 25) were given $10 at each assessment regardless of abstinence. All participants were offered nicotine patches and counseling. The primary outcome was a repeated measure of brief smoking abstinence across 14 assessments. The secondary outcome was brief abstinence at 8 weeks. Exploratory outcomes were self-reported 1-day and 7-day abstinence from (1) any cigarette and (2) any puff of a cigarette. Other outcomes included 24-hour quit attempts, nicotine patch use, counseling attendance, and changes in alcohol and drug use. Results:Compared to control, incentive arm participants were more likely to achieve brief abstinence overall (odds ratio 7.28, 95% confidence interval 2.89 to 18.3) and at 8 weeks (48% vs. 8%, p = .004). Similar effects were seen for 1-day abstinence, but 7-day puff abstinence was negligible in both arms. Incentive arm participants made more quit attempts (p = .03). Nicotine patch use and counseling attendance were not significantly different between the groups. Alcohol and drug use did not change significantly in either group. Conclusions:Among homeless smokers, financial incentives increased brief smoking abstinence and quit attempts without worsening substance use. This approach merits further development focused on promoting sustained abstinence. Registration:ClinicalTrials.gov (NCT02565381). Implications:Smoking is common among homeless people, and conventional tobacco treatment strategies have yielded modest results in this population. This pilot RCT suggests that financial incentives may be a safe way to promote brief smoking abstinence and quit attempts in this vulnerable group of smokers. However, further development is necessary to translate this approach into real-world settings and to promote sustained periods of smoking abstinence.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundAround 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support.ObjectiveThis study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program) among Chinese male smokers.MethodsChinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program.ResultsThe program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00.ConclusionsOur program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest.Trial registrationANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx.International registered report identifier (irrid)RR2-18071.

Project description:BACKGROUND:Although smoking cessation apps have become popular, few have been tested in randomized clinical trials or undergone formative evaluation with target users. OBJECTIVE:We developed a cessation app targeting tobacco-dependent cancer patients. Game design and behavioral rehearsal principles were incorporated to help smokers identify, model, and practice coping strategies to avoid relapse to smoking. In this randomized pilot trial, we examined feasibility (recruitment and retention rates), acceptability (patient satisfaction), quitting self-confidence, and other cessation-related indices to guide the development of a larger trial. METHODS:We randomized 42 English-speaking cancer patients scheduled for surgical treatment to either the Standard Care (SC; telecounseling and cessation pharmacotherapies) or the experimental QuitIT study arm (SC and QuitIT game). Gameplay parameters were captured in-game; satisfaction with the game was assessed at 1-month follow-up. We report study screening, exclusion, and refusal reasons; compare refusal and attrition by key demographic and clinical variables; and report tobacco-related outcomes. RESULTS:Follow-up data were collected from 65% (13/20) patients in the QuitIT and 61% (11/18) in SC arms. Study enrollees were 71% (27/38) females, 92% (35/38) white people, and 95% (36/38) non-Hispanic people. Most had either lung (12/38, 32%) or gastrointestinal (9/38, 24%) cancer. Those dropping out were less likely than completers to have used a tablet (P<.01) and have played the game at all (P=.02) and more likely to be older (P=.05). Of 20 patients in the QuitIT arm, 40% (8/20) played the game (system data). There were no differences between those who played and did not play by demographic, clinical, technology use, and tobacco-related variables. Users completed an average of 2.5 (SD 4.0) episodes out of 10. A nonsignificant trend was found for increased confidence to quit in the QuitIT arm (d=0.25, 95% CI -0.56 to 1.06), and more participants were abstinent in the QuitIT group than in the SC arm (4/13, 30%, vs 2/11, 18%). Satisfaction with gameplay was largely positive, with most respondents enjoying use, relating to the characters, and endorsing that gameplay helped them cope with actual smoking urges. CONCLUSIONS:Recruitment and retention difficulties suggest that the perihospitalization period may be a less than ideal time for delivering a smoking cessation app intervention. Framing of the app as a "game" may have decreased receptivity as participants may have been preoccupied with hospitalization demands and illness concerns. Less tablet experience and older age were associated with participant dropout. Although satisfaction with the gameplay was high, 60% (12/20) of QuitIT participants did not play the game. Paying more attention to patient engagement, changing the intervention delivery period, providing additional reward and support for use, and improving cessation app training may bolster feasibility for a larger trial. TRIAL REGISTRATION:ClinicalTrials.gov NCT01915836; https://clinicaltrials.gov/ct2/show/NCT01915836 (Archived by WebCite at http://www.webcitation.org/73vGsjG0Y).

Dataset Information

SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial.

Publications

SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial.

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