Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial

Background Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7723-z

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Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial (Preprint)

10.2196/preprints.27162 ◽

2021 ◽

Author(s):

Philipp Schwaninger ◽

Corina Berli ◽

Urte Scholz ◽

Janina Lüscher

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

The Self ◽

Daily Smoking ◽

Control Group ◽

Smoking Abstinence ◽

Self Monitoring ◽

Randomized Controlled

BACKGROUND Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (<i>buddy</i>) in daily life. OBJECTIVE The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. METHODS A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. RESULTS A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. CONCLUSIONS Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. CLINICALTRIAL ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7723-z

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Effects of a Mobile App Called Quittr, Which Utilizes Premium Currency and Games Features, on Improving Engagement With Smoking Cessation Intervention: Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.23734 ◽

2020 ◽

Author(s):

Ivan Bindoff ◽

Tristan R Ling ◽

Peter Gee ◽

Benjamin Geelan ◽

Stuart G Ferguson ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

Smoking Cessation Intervention ◽

Control Group ◽

Randomized Controlled ◽

Cessation Intervention ◽

Quit Rate ◽

Mhealth Apps

BACKGROUND Numerous mobile health (mHealth) apps have been developed to support smokers attempting to quit smoking. Although these apps have been reported to be successful, only modest improvements in the quit rate have been measured. It has been proposed that efforts to improve user engagement and retention may improve the quit rate further. Owing to the high cost of smoking-related disease, it is considered worthwhile to pursue even small improvements. OBJECTIVE The aim of this study was to test a novel smartphone app that leverages premium currency strategies developed by the mobile games industry in an attempt to improve engagement and retention with a smoking cessation intervention. METHODS We designed and developed a smoking cessation app called “Quittr” in line with previously developed smoking cessation mHealth apps. In addition to this established framework, we added a stand-alone fully featured city-building clicker-style game called “Tappy Town,” and a premium virtual currency called “QuitCoins.” The user earns QuitCoins for using the app in a way that contributes positively toward their quit attempt, and they can redeem these coins in Tappy Town for bonuses. To establish whether these features improved engagement and retention, we ran a 5-month randomized controlled trial where the intervention group had the full app with the extra games features, while the control group had the standard app only. Recruitment was performed via web-based advertising. Participants (N=175) had no direct contact with the researchers or other support staff. RESULTS No significant differences in terms of engagement, retention, or smoking outcomes were found between the control and intervention groups. However, survey data indicated that the majority of the participants valued Tappy Town (10/17, 59%) and the QuitCoins rewards system (13/17, 77%). Usage data also suggested that Tappy Town was widely played and was generally appealing to users (mean total time spent in app, control group: 797 seconds vs intervention group: 3502 seconds, <i>P<</i>.001). Analysis of the results suggests that users in the intervention group may have been negatively affected by the aspects of the chosen design, and some theories were explored to explain this unexpected outcome. CONCLUSIONS Although the novel features of the Quittr app failed to improve the key outcomes measured in this study, there were enough positive indications to warrant further exploration of the concept. Additional research will be required to identify and correct any design flaws that may have adversely affected our participants before a follow-up study can be completed. CLINICALTRIAL Australian and New Zealand Clinical Trials Register ACTRN12617000491369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372661&isReview=true

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Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial (Preprint)

10.2196/preprints.12835 ◽

2018 ◽

Author(s):

Francesc X Marin-Gomez ◽

Rocio Garcia-Moreno Marchán ◽

Anabel Mayos-Fernandez ◽

Gemma Flores-Mateo ◽

Esther Granado-Font ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Tobacco Use ◽

Controlled Trial ◽

Intervention Group ◽

Serious Game ◽

Control Group ◽

Randomized Controlled ◽

Pregnant Smokers

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)

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Project SUCCESS: Results from a Randomized Controlled Trial

ISRN Public Health ◽

10.5402/2012/913713 ◽

2012 ◽

Vol 2012 ◽

pp. 1-9 ◽

Cited By ~ 3

Author(s):

Karen S. Calabro ◽

Salma Marani ◽

Tracey Yost ◽

Janice Segura ◽

Mary Mullin Jones ◽

...

Keyword(s):

College Students ◽

Randomized Controlled Trial ◽

Smoking Cessation ◽

Smoking Status ◽

Nicotine Patch ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Intervention Condition

The present investigation tested whether an enhanced smoking cessation program produced higher cessation rates for participants than for controls. Participants in the enhanced intervention condition received in-person motivational counseling with health feedback, a tailored internet-based program, and nicotine patch. Participants in the control group received a smoking cessation self-help manual and nicotine patch. This randomized controlled trial was conducted at a 4-year university with a student body of 32,000. Five hundred-nine students who smoked ≥1 cigarette daily were individually randomized into the enhanced intervention and control groups. Over a 3-month period, participants in the enhanced intervention condition attended two personal sessions with smoking cessation counselors. Participants in both conditions were reassessed for smoking status 12 months post-baseline. Multivariate logistic regression techniques were used to analyze the data using the intent to treat approach. Results indicated that the odds of smoking cessation were 2 times larger for the enhanced intervention group than controls (odds ratio = 2.3, 95%, confidence interval = 1.3, 3.9, P<.01). This study begins to fill research gaps regarding college students and smoking cessation. Suggestions for future advancements in smoking cessation interventions for college students are provided.

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Feasibility and Acceptability of a smoking cessation smartphone app in older persons: eQUIT, a pilot randomized controlled trial (Preprint)

10.2196/preprints.24976 ◽

2020 ◽

Author(s):

Jenny Peek ◽

Karen Hay ◽

Pauline Hughes ◽

Adrienne Kostellar ◽

Subodh Kumar ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Number Needed To Treat ◽

Smoking Abstinence ◽

High Quality ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

BACKGROUND Although many smoking cessation smartphone apps exist, few have been independently evaluated, particularly in older populations. In 2017, of 112 commercially available smoking cessation apps available in Australia, only six were deemed high quality, in that they partially adhered to Australian guidelines. mHealth apps have the potential to modify smoking behaviour at relatively low cost, but acceptability in older smokers is unknown. Rigorous scientific evaluation of apps is urgently needed to assist smokers and clinicians alike. OBJECTIVE We conducted a pilot randomized controlled trial to assess the feasibility of a large-scale trial to assess the use and acceptability of a high-quality smoking cessation app in older smokers METHODS Adult inpatient and outpatient smokers with computer and smartphone access were recruited face to face and via telephone from Metropolitan Hospitals in Brisbane, Australia. Participants were randomized 1:1 to the “My QuitBuddy” smoking cessation app (intervention) or the tailored smoking cessation support web site “Quit HQ” (control). The My QuitBuddy app is freely available from app stores and provides personalised evidenced based smoking cessation support. Quit HQ offers regular email support over twelve weeks. No training or instructions in the use of the e-resources was given to participants. Outcomes at three months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile Application Rating Scale (uMARS)), changes in quitting motivation (10-point scale) and self-reported smoking abstinence. RESULTS We randomized 64 of 231 potentially eligible individuals (27.7%). Mean age was 62 years. Nicotine dependence was moderate (mean Heaviness of Smoking Index 2.8 (SD 1.2)). At three-months, follow-up was 91%. Fifteen intervention arm participants (52%) used the app at least once, compared to ten (34%) in the control arm (p=0.29). E-resource uMARS scores were statistically similar. Motivation to quit was significantly higher in the intervention arm compared to the control arm (median 6 [IQR 4-8] versus 4 [IQR 4-5] respectively, p=0.02). Smoking abstinence was non-significantly higher in the intervention group n=4, (13%, [95% CI: 4-30%] versus n=2, 6% [95% CI: 1-20%], p=0.42, ITT analysis). The estimated number needed to treat was 15. CONCLUSIONS Internet and mHealth smoking cessation resources appear acceptable to a minority of older smokers. However, whilst smokers who engaged with the allocated e-resources rated them equally, there were trends towards greater uptake, increased motivation and higher abstinence rates in the app group, although only the change in motivation reached statistical significance. This pilot study suggests apps may improve quit outcomes in older adults who are willing to use them. Further research into user-app interactions should be undertaken to facilitate improvements in app design and consumer engagement. These favourable trends should be explored in larger trials with sufficient statistical power. CLINICALTRIAL Trial Registration: Australian and New Zealand Clinical Trials Register (ACTRN12619000159156)

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Effects of a Mobile App Called Quittr, Which Utilizes Premium Currency and Games Features, on Improving Engagement With Smoking Cessation Intervention: Pilot Randomized Controlled Trial

JMIR Serious Games ◽

10.2196/23734 ◽

2020 ◽

Vol 8 (4) ◽

pp. e23734

Author(s):

Ivan Bindoff ◽

Tristan R Ling ◽

Peter Gee ◽

Benjamin Geelan ◽

Stuart G Ferguson ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

Randomized Controlled ◽

Cessation Intervention ◽

Quit Rate ◽

Mhealth Apps

Background Numerous mobile health (mHealth) apps have been developed to support smokers attempting to quit smoking. Although these apps have been reported to be successful, only modest improvements in the quit rate have been measured. It has been proposed that efforts to improve user engagement and retention may improve the quit rate further. Owing to the high cost of smoking-related disease, it is considered worthwhile to pursue even small improvements. Objective The aim of this study was to test a novel smartphone app that leverages premium currency strategies developed by the mobile games industry in an attempt to improve engagement and retention with a smoking cessation intervention. Methods We designed and developed a smoking cessation app called “Quittr” in line with previously developed smoking cessation mHealth apps. In addition to this established framework, we added a stand-alone fully featured city-building clicker-style game called “Tappy Town,” and a premium virtual currency called “QuitCoins.” The user earns QuitCoins for using the app in a way that contributes positively toward their quit attempt, and they can redeem these coins in Tappy Town for bonuses. To establish whether these features improved engagement and retention, we ran a 5-month randomized controlled trial where the intervention group had the full app with the extra games features, while the control group had the standard app only. Recruitment was performed via web-based advertising. Participants (N=175) had no direct contact with the researchers or other support staff. Results No significant differences in terms of engagement, retention, or smoking outcomes were found between the control and intervention groups. However, survey data indicated that the majority of the participants valued Tappy Town (10/17, 59%) and the QuitCoins rewards system (13/17, 77%). Usage data also suggested that Tappy Town was widely played and was generally appealing to users (mean total time spent in app, control group: 797 seconds vs intervention group: 3502 seconds, P<.001). Analysis of the results suggests that users in the intervention group may have been negatively affected by the aspects of the chosen design, and some theories were explored to explain this unexpected outcome. Conclusions Although the novel features of the Quittr app failed to improve the key outcomes measured in this study, there were enough positive indications to warrant further exploration of the concept. Additional research will be required to identify and correct any design flaws that may have adversely affected our participants before a follow-up study can be completed. Trial Registration Australian and New Zealand Clinical Trials Register ACTRN12617000491369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372661&isReview=true

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Smoking cessation with smartphone applications (SWAPP): study protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-019-7723-z ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 2

Author(s):

Janina Lüscher ◽

Corina Berli ◽

Philipp Schwaninger ◽

Urte Scholz

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Smoking Abstinence ◽

Smartphone Apps ◽

Randomized Controlled ◽

Quit Smoking

Abstract Background Tobacco smoking remains one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real-time. The social context of smokers has, however, been neglected in smartphone apps promoting smoking cessation. This randomized controlled trial investigates the effectiveness of a smartphone app in which smokers quit smoking with the help of a social network member. Methods This protocol describes the design of a single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Participants of this study are adult smokers who smoke at least one cigarette per day and intend to quit smoking at a self-set quit date. Blocking as means of group-balanced randomization is used to allocate participants to intervention or control conditions. Both intervention and control group use a smartphone-compatible device for measuring their daily smoking behavior objectively via exhaled carbon monoxide. In addition, the intervention group is instructed to use the SmokeFree Buddy app, a multicomponent app that also facilitates smoking-cessation specific social support from a buddy over a smartphone application. All participants fill out a baseline diary for three consecutive days and are invited to the lab for a background assessment. They subsequently participate in an end-of-day diary phase from 7 days before and until 20 days after a self-set quit date. Six months after the self-set quit date a follow-up diary for three consecutive days takes place. The primary outcome measures are daily self-reported and objectively-assessed smoking abstinence and secondary outcome measures are daily self-reported number of cigarettes smoked. Discussion This is the first study examining the effectiveness of a smoking cessation mobile intervention using the SmokeFree Buddy app compared to a control group in a real-life setting around a self-set quit date using a portable objective measure to assess smoking abstinence. Opportunities and challenges with running studies with smoking participants and certain design-related decisions are discussed. Trial registration This trial was prospectively registered on 04/04/2018 at ISRCTNregistry: ISRCTN11154315.

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Potentials and barriers of using digital tools for collecting daily measurements in multiple sclerosis research

Digital Health ◽

10.1177/20552076211055552 ◽

2021 ◽

Vol 7 ◽

pp. 205520762110555

Author(s):

Westergaard Katrine ◽

Signe Baattrup Ritzel ◽

Krogh Caroline ◽

Lynning Marie ◽

Bergien Sofie Olsgaard ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Outcome Measurement ◽

Controlled Trial ◽

The Self ◽

Digital Tools ◽

Control Group ◽

Unintended Effects ◽

Self Monitoring ◽

Randomized Controlled

Objective Digital tools offer new ways of collecting outcome data in intervention research. Little is known about the potentials and barriers of using such tools for outcome measurement in multiple sclerosis trials. This study aimed to examine reporting adherence and barriers experienced by people with multiple sclerosis in an intervention study using three different digital tools for outcome measurement. Methods This was a mixed-methods study conducted in the context of a randomized controlled trial. Data collected during the randomized controlled trial were analysed to assess reporting adherence. Twenty-three semi-structured, in-depth interviews were conducted to investigate randomized controlled trial participants’ experiences. Results Reporting adherence was high for all three measurement tools, but lower in the control group. Four main barriers were defined: (1) the self-monitoring aspect and repeated tests imbedded in the digital tools affected participants’ behavior during the randomized controlled trial. (2) Self-monitoring caused some participants to worry more about their health. (3) Passively collected data did not always correspond with participants’ own experiences, which caused them to question the validity of the collected data. (4) Daily reporting using different digital tools placed a significant burden on participants. Conclusion The study indicates a high reporting adherence using digital tools among people with multiple sclerosis. However, future studies should carefully consider the overall burden imposed on participants when taking this approach. Measures should be taken to avoid the potential unintended effects of the self-monitoring and gamification aspects of using digital tools. These measures could include passive monitoring, reducing the frequency of reporting and blinding participants to their own data.

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Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215516673208 ◽

2016 ◽

Vol 31 (8) ◽

pp. 1049-1056 ◽

Cited By ~ 10

Author(s):

Yoko Fujimaki ◽

Koichi Tsunoda ◽

Rika Kobayashi ◽

Chong Tonghyo ◽

Fujinobu Tanaka ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Vocal Cord ◽

Controlled Trial ◽

Intervention Group ◽

The Self ◽

Control Group ◽

Maximum Phonation Time ◽

Randomized Controlled ◽

Glottal Closure ◽

Significant Difference

Objectives: To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Design: Parallel-arm, individual randomized controlled trial. Methods: Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Results: Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly ( p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference ( p < 0.001). Conclusion: The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. Clinical Trial.gov Identifier-UMIN000015567

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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