A Randomized Controlled Trial of the Web-Based Drinking Diary Program (SNAPPY-DOC Program) for Problem Drinkers in Multi Workplace Settings (Preprint)

2020 ◽  
Author(s):  
Takashi Sunami ◽  
Ryuhei So ◽  
Hironobu Ishii ◽  
Eiji Sadashima ◽  
Takefumi Ueno ◽  
...  

BACKGROUND In recent years, web-based interventions for problem drinkers have been developed, and they appear to be effective in reducing alcohol consumption in some studies. However, most of the subjects included in the studies were students or those who were recruited through web advertisements, and the dropout rates were high. OBJECTIVE This study aimed to assess the effectiveness of a web-based brief intervention (BI) program to record daily drinking among problem drinkers in a workplace setting. METHODS A two-armed, parallel-group, randomized controlled trial was conducted at six workplaces in Japan. A one-off 30-minute face-to-face lecture was organized at each workplace, and the study was explained. The audience who wished to participate were asked to provide their written consent immediately after the one-off lecture. Among those who wished to participate, problem drinkers with an Alcohol Use Disorders Identification Test (AUDIT) score of eight or higher were randomly assigned into two groups. The participants allocated to the intervention group recorded their daily alcohol consumption for four weeks using SNAPPY-DOC, while those allocated to the control group received no intervention. Outcome measures included the amount of alcohol consumption in past seven days using the Timeline Follow-Back (TLFB) method in SNAPPY-DOC at baseline (Week 0), 8th week (Week 8), and 12th week (Week 12) and written AUDIT score at baseline (Week 0) and 12th week (Week 12). If there was no login to the program at baseline (Week 0), 8th week (Week 8), and 12th week (Week 12), the researcher sent a reminder email to the participant one week later requesting a record. If there was still no response, a further week later, the researcher contacted the participants through the occupational health professionals or other personnel in their respective workplaces to request a record. RESULTS Hundred participants were assigned to either the intervention group (n=50) or the control group (n=50). All the participants logged into the program, and no participants dropped out of the follow-up. The results of two-way repeated measures ANOVA showed a statistically significant interaction between the Group and the Week factors in the two primary outcomes (number of alcohol-free days in the past seven days, total drinks in the past seven days in standard units) and secondary outcomes (AUDIT score) (P=.04, .02, and .03, respectively). The intervention group had reduced alcohol consumption from 329 g to 246 g per week on average at the 12-week evaluation (P<.001), while the control group had reduced from 294 g to 276 g per week on average (P=.83). CONCLUSIONS The web-based BI program for problem drinkers (SNAPPY-DOC program) was considered to be low-cost, effective, and acceptable for implementation in actual workplace settings. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000037698; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042703

2020 ◽  
Author(s):  
Takashi Sunami ◽  
Ryuhei So ◽  
Hironobu Ishii ◽  
Eiji Sadashima ◽  
Takefumi Ueno ◽  
...  

BACKGROUND In recent years, web-based interventions for problem drinkers have been developed, and they appear to be effective in reducing alcohol consumption in some studies. However, most of the subjects included in the studies were students or those who were recruited through web advertisements, and the dropout rates were high. OBJECTIVE This study aimed to assess the effectiveness of a web-based brief intervention (BI) program to record daily drinking among problem drinkers in a workplace setting. METHODS A two-armed, parallel-group, randomized controlled trial was conducted at six workplaces in Japan. A one-off 30-minute face-to-face lecture was organized at each workplace, and the study was explained. The audience who wished to participate were asked to provide their written consent immediately after the one-off lecture. Among those who wished to participate, problem drinkers with an Alcohol Use Disorders Identification Test (AUDIT) score of eight or higher were randomly assigned into two groups. The participants allocated to the intervention group recorded their daily alcohol consumption for four weeks using SNAPPY-DOC, while those allocated to the control group received no intervention. Outcome measures included the amount of alcohol consumption in past seven days using the Timeline Follow-Back (TLFB) method in SNAPPY-DOC at baseline (Week 0), 8th week (Week 8), and 12th week (Week 12) and written AUDIT score at baseline (Week 0) and 12th week (Week 12). If there was no login to the program at 8th week (Week 8), and 12th week (Week 12), the researcher sent a reminder email to the participant one week later requesting a record. If there was still no response, a further week later, the researcher contacted the participants through the occupational health professionals or other personnel in their respective workplaces to request a record. RESULTS Hundred participants were assigned to either the intervention group (n=50) or the control group (n=50). All the participants logged into the program, and no participants dropped out of the follow-up. The results of two-way repeated measures ANOVA showed a statistically significant interaction between the Group and the Week factors in the two primary outcomes (number of alcohol-free days in the past seven days, total drinks in the past seven days in standard units) and secondary outcomes (AUDIT score) (P=.04, .02, and .03, respectively). The intervention group had reduced alcohol consumption from 329 g to 246 g per week on average at the 12-week evaluation (P<.001), while the control group had reduced from 294 g to 276 g per week on average (P=.83). CONCLUSIONS The web-based BI program for problem drinkers (SNAPPY-DOC program) was considered to be low-cost, effective, and acceptable for implementation in actual workplace settings. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000037698; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042703


2021 ◽  
Author(s):  
Hui-Ling Hsieh ◽  
Chi-Wen Kao ◽  
Shu-Meng Cheng ◽  
Yue-Cune Chang

BACKGROUND Atrial fibrillation (AF) is related to a variety of chronic diseases and life-threatening complications. It is estimated that by 2050, there will be 72 million patients with AF in Asia, of which 2.9 million will have AF-associated stroke. AF has become a major issue for health care systems. OBJECTIVE We aimed to evaluate the effects of a web-based integrated management program on improving coping strategies, medication adherence, and health-related quality of life (HRQoL) in patients with AF, and to detect the effect on decreasing readmission events. METHODS The parallel-group, single-blind, prospective randomized controlled trial recruited patients with AF from a medical center in northern Taiwan and divided them randomly into intervention and control groups. Patients in the intervention group received the web-based integrated management program, whereas those in the control group received usual care. The measurement tools included the Brief Coping Orientation to Problems Experienced (COPE) scale, Medication Adherence Rating Scale (MARS), the three-level version of the EuroQoL five-dimension self-report questionnaire (EQ-5D-3L), and readmission events 2 years after initiating the intervention. Data were collected at 4 instances (baseline, 1 month, 3 months, and 6 months after initiating the intervention), and analyzed with generalized estimating equations (GEEs). RESULTS A total of 231 patients were recruited and allocated into an intervention (n=115) or control (n=116) group. The mean age of participants was 73.08 (SD 11.71) years. Most participants were diagnosed with paroxysmal AF (171/231, 74%), and the most frequent comorbidity was hypertension (162/231, 70.1%). Compared with the control group, the intervention group showed significantly greater improvement in approach coping strategies, medication adherence, and HRQoL at 1, 3, and 6 months (all <i>P</i>&lt;.05). In addition, the intervention group showed significantly fewer readmission events within 2 years (OR 0.406, <i>P</i>=.03), compared with the control group. CONCLUSIONS The web-based integrated management program can significantly improve patients' coping strategy and medication adherence. Therefore, it can empower patients to maintain disease stability, which is a major factor in improving their HRQoL and reducing readmission events within 2 years. CLINICALTRIAL ClinicalTrials.gov NCT04813094; https://clinicaltrials.gov/ct2/show/NCT04813094.


2018 ◽  
Author(s):  
Jiaxi Lin ◽  
Bianca Faust ◽  
David Daniel Ebert ◽  
Lena Krämer ◽  
Harald Baumeister

BACKGROUND Internet- and mobile-based interventions are effective for the treatment of chronic pain. However, little is known about patients’ willingness to engage with these types of interventions and how the uptake of such interventions can be improved. OBJECTIVE The aim of this study was to identify people’s acceptance, uptake, and adherence (primary outcomes) with regard to an internet- and mobile-based intervention for chronic pain and the influence of an information video as an acceptance-facilitating intervention (AFI). METHODS In this randomized controlled trial with a parallel design, we invited 489 individuals with chronic pain to participate in a Web-based survey assessing the acceptance of internet- and mobile-based interventions with the offer to receive an unguided internet- and mobile-based intervention for chronic pain after completion. Two versions of the Web-based survey (with and without AFI) were randomly sent to two groups: one with AFI (n=245) and one without AFI (n=244). Participants who completed the Web-based survey with or without AFI entered the intervention group or the control group, respectively. In the survey, the individuals’ acceptance of pain interventions, measured with a 4-item scale (sum score ranging from 4 to 20), predictors of acceptance, sociodemographic and pain-related variables, and physical and emotional functioning were assessed. Uptake rates (log in to the intervention) and adherence (number of completed modules) to the intervention was assessed 4 months after intervention access. To examine which factors influence acceptance, uptake rate, and adherence in the internet- and mobile-based interventions, we conducted additional exploratory subgroup analyses. RESULTS In total, 57 (intervention group) and 58 (control group) participants in each group completed the survey and were included in the analyses. The groups did not differ with regard to acceptance, uptake rate, or adherence (P=.64, P=.56, P=.75, respectively). Most participants reported moderate (68/115, 59.1%) to high (36/115, 31.3%) acceptance, with 9.6% (11/115) showing low acceptance (intervention group: mean 13.91, SD 3.47; control group: mean 13.61, SD 3.50). Further, 67% (38/57, intervention group) and 62% (36/58, control group) had logged into the intervention. In both groups, an average of 1.04 (SD 1.51) and 1.14 (SD 1.90) modules were completed, respectively. CONCLUSIONS The informational video was not effective with regard to acceptance, uptake rate, or adherence. Despite the high acceptance, the uptake rate was only moderate and adherence was remarkably low. This study shows that acceptance can be much higher in a sample participating in an internet- and mobile-based intervention efficacy trial than in the target population in routine health care settings. Thus, future research should focus not only on acceptance and uptake facilitating interventions but also on ways to influence adherence. Further research should be conducted within routine health care settings with more representative samples of the target population. CLINICALTRIAL German Clinical Trial Registration DRKS00006183; http://www.drks.de/drks_web/navigate.do ?navigationId=trial.HTML&TRIAL_ID=DRKS00006183 (Archived by WebCite at http://www.webcitation.org/70ebHDhne)


10.2196/13655 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e13655 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  

Background We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. Objective The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. Methods Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). Results At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. Conclusions Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. Trial Registration ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.


2019 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  

BACKGROUND We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. OBJECTIVE The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. METHODS Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). RESULTS At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (<italic>d</italic>=0.58) and anxiety (<italic>d</italic>=0.46) as well as a better quality of life (<italic>d</italic>=0.43) and self-esteem (<italic>d</italic>=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. CONCLUSIONS Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. CLINICALTRIAL ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.


2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert

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)


2020 ◽  
Author(s):  
José Côté ◽  
Geneviève Rouleau ◽  
Maria Pilar Ramirez-Garcia ◽  
Patricia Auger ◽  
Réjean Thomas ◽  
...  

BACKGROUND Taking antiretroviral therapy (ART) is part of the daily life of people living with HIV. Different electronic health (eHealth) initiatives adjunctive to usual care have been proposed to support optimal medication adherence. A web-based intervention called HIV Treatment, Virtual Nursing Assistance, and Education or VIH-TAVIE (from its French version Virus de l’immunodéficience humaine-Traitement assistance virtuelle infirmière et enseignement) was developed to empower people living with HIV to manage their ART and symptoms optimally. OBJECTIVE We aimed to evaluate the effectiveness of VIH-TAVIE in a web-based randomized controlled trial (RCT). METHODS This RCT was entirely web-based, including recruitment, consent granting, questionnaire completion, and intervention exposure (consultation with VIH-TAVIE [experimental group] or websites [control group]). To be eligible for the study, people living with HIV had to be 18 years or older, be on ART for at least 6 months, have internet access, and have internet literacy. Participants were randomly assigned to either the experimental group (n=45) or control group (n=43). The primary outcome was ART adherence. The secondary outcomes included self-efficacy regarding medication intake, symptom-related discomfort, skills and strategies, and social support. All outcomes were measured with a self-administered web-based questionnaire at the following three time points: baseline and 3 and 6 months later. A generalized linear mixed model was built to assess the evolution of ART adherence over time in both groups. RESULTS The sample included 88 participants, and of these, 73 (83%) were men. The median age of the participants was 42 years. Participants had been diagnosed with HIV a median of 7 years earlier (IQR 3-17) and had been on ART for a median of 5 years (IQR 2-12). The proportion of treatment-adherent participants at baseline was high in both groups (34/41, 83% in the experimental group and 30/39, 77% in the control group). Participants also reported high treatment adherence, high self-efficacy, and high skills; perceived good social support; and experienced low discomfort from symptoms. Analyses revealed no intergroup difference regarding ART adherence (OR 1.9, 95% CI 0.6-6.4). CONCLUSIONS This study highlights the challenges and lessons learned from conducting an entirely web-based RCT among people living with HIV. The challenges were related to the engagement of people living with HIV on the following three levels: starting the web-based study (recruitment), completing the web-based intervention (engagement), and continuing the study (retention). The results contribute to the existing body of knowledge regarding how to conduct web-based evaluation studies of eHealth interventions aimed at developing and strengthening personal skills and abilities. CLINICALTRIAL ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340


2021 ◽  
pp. 105477382110176
Author(s):  
Esmail Shariati ◽  
Ali Dadgari ◽  
Seyedeh Solmaz Talebi ◽  
Gholam Reza Mahmoodi Shan ◽  
Hossein Ebrahimi

The aim of this study was to identify the effect of web-based communication between a nurse and a family member of a patient with COVID-19 on his/her perceived stress. In this multicenter parallel randomized controlled trial, 67 family members of COVID-19 patients admitted to the Intensive Care Unit (ICU) were investigated. In the intervention group, web-based communication was performed for four consecutive days for 10 to 15 minutes. The Perceived Stress Scale (PSS-14) were completed in both groups before and after the intervention. Mean and standard deviation of perceived stress scores in the two groups were not significantly different ( p = 0.26) before the intervention; however, after the intervention, the mean PSS-14 in the intervention group was significantly lower than that of the control group ( p < 0.001). Due to the need to follow the physical and social distancing to protect against Coronavirus disease, the use of web-based communication recommended in future studies.


2017 ◽  
Author(s):  
Ulrika Müssener ◽  
Kristin Thomas ◽  
Catharina Linderoth ◽  
Matti Leijon ◽  
Marcus Bendtsen

BACKGROUND Heavy consumption of alcohol among university students is a global problem, with excessive drinking being the social norm. Students can be a difficult target group to reach, and only a minority seek alcohol-related support. It is important to develop interventions that can reach university students in a way that does not further stretch the resources of the health services. Text messaging (short message service, SMS)–based interventions can enable continuous, real-time, cost-effective, brief support in a real-world setting, but there is a limited amount of evidence for effective interventions on alcohol consumption among young people based on text messaging. To address this, a text messaging–based alcohol consumption intervention, the Amadeus 3 intervention, was developed. OBJECTIVE This study explored self-reported changes in drinking habits in an intervention group and a control group. Additionally, user satisfaction among the intervention group and the experience of being allocated to a control group were explored. METHODS Students allocated to the intervention group (n=460) were asked about their drinking habits and offered the opportunity to give their opinion on the structure and content of the intervention. Students in the control group (n=436) were asked about their drinking habits and their experience in being allocated to the control group. Participants received an email containing an electronic link to a short questionnaire. Descriptive analyses of the distribution of the responses to the 12 questions for the intervention group and 5 questions for the control group were performed. RESULTS The response rate for the user feedback questionnaire of the intervention group was 38% (176/460) and of the control group was 30% (129/436). The variation in the content of the text messages from facts to motivational and practical advice was appreciated by 77% (135/176) participants, and 55% (97/176) found the number of messages per week to be adequate. Overall, 81% (142/176) participants stated that they had read all or nearly all the messages, and 52% (91/176) participants stated that they were drinking less, and increased awareness regarding negative consequences was expressed as the main reason for reduced alcohol consumption. Among the participants in the control group, 40% (52/129) stated that it did not matter that they had to wait for access to the intervention. Regarding actions taken while waiting for access, 48% (62/129) participants claimed that they continued to drink as before, whereas 35% (45/129) tried to reduce their consumption without any support. CONCLUSIONS Although the main randomized controlled trial was not able to detect a statistically significant effect of the intervention, most participants in this qualitative follow-up study stated that participation in the study helped them reflect upon their consumption, leading to altered drinking habits and reduced alcohol consumption. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN95054707; http://www.isrctn.com/ISRCTN95054707 (Archived by WebCite at http://www.webcitation.org/705putNZT)


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