scholarly journals A Web-Based Integrated Management Program for Improving Medication Adherence and Quality of Life, and Reducing Readmission in Patients With Atrial Fibrillation: Randomized Controlled Trial (Preprint)

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.

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):  
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


2014 ◽  
Vol 1 (1) ◽  
pp. e1 ◽  
Author(s):  
Robert J Tait ◽  
Rebecca McKetin ◽  
Frances Kay-Lambkin ◽  
Bradley Carron-Arthur ◽  
Anthony Bennett ◽  
...  

Background Among illicit drugs, the prevalence of amphetamine-type stimulant (ATS) use is second only to cannabis. Currently, there are no approved pharmacotherapies for ATS problems, but some face-to-face psychotherapies are effective. Web-based interventions have proven to be effective for some substance use problems, but none has specifically targeted ATS users. Objective The objective of the study was to evaluate the effectiveness of a Web-based intervention for ATS problems on a free-to-access site compared with a waitlist control group. Methods We used a randomized controlled trial design. The primary outcome measure was self-reported ATS use in the past three months assessed using the Alcohol, Smoking, Substance Involvement Screening Test (ASSIST). Other measures included quality of life (EUROHIS score), psychological distress (K-10 score), days out of role, poly-drug use, general help-seeking intentions, actual help-seeking, and “readiness to change”. The intervention consisted of three fully automated, self-guided modules based on cognitive behavioral therapy and motivation enhancement. The analysis was an intention-to-treat analysis using generalized estimating equation models, with a group by time interaction as the critical assessment. Results We randomized 160 people (intervention n=81, control n=79). At three months, 35/81 (43%) intervention and 45/79 (57%) control participants provided follow-up data. In the intervention group, 51/81 (63%) completed at least one module. The only significant group by time interaction was for days out of role. The pre/post change effect sizes showed small changes (range d=0.14 to 0.40) favoring the intervention group for poly-drug use, distress, actual help-seeking, and days out of role. In contrast, the control group was favored by reductions in ATS use, improvements in quality of life, and increases in help-seeking intentions (range d=0.09 to 0.16). Conclusions This Web-based intervention for ATS use produced few significant changes in outcome measures. There were moderate, but nonsignificant reductions in poly-drug use, distress, days partially out of role, and increases in help-seeking. However, high levels of participant attrition, plus low levels of engagement with the modules, preclude firm conclusions being drawn on the efficacy of the intervention and emphasize the problems of engaging this group of clients in a fully automated program. Trial Registration Australian and New Zealand Clinical Trials Registry: ACTRN 12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000947909 (Archived by WebCite at http://www.webcitation.org/6SHTxEnzP).


10.2196/15001 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e15001
Author(s):  
Sarah MacLean ◽  
Daniel J Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733


2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (<i>The Journal</i>) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t<sub>91</sub>=−0.37; <i>P</i>=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t<sub>84</sub>=−2.73; <i>P</i>=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in <i>The Journal</i> and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in <i>The Journal</i>, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ<sup>2</sup><sub>1</sub>=6.3; <i>P</i>=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733


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


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.


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