scholarly journals Effectiveness of a Web-Based Intervention to Support Medication Adherence Among People Living With HIV: Web-Based Randomized Controlled Trial (Preprint)

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

10.2196/17733 ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e17733
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. Trial Registration ClinicalTrials.gov NCT01510340; https://clinicaltrials.gov/ct2/show/NCT01510340


2021 ◽  
Author(s):  
José Côté ◽  
Sylvie Cossette ◽  
Pilar Ramirez-Garcia ◽  
Alexandra De Pokomandy ◽  
Catherine Worthington ◽  
...  

Background Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours. Methods/Design An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ≥ 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n = 375) or to a control group (websites, n = 375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis. Discussion This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors.


2021 ◽  
Author(s):  
José Côté ◽  
Sylvie Cossette ◽  
Pilar Ramirez-Garcia ◽  
Alexandra De Pokomandy ◽  
Catherine Worthington ◽  
...  

Background Long-term use of antiretroviral therapy, normal aging, and presence of certain risk factors are associated with metabolic disorders that predispose persons living with HIV to diabetes and cardiovascular diseases. The emergence and progression of these disorders can be prevented by adopting healthy behaviours. Based on the theory of planned behaviour, the Web-based tailored intervention TAVIE en santé was developed. The aim of this study is to evaluate the effectiveness of TAVIE en santé in order to support people living with HIV in the adoption of health promoting behaviours. Methods/Design An online randomized controlled trial with parallel-groups will be conducted across Canada. To participate in this study, people living with HIV must be: ≥ 18 years, able to read/understand French or English, have access to the Internet. A convenience sample of 750 participants will be randomly assigned either to an experimental group (TAVIE en santé, n = 375) or to a control group (websites, n = 375) (1:1 allocation ratio). The TAVIE en santé intervention is composed of seven interactive computer sessions, lasting between 5 and 10 min. The sessions, hosted by a virtual nurse, aim to develop and strengthen skills required for behaviour change. The control group will receive a validated list of five predetermined conventional health-related Websites. The adoption of health behaviour (smoking cessation or physical activity or healthy eating) is the principal outcome. Cognitions (intention, attitude, perceived behavioral control) are the secondary outcomes. Health indicators will also be assessed. All outcomes will be measured with a self-administered online questionnaire and collected three times: at baseline, 3 and 6 months after. The principal analyses will focus on differences between the two trial groups using Intention-to-Treat analysis. Discussion This study will yield new results about the efficacy of Web-based tailored health behaviours change interventions in the context of chronic disease. The TAVIE en santé intervention could constitute an accessible complementary service in support of existing specialized services to support people living with HIV adopt health behaviors.


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


10.2196/15702 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e15702
Author(s):  
Yan Pang ◽  
James Steven Molton ◽  
Wei Tsang Ooi ◽  
Nicholas Iain Paton ◽  
Hong-Gu He

Background As people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission. Objective This study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore. Methods We conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device—Medication Event Monitoring System (MEMS)—and a mobile app—MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention. Results All participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results. Conclusions Although MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app–assisted intervention RCTs in the future. Trial Registration ClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648


2018 ◽  
Author(s):  
Burçin Ünlü Ince ◽  
Didem Gökçay ◽  
Heleen Riper ◽  
Pim Cuijpers

BACKGROUND In Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey. OBJECTIVE This study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey. METHODS Participants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her Şey Kontrol Altında (HŞKA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline). RESULTS We will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1). CONCLUSIONS Results from this study will reveal more information about the clinical effects of HŞKA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms. CLINICALTRIAL ClinicalTrials.gov NCT03754829; https://clinicaltrials.gov/ct2/show/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7). INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13239


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)


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