scholarly journals A Web-Based Intervention for Users of Amphetamine-Type Stimulants: 3-Month Outcomes of a Randomized Controlled Trial

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).

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


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


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)


2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.


JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434


2021 ◽  
Author(s):  
Mohammad Habibur Rahman Sarker ◽  
Michiko Moriyama ◽  
Harun Ur Rashid ◽  
Md Moshiur Rahman ◽  
Mohammod Jobayer Chisti ◽  
...  

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191


2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Anouk S. Schuit ◽  
Karen Holtmaat ◽  
Nienke Hooghiemstra ◽  
Femke Jansen ◽  
Birgit I. Lissenberg-Witte ◽  
...  

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.


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.


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


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