Does an Explicit Value Clarification Method with Computer-Tailored Advice Increase the Effectiveness of a Web-based Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance? Findings From a Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Thomas Gültzow ◽  
Eline Suzanne Smit ◽  
Rik Crutzen ◽  
Shahab Jolani ◽  
Ciska Hoving ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Control Group ◽  
Evidence Based ◽  
Case Scenario ◽  
Worst Case ◽  
Web Based ◽  
Worst Case Scenario ◽  
Tailored Advice

BACKGROUND Smoking continues to be a driver of mortality. Various forms of evidence-based cessation assistance exist, but their use is limited. The decision between them may also induce decisional conflict. Offering decision aids (DAs) may be beneficial, but insights into their effective elements are lacking. OBJECTIVE To test the added value of an effective element (ie, an 'explicit value clarification method' [VCM] paired with computer-tailored advice) of a web-based DA focusing on cessation assistance. The computer-tailored advice indicated the most fitting cessation assistance. The primary outcome measure was 7-day point prevalence abstinence 6 months post baseline (t=3). Secondary outcome measures were 7-day point prevalence abstinence 1 month post baseline (t=2), evidence-based cessation assistance use (t=2 and t=3), and decisional conflict (immediately post DA, t=1). METHODS A randomized controlled trial (RCT) was conducted. The intervention group received a DA with an explicit VCM with computer-tailored advice, the control group received the same DA without these elements. Participants were mainly recruited online (eg, social media). All data was self-reported. Logistic and linear regression analyses (crude and adjusted for covariates) were performed to assess the outcomes. To test the robustness, analyses were conducted following 2 (decisional conflict) and 3 (smoking cessation outcomes) different scenarios: (1) Complete cases, (2) worst-case scenario (dropout respondents are considered to smoke, smoking outcomes only), and (3) multiple imputations. According to an a priori sample size calculation (α=.05; β=.20), 796 participants were needed. RESULTS 2375 participants were randomized (n = 1164 intervention), 599 participants completed the DAs (n = 275 intervention), 276 (n = 143 intervention), 97 (n = 54 intervention), and 103 (n = 56 intervention) participants completed t=1, t=2 and t=3, respectively. Effects in favor of the intervention group on the primary outcome were only observed in the worst-case scenario (P = .02 [crude]; P = .04 [adjusted]). Effects on the secondary outcomes were only observed regarding smoking abstinence after 1 month (P = .02 in the crude and adjusted model), cessation assistance uptake after 1 months (only in the crude model, P = .04) and after 6 months (P = .01 [crude]; P = .02 [adjusted]), but also only in the worst-case scenario. Non-usage attrition was 34.19% higher in the intervention group than in the control group (P < .001). CONCLUSIONS We cannot confidently recommend the inclusion of explicit VCMs and computer-tailored advice at this point. In fact, they might result in higher attrition rates during DA completion, thereby limiting their potential. However, because a lack of statistical power may influenced our findings regarding the outcomes, we recommend replicating this study, taking our lessons learned into account. For example, we found indications that a stronger emphasis on usage times is justified in relation to digital DAs. CLINICALTRIAL Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 INTERNATIONAL REGISTERED REPORT RR2-10.2196/21772

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

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

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

scholarly journals Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

2017 ◽  
Vol 52 (13) ◽  
pp. 851-858 ◽  
Author(s):  
Luiz Carlos Hespanhol ◽  
Willem van Mechelen ◽  
Evert Verhagen
Keyword(s):  
Randomised Controlled Trial ◽  
Preventive Intervention ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Number Needed To Treat ◽  
Preventive Behaviour ◽  
Randomised Controlled ◽  
Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

scholarly journals Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI): A Pragmatic Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1289-1289
Author(s):  
Hayford Avedzi ◽  
Allison Soprovich ◽  
Stephanie Ramage ◽  
Abdulrhman Alghamdi ◽  
Kate Storey ◽  
...  
Keyword(s):  
Nutrition Education ◽  
Glycemic Index ◽  
Self Efficacy ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dietary Intakes ◽  
Web Based ◽  
Phone Calls

Abstract Objectives Rigorous evidence is needed to support uptake of recommendations to include low glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for people with type 2 diabetes (T2D). We evaluated the effectiveness of a 12-week web-based GI-targeted nutrition education intervention on dietary intakes and GI-related knowledge among adults with T2D. Methods Participants were randomized to a control group (n = 34) that received standard printed copies of Canada's Food Guide and Diabetes Canada's GI resources or an intervention group (n = 33) that received those same materials, plus an online platform with six self-directed learning modules and supplementary print material. Each module consisted of a customized video, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and advice for low-GI shopping, recipes, and cooking tips by a Registered Dietitian. Preferred supports through email, text messaging, phone calls, or postal mail to reinforce participants’ learning were also provided. The primary outcome, average daily dietary GI intake, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin A1c, lipids, systolic blood pressure, body mass index, waist circumference, and computer proficiency, were assessed at baseline and at three months post-intervention. Results Participants (N = 67) were 64% men; mean (standard deviation [SD]) age 69.5 (9.3) years, with mean diabetes duration of 19.0 (13.7) years, BMI 30.1 (5.7) kg/m2 and A1c 7.1 (1.2)% at baseline. Mean daily GI intake decreased in the intervention group by 2.79 (7.77) compared to a 0.76 (6.48) increase in the control group (adjusted mean difference [95% CI]; −3.77 [−6.95, −0.58]). Mean GI knowledge 2.14 [0.59, 3.69], understanding of GI concept 1.65 [0.85, 2.44] and self-efficacy for consuming low-GI foods 1.29 [0.51, 2.07] increased among the intervention group (P &lt; 0.01) compared with the control group. Conclusions Web-based GI-targeted education program improved the quality of carbohydrate consumption among adults with T2D and may have been mediated through increases in knowledge and self-efficacy. Web-based nutrition education may be an effective alternative in this population. Funding Sources Canadian Foundation for Dietetic Research.

scholarly journals Web-based stress management for newly diagnosed cancer patients (STREAM): A randomized, wait-list controlled intervention study.

2017 ◽  
Vol 35 (18_suppl) ◽  
pp. LBA10002-LBA10002 ◽  
Author(s):  
Viviane Hess ◽  
Astrid Grossert ◽  
Judith Alder ◽  
Sandra Scherer ◽  
Barbara Handschin ◽  
...  
Keyword(s):  
Stress Management ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Intervention Group ◽  
Management Program ◽  
Control Group ◽  
Wait List ◽  
Newly Diagnosed ◽  
Web Based ◽  
Minimal Contact

LBA10002 Background: Being diagnosed with cancer causes major distress, yet the majority of newly diagnosed cancer patients (pts) lack psychological support. Internet interventions overcome many barriers for seeking support. We assess efficacy and feasibility of a web-based minimal-contact stress management intervention (STREAM) for newly diagnosed cancer pts. Methods: In a prospective, wait-list controlled trial, newly diagnosed cancer pts were randomized within 12 weeks of starting anti-cancer treatment to an immediate or delayed (control group) 8-week, web-based intervention. The intervention consisted of 8 modules with weekly written feedback by a psychologist (“minimal-contact”) based on well-established stress management manuals. The aim of this study was to evaluate efficacy in terms of improvement in QoL (FACIT-F), decrease in distress (DT), anxiety/depression (HADS), as compared to pts in the wait-list group. 120 pts were needed to show (80% power, 2-sided α of 0.05) a clinically meaningful difference of ≥ 9 in FACT score after the immediate intervention (week 8 = T2). Results: 225 pts applied online. 128 pts were randomized. Median age was 52 (22-77)y. 108 (84%) were female. The majority of pts were treated in the curative setting (117pts; 91%), with chemotherapy (74 pts; 58%), for breast cancer (91pts; 71%). Self-reported distress at baseline ( = stratification factor) was above 4 on a 10-point scale (DT) with 96 pts (75%). At T2, QoL (FACIT-F) was sign. increased (p = 0.044; ANCOVA adjusted for baseline-distress) and distress sign. lowered (p = 0.032) in the intervention group as compared to the wait-list control. Median score (lower/upper quartile) for FACIT-F at baseline/T2 was 101.0(80.8/120)/119.0(98.0/132) and 108.3(87.8/124.0) /109.5(97.2/121.0); of DT at baseline/T2 was 6(5/8)/4(3/6) and 6(5/8)/6(4/7) for the intervention and control group, respectively. Decrease in HADS was not sign. different between the groups (p = 0.273). Conclusions: With STREAM, we open the field of minimal-contact online interventions to newly diagnosed cancer pts and show that an 8-week web-based stress management program is feasible and effective in improving QoL and distress. Clinical trial information: NCT02289014.

scholarly journals The Impact of Implementing Steps of Empowerment Model on Decisional Conflict for Re-Pregnancy for Women with Failed Pregnancies: A Randomized Controlled Trial

2021 ◽  
Vol 15 (5) ◽  
pp. 1604-1615
Author(s):  
Mozhgan Zareyee Salehabadi ◽  
Masoomeh Kheirkhah ◽  
Nazanin Esmaeeli ◽  
Shima Haghani
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Control Group ◽  
Random Allocation ◽  
Decision Conflict ◽  
Randomized Controlled ◽  
Empowerment Model ◽  
The Impact

Background: Failed pregnancy is known as a common and destructive experience. It has physical and psychological effects on both women and their families. Due to this experience, they may become reluctant to be pregnant again. In this regard, providing the coping strategies can help in being adapted to failed pregnancies, and making informed decisions on future pregnancies. So, this study was designed and then performed to determine the effect of implementing steps of empowerment model on decision conflict for re-pregnancy for women with failed pregnancies Method: This interventional research was a randomized controlled trial with a control group conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during the past 3-6 weeks due to failed pregnancies. Afterward, the eligible women were divided into the two groups of intervention (n=40) and control (n=40) with random allocation of sealed envelope site and a separate code was then determined for each person. The intervention was performed in four sessions lasted for 90-minute based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed in both groups once before and once six weeks after intervention. The obtained data were analyzed using SPSS edition 16 with the independent T-test, Fisher, and chi-squared tests. Results The scores of decisional conflict and its subscales had no differences between the two groups before the intervention (P = 0.65). However, by passing six weeks from the intervention, the decisional conflict and all its subscales have reduced in the intervention group. (P < 0.001). Conclusion: Empowerment education in women with failed pregnancies improved their decision conflict in immune re-pregnancy, so empowerment education along with health care services is recommended for women with failed pregnancies. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019. https://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5336 Keywords: Empowerment, Conflict, Decision Making, Failed Pregnancy.

scholarly journals Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients with Aphasia: Protocol for a Virtual Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Esther Kim ◽  
Laura Laird ◽  
Carlee Wilson ◽  
Till Bieg ◽  
Phillip Mildner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Lexical Retrieval ◽  
Evidence Based ◽  
Waitlist Control ◽  
Treatment Assessment ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mobile application-based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia (PwA) as an adjunct or in lieu of traditional in-person therapy approaches. These apps can increase the intensity of treatment, and have been shown to result in meaningful outcomes across several domains OBJECTIVE VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to engage PwA to improve their naming abilities through interaction with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia. METHODS A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. Intervention group participants will engage in five weeks of training with the app, followed by post-treatment assessment and follow-up assessment after an additional five weeks. Those in the waitlist control group will have five weeks of no training, followed by a pre-treatment assessment, training for five weeks and post-treatment assessment. All aspects of the trial are being conducted remotely given the COVID-19 pandemic. RESULTS Recruitment of participants started in September 2020 and the study is expected to be completed by March 2022. Publication of results is expected within six months of study completion. CONCLUSIONS Results of the RCT will provide data to inform evidence-based practice on the use of technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in PwA within an easily accessible, cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can inform the profession on telerehabilitation practices and monitoring app-based home therapy programs. CLINICALTRIAL ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364

scholarly journals Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial

2019 ◽  
Vol 25 (3) ◽  
pp. 102-108
Author(s):  
Mengyang Di ◽  
Chen Mao ◽  
Zuyao Yang ◽  
Hong Ding ◽  
Qu Liu ◽  
...  
Keyword(s):  
Mild Hypertension ◽  
Antihypertensive Drugs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Medication Use ◽  
Control Group ◽  
Evidence Based ◽  
Randomised Controlled ◽  
Insured Patients

ObjectiveTo evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.MethodsWe conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.ResultsTwo hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.ConclusionsThe EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.Trial registration numberChiCTR-TRC-14004169.

scholarly journals The Effect of the Web-Based Communication between a Nurse and a Family Member on the Perceived Stress of the Family Member of Patients with Suspected or Confirmed COVID-19: A Parallel Randomized Clinical Trial

2021 ◽  
pp. 105477382110176
Author(s):  
Esmail Shariati ◽  
Ali Dadgari ◽  
Seyedeh Solmaz Talebi ◽  
Gholam Reza Mahmoodi Shan ◽  
Hossein Ebrahimi
Keyword(s):  
Family Member ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled ◽  
The Family ◽  
Before And After ◽  
The Mean

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.

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

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

scholarly journals Expert-based medication reviews to reduce polypharmacy in older patients in primary care: a northern-Italian cluster-randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Angelika Mahlknecht ◽  
Christian J. Wiedermann ◽  
Marco Sandri ◽  
Adolf Engl ◽  
Martina Valentini ◽  
...  
Keyword(s):  
Older Patients ◽  
Primary Outcome ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Evidence Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background Evidence regarding clinically relevant effects of interventions aiming at reducing polypharmacy is weak, especially for the primary care setting. This study was initiated with the objective to achieve clinical benefits for older patients (aged 75+) by means of evidence-based reduction of polypharmacy (defined as ≥8 prescribed drugs) and inappropriate prescribing in general practice. Methods The cluster-randomised controlled trial involved general practitioners and patients in a northern-Italian region. The intervention consisted of a review of patient’s medication regimens by three experts who gave specific recommendations for drug discontinuation. Main outcome measures were non-elective hospital admissions or death within 24 months (composite primary endpoint). Secondary outcomes were drug numbers, hospital admissions, mortality, falls, fractures, quality of life, affective status, cognitive function. Results Twenty-two GPs/307 patients participated in the intervention group, 21 GPs/272 patients in the control group. One hundred twenty-five patients (40.7%) experienced the primary outcome in the intervention group, 87 patients (32.0%) in the control group. The adjusted rates of occurrence of the primary outcome did not differ significantly between the study groups (intention-to-treat analysis: adjusted odds ratio 1.46, 95%CI 0.99–2.18, p = 0.06; per-protocol analysis: adjusted OR 1.33, 95%CI 0.87–2.04, p = 0.2). Hospitalisations as single endpoint occurred more frequently in the intervention group according to the unadjusted analysis (OR 1.61, 95%CI 1.03–2.51, p = 0.04) but not in the adjusted analysis (OR 1.39, 95%CI 0.95–2.03, p = 0.09). Falls occurred less frequently in the intervention group (adjusted OR 0.55, 95%CI 0.31–0.98; p = 0.04). No significant differences were found regarding the other outcomes. Definitive discontinuation was obtained for 67 (16.0%) of 419 drugs rated as inappropriate. About 6% of the prescribed drugs were PIMs. Conclusions No conclusive effects were found regarding mortality and non-elective hospitalisations as composite respectively single endpoints. Falls were significantly reduced in the intervention group, although definitive discontinuation was achieved for only one out of six inappropriate drugs. These results indicate that (1) even a modest reduction of inappropriate medications may entail positive clinical effects, and that (2) focusing on evidence-based new drug prescriptions and prevention of polypharmacy may be more effective than deprescribing. Trial registration Current Controlled Trials (ID ISRCTN: 38449870), date: 11/09/2013.

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