scholarly journals A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Andrew H Kim ◽  
Afaf Girgis ◽  
Neda Karimi ◽  
Alexandra J Sechi ◽  
Joseph Descallar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Decision Making ◽  
Decision Aid ◽  
Controlled Trial ◽  
Treatment Decisions ◽  
Web Based ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. OBJECTIVE This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. METHODS The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). RESULTS Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. CONCLUSIONS myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15994

scholarly journals A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial

10.2196/15994 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e15994
Author(s):  
Andrew H Kim ◽  
Afaf Girgis ◽  
Neda Karimi ◽  
Alexandra J Sechi ◽  
Joseph Descallar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Decision Making ◽  
Decision Aid ◽  
Controlled Trial ◽  
Treatment Decisions ◽  
Web Based ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. Objective This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. Methods The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). Results Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. Conclusions myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370 International Registered Report Identifier (IRRID) DERR1-10.2196/15994

scholarly journals A tablet-based intervention for activating nursing home residents with dementia: results from a cluster-randomized controlled trial

2021 ◽  
pp. 1-13
Author(s):  
Julie L. O’Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Nursing Homes ◽  
Psychotropic Medication ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Objectives: To investigate global and momentary effects of a tablet-based non-pharmacological intervention for nursing home residents living with dementia. Design: Cluster-randomized controlled trial. Setting: Ten nursing homes in Germany were randomly allocated to the tablet-based intervention (TBI, 5 units) or conventional activity sessions (CAS, 5 units). Participants: N = 162 residents with dementia. Intervention: Participants received regular TBI (n = 80) with stimulating activities developed to engage people with dementia or CAS (n = 82) for 8 weeks. Measurements: Apathy Evaluation Scale (AES-I, primary outcome), Quality of Life in Alzheimer’s Disease scale, QUALIDEM scale, Neuropsychiatric Inventory, Geriatric Depression Scale, and psychotropic medication (secondary outcomes). Momentary quality of life was assessed before and after each activity session. Participants and staff were blinded until the collection of baseline data was completed. Data were analyzed with linear mixed-effects models. Results: Levels of apathy decreased slightly in both groups (mean decrease in AES-I of .61 points, 95% CI −3.54, 2.33 for TBI and .36 points, 95% CI −3.27, 2.55 for CAS). Group difference in change of apathy was not statistically significant (β = .25; 95% CI 3.89, 4.38, p = .91). This corresponds to a standardized effect size (Cohen’s d) of .02. A reduction of psychotropic medication was found for TBI compared to CAS. Further analyses revealed a post-intervention improvement in QUALIDEM scores across both groups and short-term improvements of momentary quality of life in the CAS group. Conclusions: Our findings suggest that interventions involving tailored activities have a beneficial impact on global and momentary quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, tablet computers can support delivery of non-pharmacological interventions in nursing homes and facilitate regular assessments of fluctuating momentary states.

scholarly journals Evaluation of a Brief Intervention for Promoting Mental Health among Employees in Social Enterprises: A Cluster Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2107 ◽  
Author(s):  
Benedicte Deforche ◽  
Jasmine Mommen ◽  
Anne Hublet ◽  
Winnie De Roover ◽  
Nele Huys ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Social Enterprises ◽  
Randomized Controlled ◽  
Cluster Randomized

Evidence on the effectiveness of workplace mental health promotion for people with disabilities is limited. This study aimed to evaluate the effectiveness of a brief mental health promotion intervention in social enterprises. It had a non-blinded cluster randomized controlled trial design with follow-up one and four months after the intervention. In total 196 employees agreed to participate (86 intervention and 110 control). Empowerment was the main outcome; secondary outcomes were resilience, palliative behavior, determinants of four coping strategies of mental health, quality of life, and life satisfaction. A brief participant satisfaction survey was conducted after the intervention. No significant intervention effect on empowerment was found. However, at one month follow-up, significant favorable effects were found on perceived social support for coping strategies for mental health and on palliative behavior. At four months follow-up, favorable intervention effects were found on quality of life, but unfavorable effects were found on unjustified worrying. In addition, the intervention was well received by the employees. This brief intervention might be a promising first step to improve mental health in people with disabilities working in social enterprises. Nevertheless, additional monitoring by professionals and managers working in the organizations might be needed to maintain these effects.

scholarly journals Efficacy of a Web-Enabled, School-Based, Preventative Intervention to Reduce Bullying and Improve Mental Health in Children and Adolescents: Study Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Bullying Victimization ◽  
Randomized Controlled ◽  
School Based ◽  
Cluster Randomized

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.

Web-Based Intervention to Improve Implantable Cardioverter Defibrillator Patients’ Shock-Related Anxiety and Quality of Life: A Randomized Controlled Trial

2017 ◽  
Vol 28 (2) ◽  
pp. 150-164 ◽  
Author(s):  
Tuğba Yardımcı ◽  
Hatice Mert
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Implantable Cardioverter Defibrillator ◽  
Controlled Trial ◽  
Web Based ◽  
Cardioverter Defibrillator ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Shock Anxiety

In spite of its effectiveness, implantable cardioverter defibrillator (ICD) patients face psychological problems such as shock-related anxiety due to device shocks. The aim of this study was to evaluate whether a web-based intervention program for ICD patients would reduce shock-related anxiety and improve quality of life compared with usual care. This was a randomized controlled trial study including a total of 76 patients. Data were collected using Turkish versions of the Florida Shock Anxiety Scale and Short Form Health Survey (SF-36) at 0 (baseline), 3, and 6 months. Following intervention, there was a significant decrease in shock anxiety levels of patients and a statistically significant increase in social functioning, role-physical, mental health, vitality, and bodily pain subdimensions of SF-36. While no statistically significant difference was found between groups in terms of summary scores of SF-36, our results suggest that web-based interventions can be useful for ICD patients.

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