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Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol.

ABSTRACT: BACKGROUND:Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE:This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS:ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS:We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS:ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. TRIAL REGISTRATION:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17589.

SUBMITTER: Chung A

PROVIDER: S-EPMC7388047 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol.

Chung Alicia A Seixas Azizi A Williams Natasha N Senathirajah Yalini Y Robbins Rebecca R Newsome Garcia Valerie V Ravenell Joseph J Jean-Louis Girardin G

JMIR research protocols 20200714 7

<h4>Background</h4>Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color.<h4>Objective</h4>This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll i ...[more]

PMID: 32673274

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Project description:Chronic HIV infection commonly affects both cognition and mental health, even with excellent systemic viral control. The causes of compromised brain health are likely to be a multi-factorial combination of HIV-related biological factors, co-morbidities such as aging and cerebrovascular disease, and the erosion of coping skills, physical health, and social supports resulting from the strains of living with a chronic illness.This study aims to provide a better understanding of the relationship between cognitive complaints, depression, and objectively measured cognitive impairment in HIV, and of the key factors, whether biological or personal, which relate to these presentations and to their evolution over time. Characterization of this heterogeneity will permit more focused pathophysiological studies, and allow more targeted interventions. The project makes extensive use of Web-based research and health care delivery tools, aiming to provide cost-effective, "clinic ready" tools to improve brain health in HIV. This project has two overarching aims, reflecting our dual goals of understanding and improving brain health in HIV, focusing on cognitive impairment, its contributors and consequences. The objectives are to contribute evidence for the validity of a brief brain health assessment, to estimate the extent to which HIV-related cognition-relevant clinical factors and patient-centered outcomes inter-relate and evolve over time, allowing identification of the mechanisms underpinning longitudinal change in brain health and to contribute evidence for the feasibility, effectiveness potential, acceptability, and underlying mechanisms of promising interventions for optimizing brain health. We adopt a cohort multiple randomized control trials design. A total of 900 participants will be characterized prospectively over a 27-month period to answer questions about the evolution of outcomes of interest. All participants will be offered basic brain health self-management information. Sub-groups will participate in pilot studies of specific, more intensive interventions to provide pragmatic evidence for feasibility, effectiveness, and comparative effectiveness.This work will provide needed estimates of the burden, heterogeneity, evolution, and mechanisms underlying compromised brain health in HIV, and test a range of promising non-pharmacological interventions. This is an on-going study; the trials nested within this cohort that are currently recruiting participants were registered on 7 October 2015 (Clinicaltrials.gov NCT02571504 and NCT02571595).

Project description:BackgroundPeople of color (POC) who experience race-related stress are at risk of developing mental health problems, including high levels of stress, anxiety, and depression. Mindfulness meditation may be especially well suited to help POC cope, given its emphasis on gaining awareness and acceptance of emotions associated with discriminatory treatment. However, mindfulness meditation rarely reaches POC, and digital approaches could reduce this treatment gap by addressing traditional barriers to care.ObjectiveThis study will test the effectiveness of a self-directed app-based mindfulness meditation program among POC who experience elevated levels of race-related stress. Implementation outcomes such as treatment acceptability, adherence, and satisfaction will be examined.MethodsParticipants (n=80) will be recruited online by posting recruitment materials on social media and sending emails to relevant groups. In-person recruitment will consist of posting flyers in communities with significant POC representation. Eligible participants will be block randomized to either the intervention group (n=40) that will complete a self-directed 4-week mindfulness meditation program or a wait-list control condition (n=40) that will receive access to the app after study completion. All participants will complete measures at baseline, midtreatment, and posttreatment. Primary outcomes include changes in stress, anxiety, and depression, and secondary outcomes constitute changes in mindfulness, self-compassion, rumination, emotion suppression, and experiential avoidance. Exploratory analyses will examine whether changes in the secondary outcomes mediate changes in primary outcomes. Finally, treatment acceptability, adherence, and satisfaction will be examined descriptively.ResultsRecruitment began in October 2021. Data will be analyzed using multilevel modeling, a statistical methodology that accounts for the dependence among repeated observations. Considering attrition issues in self-directed digital interventions and their potential effects on statistical significance and treatment effect sizes, we will examine data using both intention-to-treat and per-protocol analyses.ConclusionsTo our knowledge, this will be the first study to provide data on the effectiveness of a self-directed app-based mindfulness meditation program for POC recruited based on elevated race-related stress, a high-risk population. Similarly, meaningful clinical targets for POC affected by stressors related to race will be examined. Findings will provide important information regarding whether this type of intervention is an acceptable treatment among these marginalized groups.Trial registrationClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113.International registered report identifier (irrid)DERR1-10.2196/35196.

Project description:The objective of Heart Health NOW (HHN) is to determine if primary care practice support-a comprehensive evidence-based quality improvement strategy involving practice facilitation, academic detailing, technology support, and regional learning collaboratives-accelerates widespread dissemination and implementation of evidence-based guidelines for cardiovascular disease (CVD) prevention in small- to medium-sized primary care practices and, additionally, increases practices' capacity to incorporate other evidence-based clinical guidelines in the future.HHN is a stepped wedge, stratified, cluster randomized trial to evaluate the effect of primary care practice support on evidence-based CVD prevention, organizational change process measures, and patient outcomes. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after the start of the intervention. The intervention will be randomized to practices in one of four strata defined by region of the state (east or west) and degree of practice readiness for change. Seventy-five practices in each region with a high degree of readiness will be randomized 1:1:1 in blocks of 3 sometime prior to month 8 to receive the intervention at month 9, 11, or 12. An additional 75 practices within each region that have a low degree of readiness or are recruited later will be randomized 1:1 in blocks of 2 prior to month 13 to receive the intervention at month 14 or 16. The sites will be ordered within each strata based on time of enrollment with the blocking based on this ordering. Evaluation will examine the effect of primary care practice support on (1) practice-level delivery of evidence-based CVD prevention, (2) patient-level health outcomes, (3) practice-level implementation of clinical and organizational changes that support delivery of evidence-based CVD prevention, and (4) practice-level capacity to implement future evidence-based clinical guidelines.Results will indicate whether primary care practice support is an effective strategy for widespread dissemination and implementation of evidence-based clinical guidelines in primary care practices. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.ClinicalTrials.gov NCT02585557.

Project description:BackgroundWeb-based delivered interventions have become an innovative option to treat health problems, like obesity. The aim of this systematic review and network meta-analysis was to analyze the effectiveness of web-based behavioral treatments for adults with overweight and obesity. Web-based interventions and comparison interventions (traditional weight control programs) were classified according to the following feedback characteristics: frequency, personalization, and provider (human versus machine).MethodFrom the initial 1789 studies, 15 were included in this review. A network meta-analysis was conducted to analyze the efficacy of web-based programs with traditional interventions, considering direct and indirect comparisons. The main outcome was the weight loss mean difference (kg) between baseline and post-treatment. Heterogeneity and consistency assumptions were validated to conduct the network meta-analysis.ResultsNetwork meta-analysis showed comparisons between different treatment options. The main results were that Intensive Contact Web-based programs were more effective than wait-list (Mean Difference - 1.86 kg; 95% Confidence Interval: - 3.61, - 0.12). Moreover, Intensive Contact Web-based programs were more effective than the other web-based options and self-help traditional interventions. However, the only significant comparison was Intensive Contact Web-based programs versus Guided Self-Help Web-based programs (Mean Difference - 4.31 kg; 95% Confidence Interval: - 5,22, - 3,41). Intensive Contact Web-based programs were the most effective treatment option according the obtained results, achieving the first place in the ranking provided by the network meta-analysis with 98.5% of probabilities.ConclusionsIntensive Contact Web-based interventions have obtained the first position in the ranking, proving the relevance of frequent, personalized, and professional feedback and their association with a better prognosis for people with overweight and obesity. These results provide relevant information to design more effective treatments for people with overweight and obesity, in a new format especially appropriate for the current situation.

Project description:BACKGROUND:Chronic low back disorders (CLBDs) are a substantial burden on individuals and societies, and impact up to 20% of Canadians. Rural and remote residents are approximately 30% more likely to have CLBDs. Reduced access to appropriate team-based health services, including physical therapy, is a key factor that may magnify the impact of CLBD on pain, physical function, overall quality of life, health-related system costs, and individual costs. OBJECTIVE:The purpose of this project is to evaluate the validity, comparative effectiveness, costs, barriers, and facilitators of an interprofessional management approach for people with CLBDs, delivered via telehealth. METHODS:This project will examine 3 different health care delivery options: (1) in-person nurse practitioner (NP); (2) in-person physical therapist (PT); and (3) a team approach utilizing an NP (in-person) and a PT joining via telehealth. Validity of the telehealth team care model will be explored by comparing the diagnostic categorization and management recommendations arising from participants with CLBD who undergo a team telehealth, in-person NP, and in-person PT assessment. Comparative effectiveness and costs will be examined using a community-based randomized controlled trial in a rural Saskatchewan community with limited PT services. The 3 arms of the trial are: (1) usual care delivered by a local rural NP; (2) a local NP and an urban-based PT joining via telehealth; and (3) face-to-face services by a PT traveling to the community. Patient-reported outcomes of pain, physical function, quality of life, satisfaction, and CLBD care-related costs will be evaluated up to 6 months after the intervention. Patient and provider experiences with the team telehealth approach will be explored through qualitative interviews. RESULTS:The study was funded in July 2013 and the University of Saskatchewan Biomedical Research Ethics Board approved the study in November 2013. Participant recruitment began in September 2014 and data collection was completed in December 2015. Analysis is in progress and results are anticipated in 2017. CONCLUSIONS:CLBD is a widespread public health problem, particularly in rural and remote areas, which requires new innovative approaches to deliver appropriate health care. The results of this project will inform the development of evidence-informed approaches and community-based implementation strategies to improve access to PT services in primary health care settings in other rural and remote underserved areas. Findings might also provide a framework for cost-effective and patient-centered models of service delivery for the management of other chronic conditions. CLINICALTRIAL:ClinicalTrials.gov NCT02225535; https://clinicaltrials.gov/ct2/show/NCT02225535 (Archived by WebCite at http://www.webcitation.org/6lqLTCNF7).

Project description:BACKGROUND:The evaluation of web-based interventions (defined as an intervention that can be downloaded or accessed on the internet through a web browser) in randomized controlled trials (RCTs) has increased over the past two decades. Little is known about how participants' use of the intervention is measured, reported, and analyzed in these studies. OBJECTIVE:This study aimed to review the evaluation of web-based interventions in RCTs, assessing study characteristics and the methods used to record, and adjust for, intervention usage. METHODS:A systematic review of the literature was undertaken to identify all published reports of RCTs that involved a web-based intervention. A random sample of 100 published trials was selected for detailed data extraction. Information on trial characteristics was extracted, including whether web usage data were recorded, and if so, the methods used to gather these data and whether these data were used to inform efficacy analyses. RESULTS:A PubMed search identified 812 trials of web-based interventions published up to the end of 2017 and demonstrated a growing trend over time. Of the 100 studies reviewed, 90 studies collected web usage data, but more than half (49/90, 54%) of these studies did not state the method used for recording web usage. Only four studies attempted to check on the reliability of their web usage data collection methods. A total of 39% (35/90) studies reported patterns or levels of web intervention use, of which 21% (19/90) studies adjusted for intervention use in their outcome analysis, but only two of these used appropriate statistical methods. CONCLUSIONS:Trialists frequently report a measure of web-based intervention usage but do not always report the collection method or provide enough detail on their analysis of web usage. Appropriate statistical methods to account for intervention use are rarely used and are not well reported even in the very few trials in which they are used. The number of trialists who attempt to check on the reliability of their web usage collection methods is extremely low.

Project description:BackgroundAdvances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children's Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annually, as early detection has demonstrated markedly improved outcomes in the diagnosis and treatment of skin cancers. The goal of the present study is to increase rates of skin self-examinations and clinical skin examinations among adult survivors of childhood cancer treated with radiation.Methods/designThis randomized controlled trial uses a 3-group comparative effectiveness design comparing: (1) Patient Activation and Education (PAE) including text messaging, print and web-based tutorials over 12 months; (2) PAE plus physician activation (PAE + MD) adding physician activation/educational materials about survivors' increased skin cancer risk and conducting full-body skin exams; and (3) PAE plus physician activation, plus teledermoscopy (PAE + MD + TD) adding participant receipt of a dermatoscope intended to empower them to photograph suspect moles or lesions for review by the study dermatologist.DiscussionThe current study addresses barriers to screening in this population by providing educational and motivational information for both survivors and physicians regarding the value of periodic skin examinations. It also utilizes innovative mobile health technology to encourage and motivate (that is activate) survivors to conduct skin self-examinations, request physician exams, and obtain treatment when worrisome lesions are found. Finally, as a comparative effectiveness trial, this study isolates the effects of adding specific components to the patient activation intervention to test the most effective intervention for enhancing skin examination vigilance among this high-risk group.Trial registrationClinicaltrials.gov: NCT02046811 ; Registration date: 22 January 2014.

Project description:BackgroundThe lack of availability of evidence-based services for people exposed to adversity globally has led to the development of psychological interventions with features that will likely make them more scalable. The evidence for the efficacy of e-mental health from high-income countries is compelling, and the use of these interventions could be a way to increase the coverage of evidence-based psychological interventions in low- and middle-income countries. Step-by-Step is a brief (5-session) intervention proposed by the World Health Organization as an innovative approach to reducing the suffering and disability associated with depression.ObjectiveThis study aims to evaluate the effectiveness and cost-effectiveness of a locally adapted version of Step-by-Step with Syrian nationals (trial 1) and Lebanese nationals and other populations residing in Lebanon (trial 2).MethodsThis Step-by-Step trial involves 2 parallel, two-armed, randomized controlled trials comparing the e-intervention Step-by-Step to enhanced care as usual in participants with depressive symptoms and impaired functioning. The randomized controlled trials are designed and powered to detect effectiveness in 2 populations: Syrians in Lebanon (n=568) and other people residing in Lebanon (n=568; Lebanese nationals and other populations resident in Lebanon). The primary outcomes are depressive symptomatology (measured with the Patient Health Questionnaire-9) and functioning (measured with the World Health Organization Disability Assessment Scale 2.0). Secondary outcomes include anxiety symptoms, posttraumatic stress disorder symptoms, personalized measures of psychosocial problems, subjective well-being, and economic effectiveness. Participants are mainly recruited through online advertising. Additional outreach methods will be used if required, for example through dissemination of information through partner agencies and organizations. They can access the intervention on a computer, tablet, and mobile phone through a hybrid app. Step-by-Step has 5 sessions, and users are guided by trained nonspecialist "e-helpers" providing phone-based or message-based support for around 15 minutes a week.ResultsThe trials were funded in 2018. The study protocol was last verified June 20, 2019 (WHO ERC.0002797) and registered with ClinicalTrials.gov (NCT03720769). The trials started recruitment as of December 9, 2019, and all data collection was completed in December 2020.ConclusionsThe Step-by-Step trials will provide evidence about the effectiveness of an e-mental health intervention in Lebanon. If the intervention proves to be effective, this will inform future scale-up of this and similar interventions in Lebanon and in other settings across the world.Trial registrationClinicalTrials.gov NCT03720769; https://clinicaltrials.gov/ct2/show/NCT03720769.International registered report identifier (irrid)DERR1-10.2196/21585.

Project description:BackgroundYoung Australians (16-25 years) have the highest rates of past-month cannabis use in the world. Cannabis use increases the risk of alcohol and other drug disorders and depressive disorders, and has a robust dose-response association with psychotic experiences (PEs) and disorders. PEs are subthreshold positive psychotic symptoms, including delusions and hallucinations, which increase the risk of substance use, depressive or anxiety disorders, and psychotic disorders. Access to effective web-based early interventions targeting both cannabis use and PEs could reduce such risk in young people.ObjectiveThe objective of this study is to determine the efficacy and cost-effectiveness of the Keep it Real web-based program compared to an information-only control website among young cannabis users (16-25 years) with PEs.MethodsParticipants are recruited online, and consenting individuals meeting inclusion criteria (aged 16-25 years, who have used cannabis in the past month and experienced PEs in the past 3 months) are automatically randomized to either the Keep it Real web-based program (n=249) or an information-only control website (n=249). Both websites are self-guided (fully automated). The baseline and follow-up assessments at 3, 6, 9, and 12 months are self-completed online. Primary outcome measures are weekly cannabis use, PEs, and the relative cost-effectiveness for quality-adjusted life years. Secondary outcomes include other substance use and related problems, PE-related distress, cannabis intoxication experiences, severity of cannabis dependence, depression/anxiety symptoms, suicidality, and mental well-being and functioning.ResultsRecruitment commenced in February 2019, and the results are expected to be submitted for publication in mid-2021.ConclusionsThis study protocol describes a large randomized controlled trial of a new web-based program for young cannabis users experiencing PEs. If effective, the accessibility and scalability of Keep it Real could help reduce growing public health concerns about the significant social, economic, and health impacts of cannabis use.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001107213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374800.International registered report identifier (irrid)DERR1-10.2196/15803.

Project description:BackgroundInformal carers play a significant role in supporting people living with dementia; however, carers in rural areas are often isolated, with limited access to support services. Although dementia-friendly communities provide valued support for carers, access to them is limited as they are few and geographically dispersed.ObjectiveThis study's aim was to increase support and services for rural informal carers of people living with dementia by using information and communication technologies accessed through an integrated website and mobile app-the Verily Connect app. The objective of this protocol is to detail the research design used in a complex study that was situated in a challenging real-world setting integrating web-based and on-ground technology and communication. Therefore, it is anticipated that this protocol will strengthen the research of others exploring similar complex concepts.MethodsA stepped-wedge, open-cohort cluster randomized controlled trial was conducted to implement Verily Connect across 12 rural Australian communities. The Verily Connect intervention delivered web-based, curated information about dementia, a localized directory of dementia services and support, group and individual chat forums, and peer support through videoconference. During the implementation phase of 32 weeks, Verily Connect was progressively implemented in four 8-weekly waves of 3 communities per wave. Usual care, used as a comparator, was available to carers throughout the study period. Participants and researchers were unblinded to the intervention. There were 3 cohorts of participants: carers, volunteers, and staff; participants were recruited from their communities. The primary outcome measure was perceived carer social support measured using the Medical Outcomes Study-Social Support Survey. Volunteers and staff provided feedback on their participation in Verily Connect as qualitative data. Qualitative data were collected from all cohorts of participants through interviews and focus groups. Process evaluation data were collected through interviews and memos written by research staff. Data on the costs of implementing Verily Connect were collected by the research team members and evaluated by a health economist.ResultsBetween August 2018 and September 2019, a total of 113 participants were recruited. There were 37 (32.7%) carers, 39 (34.5%) volunteers, and 37 (32.7%) health service staff. The study was complex because of the involvement of multiple and varied communities of carers, volunteers, health service staff, and research team members originating from 5 universities. Web-based technologies were used as intervention strategies to support carers and facilitate the process of undertaking the study.ConclusionsThe Verily Connect trial enabled the testing and further development of a web-based approach to increasing support for carers of people living with dementia across a diverse rural landscape in Australia. This protocol provides an example of how to conduct a pragmatic evaluation of a complex and co-designed intervention involving multiple stakeholders.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001213235; https://tinyurl.com/4rjvrasf.International registered report identifier (irrid)RR1-10.2196/33023.

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Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol.

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Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol.

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