scholarly journals Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study

2017 ◽  
Vol 19 (2) ◽  
pp. e50 ◽  
Author(s):  
Jeffrey Krischer ◽  
Peter F Cronholm ◽  
Cristina Burroughs ◽  
Carol A McAlear ◽  
Renee Borchin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rare Disease ◽  
Patient Recruitment ◽  
Web Based

scholarly journals A novel approach to conducting clinical trials in the community setting: Utilizing patient-driven platforms and social media to drive web-based patient recruitment

2019 ◽  
Author(s):  
Janelle Applequist ◽  
Cristina Burroughs ◽  
Artemio Ramirez ◽  
Peter A. Merkel ◽  
Marc E. Rothenberg ◽  
...  
Keyword(s):  
Social Media ◽  
Clinical Research ◽  
Rare Disease ◽  
Patient Recruitment ◽  
Research Approach ◽  
Marketing Theory ◽  
Disease Category ◽  
Web Based ◽  
Recruitment Methods ◽  
Research Studies

Abstract Background: Participant recruitment for clinical research studies remains a significant challenge for researchers. Novel approaches to recruitment are necessary to ensure that populations are easier to reach. In the context of rare diseases, social media provides a unique opportunity for connecting with patient groups that have representatively lower diagnosis rates when compared with more common maladies. We describe the implementation of designing a patient-centered approach to message design for the purposes of recruiting patients for clinical research studies for rare disease populations. Methods: Using an iterative research approach, we analyzed our previous experience of using web-based direct-to-patient recruitment methods to compare these online strategies with traditional center of excellence recruitment strategies. After choosing six research studies for inclusion in the previous study, in-depth, online interviews ( n = 37) were conducted with patients represented in each disease category to develop and test recruitment message strategies for social media and a Web-based platform for patients to access study information and pre-screen. Finally, relationships were established with Patient Advocacy Groups representing each rare disease category to ensure further dissemination of recruitment materials via their own social media networks. Results: Guided by social marketing theory, we created and tested various recruitment message designs. Three key message concepts preferred by patients emerged: (1) infographic; (2) positive emotional messages; and (3) educational information for sharing. A base study website that was created and edited based on qualitative user-testing. This website includes the option for potential participants to pre-screen and determine their eligibility for the study. Conclusions: Study participants report wanting to be involved in the design and implementation of recruitment approaches for clinical research studies. The application of the aforementioned methods could aide in the evolution of clinical research practices for the recruitment of both rare and common diseases, where patient-centric approaches can help to create targeted messages designs that participants pre-test and support.

scholarly journals A novel approach to conducting clinical trials in the community setting: Utilizing patient-driven platforms and social media to drive web-based patient recruitment

2020 ◽  
Author(s):  
Janelle Applequist ◽  
Cristina Burroughs ◽  
Artemio Ramirez ◽  
Peter A. Merkel ◽  
Marc E. Rothenberg ◽  
...  
Keyword(s):  
Social Media ◽  
Clinical Research ◽  
Rare Disease ◽  
Patient Recruitment ◽  
Research Approach ◽  
Marketing Theory ◽  
Disease Category ◽  
Web Based ◽  
Common Diseases ◽  
Research Studies

Abstract Background: Participant recruitment for clinical research studies remains a significant challenge for researchers. Novel approaches to recruitment are necessary to ensure that populations are easier to reach. In the context of rare diseases, social media provides a unique opportunity for connecting with patient groups that have representatively lower diagnosis rates when compared with more common diseases or illness. We describe the implementation of designing a patient-centered approach to message design for the purposes of recruiting patients for clinical research studies for rare disease populations. Methods: Using an iterative research approach, we analyzed our previous experience of using web-based direct-to-patient recruitment methods to compare these online strategies with traditional center of excellence recruitment strategies. After choosing six research studies for inclusion in the previous study, in-depth, online interviews (n=37) were conducted with patients represented in each disease category to develop and test recruitment message strategies for social media and a Web-based platform for patients to access study information and pre-screen. Finally, relationships were established with Patient Advocacy Groups representing each rare disease category to ensure further dissemination of recruitment materials via their own social media networks. Results: Guided by social marketing theory, we created and tested various recruitment message designs. Three key message concepts preferred by patients emerged: (1) infographic; (2) positive emotional messages; and (3) educational information for sharing. A base study website was designed and created based on the data from patient interviews. This website includes the option for potential participants to pre-screen and determine their eligibility for the study. Conclusions: Study participants report wanting to be involved in the design and implementation of recruitment approaches for clinical research studies. The application of the aforementioned methods could aide in the evolution of clinical research practices for the recruitment of both rare and common diseases, where patient-centric approaches can help to create targeted messages designs that participants pre-test and support.

scholarly journals Moving Online: A Pilot Clinical Trial of the Changing Talk Online (CHATO) Communication Education for Nursing Home Staff

2020 ◽  
Author(s):  
Kristine N Williams ◽  
Carissa K Coleman ◽  
Yelena Perkhounkova ◽  
Tim Beachy ◽  
Maria Hein ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nursing Home ◽  
Training Program ◽  
Effective Means ◽  
Posttest Score ◽  
Behavioral Symptoms ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Design And Methods

Abstract Background and Objectives Staff-resident communication is a critical part of nursing home (NH) care. Reducing elderspeak and increasing person-centered communication has been shown to reduce behavioral symptoms experienced by persons living with dementia. An online version of a successful classroom-based communication-training program that reduced staff elderspeak and resident behavioral symptoms was evaluated. The objective of this study was to establish feasibility and determine the preliminary effects of the online program in preparation for a national pragmatic clinical trial. Research Design and Methods Seven NHs were randomized to immediate intervention or wait-list control conditions. The NHs were provided with the web-based training program that staff individually accessed. Primary outcomes were knowledge scores and communication ratings of a video-recorded interaction, using pre- to post-training comparisons. Results Knowledge increased from a mean pretest score of 61.9% (SD=20.0) to a mean posttest score of 84.6% (SD=13.5) for the combined group. Knowledge significantly improved between Time 1 and Time 2 for the immediate intervention participants (p<.001), but not for the wait-list control participants (p=.091), and this difference was statistically significant (p<.001). Ability to recognize ineffective, inappropriate, non-person-centered, and elderspeak communication improved after training (p<.001). The magnitude of improvement in communication recognition was comparable to that of the original classroom format. Discussion and Implications The adapted communication intervention was feasible and improved knowledge and communication. Online instruction can improve access to quality education and is an effective means to improve dementia care by overcoming barriers to in-person training.

PATIENT RECRUITMENT ONTO A PHASE I CLINICAL TRIAL OF INTERLEUKIN 12 (IL-12) GENE THERAPY FOR CANCER

1997 ◽  
Vol 20 (5) ◽  
pp. 400
Author(s):  
D. Kinzler ◽  
H. Tahara ◽  
E. Elder ◽  
C. Johnson ◽  
N. Nguyen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gene Therapy ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Interleukin 12 ◽  
Patient Recruitment

Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient

2021 ◽  
Vol 16 ◽  
Author(s):  
Erica Winter ◽  
Scott Schliebner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Rare Disease ◽  
Rare Diseases ◽  
Statistical Analyses ◽  
Clinical Trial Designs ◽  
Novel Approaches

: Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. In recent years, there have been increased efforts by stakeholders to improve drug development in rare diseases through novel approaches to clinical trial designs and statistical analyses. We highlight and discuss some of the current and emerging approaches aimed at overcoming challenges in rare disease clinical trials, with a focus on the ultimate stakeholder, the patient.

scholarly journals Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047921
Author(s):  
Anna Marcuzzi ◽  
Kerstin Bach ◽  
Anne Lovise Nordstoga ◽  
Gro Falkener Bertheussen ◽  
Ilya Ashikhmin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neck Pain ◽  
Usual Care ◽  
Secondary Care ◽  
Self Management ◽  
Low Back ◽  
Musculoskeletal Health ◽  
Web Based ◽  
Management Intervention ◽  
Management Interventions

IntroductionLow back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help).Methods and analysisThis is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients’ and clinicians’ experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions’ adjunct to usual care.Ethics and disseminationThe trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic.Trial registration numberNCT04463043.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

10.2196/14744 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14744
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

Development and Patient Usability Analysis of a Veteran Centric Web-based Decision Aid for Lung Cancer Screening (Preprint)

2021 ◽  
Author(s):  
Marilyn Schapira ◽  
Sumedha Chhatre ◽  
Jason Prigge ◽  
Jessica Meline ◽  
Dana Kaminstein ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Cancer Screening ◽  
Medical Center ◽  
Clinical Care ◽  
Lung Cancer Screening ◽  
Potential Range ◽  
Medical Terminology ◽  
Web Based ◽  
System Usability Scale

BACKGROUND Web based tools developed to facilitate a Shared Decision Making (SDM) process may facilitate implementation of lung cancer screening (LCS), an evidence based intervention to improve cancer outcomes. Veterans have specific risk factors and shared experiences that impact the benefit and potential harms of LCS, so may value a Veteran centric LCS SDM too OBJECTIVE To develop and conduct usability testing of a LCS Decision Tool (LCSDecTool) designed for Veterans receiving care at a Veteran Affairs Medical Center (VAMC). METHODS A user-centered design approach was undertaken to develop the LCSDecTool. Usability of a prototype was assessed among 18 Veterans from two VA sites. Usability of a high fidelity version was assessed among 43 Veterans as part of a clinical trial. Outcomes included the System Usability Scale (SUS), the End User Computer Satisfaction (EUCS), and the Patient Engagement (PE) scale. Qualitative data from observations and short interviews with users were analyzed and themes pertaining to usability identified. RESULTS The mean (SD) in the pilot clinical trial (n=43) for the SUS (potential range 0 [low] to 100 [high] was 65.76 [15.23]); EUCS (potential range 1 [low] to 5 [high] was 3.91 [0.95]); and PE (potential range 1[low) to 5 [high] was 4.62 [0.67]). Time to completion of the LCSDecTool in minutes (median, intra-quartile range) was (13, 10-16). Emerging themes included: 1) a baseline gap in awareness of LCS with knowledge gained from using the LCSDecTool, 2) an interest in details about the LCS process, 3) the LCSDecTool was easy to use overall but specific navigation challenges identified, and 4) difficulty in understanding medical terminology. CONCLUSIONS The LCSDecTool demonstrates a good level of usability among Veterans when testing in the context of clinical care. Study findings will inform further modifications of the tool, including shortening the length and simplifying language. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02899754

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