Identifying Enablers of Participant Engagement in Clinical Trials of Consumer Health Technologies: A Qualitative Study of flu@home (Preprint)

2020 ◽  
Author(s):  
Spurthy Dharanikota ◽  
Cynthia M LeRouge ◽  
Victoria Lyon ◽  
Polina Durneva ◽  
Matthew Thompson
Keyword(s):  
Clinical Trials ◽  
Technology Acceptance ◽  
Attribution Theory ◽  
Financial Incentives ◽  
Large Scale ◽  
Digital Health ◽  
Drop Out ◽  
Evidence Based ◽  
Structured Interviews ◽  
Health Technologies

BACKGROUND Clinical trials are fraught with challenges such as inadequate enrollment, lack of fidelity to interventions, and high drop-out rates. However, such trials are essential to support large-scale implementation of crucial consumer healthcare technologies (CHTs) such as smartphone supported home diagnostic tests (Smart-HT). A rise in the recent trend of self-managing health using CHTs highlights the importance of efficient and successful CHT trials. Understanding the reasons underlying individuals’ participation in trials could inform the design and execution of future trials of CHTs. OBJECTIVE We aimed to identify the enablers of participation in clinical trials of CHTs and summarize our findings in an evidence-based framework. We used an instantiation of a specific CHT currently in trial, Smart-HT, which is an app accompanied by home-based diagnostic testing of influenza called flu@home. METHODS Based on the digital health engagement model (DIEGO) and technology acceptance model (TAM), we proposed a preliminary research framework of enablers for participants’ engagement in trials of CHTs. Further, based on the attribution theory, we categorized the enablers into dispositional and situational factors. The framework guided the confidential and semi-structured interviews and resultant transcript coding. 31 individuals who previously participated in the diagnostic accuracy pilot study of flu@home were recruited to complete the semi-structured interviews via email and received a 25$ gift card once completing the interview. RESULTS In addition to finding support and a detailed understanding of the proposed preliminary framework, we identified new themes in our analysis that extend our evidence-based framework. Situationally, we found that financial incentives and insurance status influenced trial engagement for flu@home. Motivation to advance medical research, personal innovativeness, altruism, curiosity, positive attitude, and potential to minimize doctor’s visits emerged as new dispositional enablers for trial engagement in our study. CONCLUSIONS Our findings and proposed framework provide insights into the context of trial engagement for CHTs that require testing, particularly an instantiation of Smart-HT involving testing for influenza. We suggest several trial design and trial engagement strategies to enhance these trials' financial and scientific viability, paving the way for advancements in patient care. Furthermore, our study also offers practical strategies to trial organizers to enhance participants’ enrollment and engagement in clinical trials of CHTs.

scholarly journals The role of economic, educational and social resources in supporting the use of digital health technologies by people with T2D: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sophie Turnbull ◽  
Patricia J. Lucas ◽  
Alastair D. Hay ◽  
Christie Cabral
Keyword(s):  
Social Networks ◽  
Social Status ◽  
Digital Health ◽  
Self Care ◽  
Social Resources ◽  
Health Interventions ◽  
Structured Interviews ◽  
Health Technologies ◽  
Digital Skills ◽  
Care Support

Abstract Background Type 2 Diabetes (T2D) is a common chronic disease, with socially patterned incidence and severity. Digital self-care interventions have the potential to reduce health disparities, by providing personalised low-cost reusable resources that can increase access to health interventions. However, if under-served groups are unable to access or use digital technologies, Digital Health Technologies (DHTs) might make no difference, or worse, exacerbate health inequity. Study aims To gain insights into how and why people with T2D access and use DHTs and how experiences vary between individuals and social groups. Methods A purposive sample of people with experience of using a DHT to help them self-care for T2D were recruited through diabetes and community groups. Semi-structured interviews were conducted in person and over the phone. Data were analysed thematically. Results A diverse sample of 21 participants were interviewed. Health care practitioners were not viewed as a good source of information about DHTs that could support T2D. Instead participants relied on their digital skills and social networks to learn about what DHTs are available and helpful. The main barriers to accessing and using DHT described by the participants were availability of DHTs from the NHS, cost and technical proficiency. However, some participants described how they were able to draw on social resources such as their social networks and social status to overcome these barriers. Participants were motivated to use DHTs because they provided self-care support, a feeling of control over T2D, and personalised advice or feedback. The selection of technology was also guided by participants’ preferences and what they valued in relation to DHTs and self-care support, and these in turn were influenced by age and gender. Conclusion This research indicates that low levels of digital skills and high cost of digital health interventions can create barriers to the access and use of DHTs to support the self-care of T2D. However, social networks and social status can be leveraged to overcome some of these challenges. If digital interventions are to decrease rather than exacerbate health inequalities, these barriers and facilitators to access and use must be considered when DHTs are developed and implemented.

scholarly journals Evaluation of the Implementation Process of the Mobile Health Platform ‘WelTel’ in Six Sites in East Africa and Canada Using the Modified Consolidated Framework for Implementation Research (mCFIR)

2020 ◽  
Author(s):  
Samia El Joueidi ◽  
Kevin Bardosh ◽  
Richard Musoke ◽  
Binyam Tilahun ◽  
Maryam Abo Moslim ◽  
...  
Keyword(s):  
Implementation Research ◽  
Digital Health ◽  
Descriptive Analysis ◽  
Scale Up ◽  
Implementation Process ◽  
Evidence Based ◽  
Structured Interviews ◽  
User Friendliness ◽  
Domain 3 ◽  
And Performance

Abstract Background: Health systems globally are investing in integrating secure messaging platforms for virtual care in clinical practice. Implementation science is essential for adoption, scale-up, spread and maintenance of complex evidence-based solutions in clinics with evolving priorities. In response, the mHealth Research Group modified the existing Consolidated Framework for Implementation Research (mCFIR) to evaluate implementation of virtual health tools in clinical settings. WelTel® is an evidence-based digital health platform widely deployed in various geographical and health contexts. Objectives: To identify the facilitators and barriers for implementing WelTel and to assess the application of the mCFIR tool in facilitating focus groups in different geographical and health settings. Methodology: Both qualitative and semi-quantitative approaches were employed. Six mCFIR sessions were held in three countries with 51 key stakeholders surveyed. The mCFIR tool consists of 5 Domains and 25 Constructs and was built and distributed through Qualtrics XM. “Performance ” and “Importance” scores were valued on a scale of 0 to 10 (Mean + SD). Descriptive analysis was conducted using R computing software. NVivo 12 Pro software was used to analyze mCFIR responses and to generate themes from the participants’ input. Semi-structured interviews were conducted with the focus group facilitators to understand their experience using the mCFIR tool. Results: We observed a parallel trend in the scores for Importance and Performance. Of the five Domains, Domain 4 (End-user Characteristics) and Domain 3 (Inner Settings) scored highest in Importance (8.9 + 0.5 and 8.6 + 0.6, respectively) and Performance (7.6 + 0.7 and 7.2 + 1.3, respectively) for all sites. Domain 2 (Outer Setting) scored the lowest in both Importance and Performance for all sites (7.6 + 0.4 and 5.6 + 1.8). Areas of strengths included timely diagnosis, immediate response, cost-effectiveness, user-friendliness, and simplicity. Areas for improvement included training, phone accessibility, health authority’s engagement, and literacy. Conclusion: The mCFIR tool allowed for a comprehensive understanding of the barriers and facilitators to the implementation, reach, and scale-up of digital health tools. Participants emphasized the importance of creating partnerships with external organizations and health authorities in order to achieve sustainability and scalability.Trial Registration: NCT02603536 – November 11, 2015NCT01549457 – March 9, 2012

scholarly journals EXPLORING THE POWER OF COMBINATORIAL HEALTH TECHNOLOGIES TO SUPPORT SELF-MANAGEMENT OF COPD AMONG OLDER PEOPLE

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S443-S443
Author(s):  
Sandra Varey ◽  
Mandy Dixon ◽  
Alejandra Hernandez ◽  
Ceu Mateus ◽  
Tom Palmer ◽  
...  
Keyword(s):  
Older People ◽  
Large Scale ◽  
Digital Health ◽  
Self Management ◽  
Chronic Obstructive ◽  
Test Bed ◽  
Long Term Conditions ◽  
Health Technologies ◽  
Healthcare Needs ◽  
The Impact

Abstract Ways to address the increasing healthcare needs of older people are a priority for the National Health Service (NHS) in England. The NHS England Test Bed programme was designed to trial new models of care that are supported by digital health technologies. This paper reports on findings from one Test Bed programme, the Lancashire and Cumbria Innovation Alliance (LCIA) – a partnership between NHS England, industry and Lancaster University, which ran from 2016 to 2018. A key aim of the LCIA Test Bed was to explore the extent to which supported self-care telehealth technology helped older people with long-term conditions to better self-manage their own care, promoting independence and enabling them to remain at home for longer. Each patient received a combination of health technologies over a six-month period. This paper presents results from the qualitative data that formed part of a large-scale mixed-methods evaluation. Specifically it draws on the analysis of 34 observational interviews with 17 participants with chronic obstructive pulmonary disease (COPD) to understand the role of these technologies in the self-management of their care. The data revealed that the majority of participants felt more confident about self-managing COPD as a result of their participation in the programme. These increases in confidence were the result of participants’ increased knowledge and skills in managing their COPD. The paper demonstrates how patients learned to better manage their respiratory condition, the impact of this learning on their daily lives and that of their family carers, and the implications for healthcare practice.

scholarly journals The role of economic, educational and social resources in supporting the use of digital health technologies by people with T2D: a qualitative study

2020 ◽  
Author(s):  
Sophie Turnbull ◽  
Patricia Lucas ◽  
Alastair D Hay ◽  
Christie Cabral
Keyword(s):  
Social Networks ◽  
Social Status ◽  
Digital Health ◽  
Self Care ◽  
Social Resources ◽  
Health Interventions ◽  
Structured Interviews ◽  
Health Technologies ◽  
Digital Skills ◽  
Care Support

Abstract BackgroundType 2 Diabetes (T2D) is a common chronic disease, with socially patterned incidence and severity. Digital self-care interventions have the potential to reduce health disparities, by providing personalised low-cost reusable resources that can increase access to health interventions. However, if under-served groups are unable to access or use digital technologies, Digital Health Technologies (DHTs) might make no difference, or worse, exacerbate health inequity. Study aimsTo gain insights into how and why people with T2D access and use DHTs and how experiences vary between individuals and social groups.MethodsA purposive sample of people with experience of using a DHT to help them self-care for T2D were recruited through diabetes and community groups. Semi-structured interviews were conducted in person and over the phone. Data were analysed thematically.ResultsA diverse sample of 21 participants were interviewed. Health care practitioners were not viewed as a good source of information about DHTs that could support T2D. Instead participants relied on their digital skills and social networks to learn about what DHTs are available and helpful. The main barriers to accessing and using DHT described by the participants were availability of DHTs from the NHS, cost and technical proficiency. However, some participants described how they were able to draw on social resources such as their social networks and social status to overcome these barriers. Participants were motivated to use DHTs because they provided self-care support, a feeling of control over T2D, and personalised advice or feedback. The selection of technology was also guided by participants’ preferences and what they valued in relation to DHTs and self-care support, and these in turn were influenced by age and gender.ConclusionThis research indicates that low levels of digital skills and high cost of digital health interventions can create barriers to the access and use of DHTs to support the self-care of T2D. However, social networks and social status can be leveraged to overcome some of these challenges. If digital interventions are to decrease rather than exacerbate health inequalities, these barriers and facilitators to access and use must be considered when DHTs are developed and implemented.

scholarly journals ProACT - A Digital Platform to Support Self-Management of Multiple Chronic Conditions: Findings in Relation to Engagement during a one-year Proof-of-Concept Trial (Preprint)

2020 ◽  
Author(s):  
Julie Doyle ◽  
Emma Murphy ◽  
Shane Gavin ◽  
Alessandra Pascale ◽  
Stephane Deparis ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Conditions ◽  
Digital Health ◽  
Self Management ◽  
Multiple Chronic Conditions ◽  
User Engagement ◽  
Proof Of Concept ◽  
Structured Interviews ◽  
Health Technologies ◽  
Care Approach

BACKGROUND Self-management, a core activity for older adults living with multiple chronic conditions (multimorbidity), is challenging, requiring the person to engage in multiple tasks such as symptom monitoring, recognition of exacerbations, medication adherence and inter-stakeholder communication. A digital, integrated care approach is a critical part of the solution, however, there is a dearth of literature on this topic. Furthermore, there is little research on older adults’ acceptability, usage and experiences of engaging with digital health technologies, particularly over long periods of time. OBJECTIVE The objectives were to (1) co-design and develop a digital health platform, called ProACT, to facilitate older adults self-managing multimorbidity, with support from their care network (CN); (2) evaluate end user engagement and experiences with the platform through a 12-month trial. METHODS The ProACT digital health platfrom is presented. The platform was evaluated in a year-long proof-of-concept (PoC) action research trial with 120 older persons with multimorbidity (PwMs) in Ireland and Belgium. Alongside the technology, participants had access to a clinical triage service responding to symptom alerts, and a technical helpdesk. Interactions with the platform during the PoC trial were logged to determine engagement, semi-structured interviews were conducted with participants and analysed using inductive thematic analysis methods, while usability and user burden were examined using validated questionnaires. RESULTS This article presents the ProACT platform and its components, along with findings on engagement with the platform and its usability. Of the 120 participants who took part, 24 withdrew before the end of the study while three passed away. The remaining 93 participants actively used the platform until the end of the trial, on average taking two or three health readings daily over the course of the trial, in Ireland and Belgium respectively. Participants reported ProACT to be usable and of low burden. Findings from interviews outline that participants experienced multiple benefits as a result of using ProACT, including improved self-management, improved health and wellbeing and support from the triage service. For those who withdrew, barriers to engagement were poor health and frustration when technology didn’t work as expected. CONCLUSIONS This is the first study to present findings from a longitudinal study of older adults using digital health technology to self-manage multiple chronic conditions. Our findings show that older adults sustained engagement with the technology and found it usable. Potential reasons for this include a strong focus on user-centred design and engagement throughout the project lifecycle, resulting in a platform that met user needs, as well as the integration of behavior change techniques and personal analytics into the platform. The provision of triage and technical support services alongside the platform during the trial were also important facilitators of engagement. INTERNATIONAL REGISTERED REPORT RR2-10.2196/preprints.22125

scholarly journals COVID-19 and Cardiovascular System. Part 3. COVID-19 Current Treatment Approaches: Evidence-Based Review

2021 ◽  
Vol 10 (3) ◽  
pp. 438-451
Author(s):  
M. K. Vasilchenko ◽  
A. A. Ivannikov ◽  
A. N. Yesaulenko ◽  
Kh. G. Alidzhanova ◽  
S. S. Petrikov
Keyword(s):  
Clinical Trials ◽  
Cardiovascular System ◽  
Mechanism Of Action ◽  
Treatment Strategy ◽  
Large Scale ◽  
Management Plan ◽  
Current Treatment ◽  
Evidence Based ◽  
Potential Mechanism ◽  
System Part

Unified management plan and treatment strategy for COVID-19 patients are yet to be discovered. Many trials on COVID-19 interventions have been registered or are ongoing. In this article the results of large-scale clinical trials on COVID-19 treatment are presented, the potential mechanism of action of some drugs is discussed, the features of the main pharmacological and non-pharmacological therapeutic options for COVID-19 patients are described.

Chinese Pharmacopoeia Revisited: A Review of Anti-Depression Herbal Sources

2021 ◽  
Vol 16 (12) ◽  
pp. 1934578X2110593
Author(s):  
Dongyi Hu ◽  
Jiayu Gao ◽  
Xiao Yang ◽  
Ying Liang
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Life Quality ◽  
Herbal Medicines ◽  
Antidepressant Drugs ◽  
New Drugs ◽  
Chinese Herbs ◽  
Evidence Based ◽  
Chinese Pharmacopoeia ◽  
Bupleuri Radix

Depression, which can be accompanied by many fatal diseases and a low life quality, has become the leading cause of ill health and disability worldwide. However, Chinese Pharmacopoeia, the most authoritative and evidence-based encyclopedia of Traditional Chinese Medicine (TCM), could contain leads and insights into the development of new antidepressant drugs. In this work, nine herbal medicines with ‘dispel melancholy functions’ specifically documented in Chinese Pharmacopoeia have been comprehensively reviewed with respect to clinical trials, and phytochemical and pharmacological aspects. The nine drugs are Rosae Chinensis Flos, Croci Stigma, Albiziae Cortex and Flos, Roase Rugosae Flos, Curcumae Radix, Hyperici Perforati Herba, Cyperi Rhizoma and Bupleuri Radix. The mechanisms of action of their functional antidepressant compounds, including gallic acid, hypericin, kaempferol, crocetin, crocin, quercetin, luteolin, isorhamnetin, curcumin, hyperforin, adhyperforin, catechin, rutin, puerarin, and saikosaponins A and D, have been collected and discussed. These traditional Chinese herbs and their active compounds provide a promising resource to develop effective new antidepressant drugs in future. Moreover, mechanistic investigations, safety verification and large-scale clinical trials are still expected to finally transform such TCM-based antidepressant resources to new drugs for patients suffering from depression.

scholarly journals “Sometimes I don’t have a pulse, and I’m still alive!” Healthcare providers on digital health techs

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
F Tomasella ◽  
H M Morgan
Keyword(s):  
Digital Health ◽  
Healthcare Providers ◽  
Future Research ◽  
Structured Interviews ◽  
Clinical Value ◽  
Health Technologies ◽  
Advantages And Disadvantages ◽  
Health Related ◽  
Potential Benefits ◽  
Change Promotion

Abstract Background Digital health technologies (DHTs) are increasingly becoming an integral part of our lives, healthcare field included. The WHO recently has even released the first digital health guidelines for worldwide intervention. Commercially available DHTs (e.g. smartphones, smartwatches, apps) may hold significant potential in healthcare, upon successful and constructive integration. Literature on the topic is split between enthusiasm for the potential benefits, and concerns about reliability and effectiveness. Little is known about what healthcare professionals (HCPs) have experienced so far with patients and what they believe the main issues for implementation may be. This study aims to investigate current perceptions of HCPs towards self-tracked health-related outputs from devices and apps available to the public. Methods Nine HCPs volunteered to take part in semi-structured interviews. Data were thematically analysed adopting a pre-constructed framework (deductive approach) based on current (April 2019) literature and the findings from the first two interviews. Results The following main themes were identified and explored in detail: HCPs' experience, perceived knowledge and views on DHTs; advantages and disadvantages; barriers towards healthcare implementation and solutions; future perspectives. While most participants were adopters of DHTs and held positive views about them, their overall experience with patients and the technology was limited. Potential reasons for this included factors such as time/resources availability; colleagues' mindset; lack of evidence of effectiveness for practice; privacy/data security concerns. Conclusions The potential advantages of DHTs' adoption in healthcare are substantial - e.g. patient autonomy, time/resources saving, health and behaviour change promotion. However, future research is warranted focussing on addressing barriers, minimising disadvantages, and assessing the clinical value of commercially available DHTs. Key messages We explored healthcare providers’ views on the role of commercial digital health techs in clinical practice. Despite some privacy and reliability concerns, commercial digital health techs show promise.

Trends in Clinical Trials Reports in Common Cancers Between 1989 and 2000

2003 ◽  
Vol 21 (9) ◽  
pp. 1850-1858 ◽  
Author(s):  
Bruce E. Hillner
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Sample Size ◽  
Financial Incentives ◽  
Cancer Biology ◽  
Pilot Trial ◽  
The United States ◽  
Evidence Based ◽  
Pilot Trials ◽  
Female Genital

Purpose: Cancer clinical trials can be dichotomized into pilot (phase I and phase II) and randomized controlled clinical trials (RCTs). The best data source for evidence-based medicine is from RCTs. However, many patients prefer to enroll onto pilot trials, and many investigators prefer to conduct or refer their patients to pilot trials. This exploratory study sought to describe the epidemiologic patterns of clinical trial reports in common cancers. Methods: A structured review was conducted of MEDLINE citations of all English clinical trials reports published between 1989 and 2000 in breast, lung, colorectal, prostate, and female genital cancers, plus leukemias and lymphomas. Each report was classified by design (RCT, pilot, or other) and country. The abstracts of RCTs were reviewed for sample size. Reports addressing screening or prevention were excluded. Results: A total of 12,035 reports, of which 3,560 were from RCTs, were found. The annual growth in RCT reports in breast, colorectal, and prostate cancer was significant (range, 4.8% to 8.5% per year) but was insignificant in leukemias, lymphomas, and female genital and lung cancers (range, 0.1% to 4.3% per year). Within each cancer, the average sample size per report did not change during the 12 years. Nonrandomized trial reports increased on average 15.1% per year (range, 10.1% to 23.2%). The United States accounted for 30% of all RCT reports and 45% of pilot trial reports. Conclusion: The faster growth in nonrandomized compared with RCT reports may reflect rapid advances in cancer biology or different structural, commercial, and financial incentives, especially in the United States compared with Europe. Unless additional studies show evidence of an increase in their quality, the modest growth in RCT reports may limit future evidence-based cancer care.

scholarly journals Young People’s Perspectives on and Experiences of Health-Related Social Media, Apps, and Wearable Health Devices

2018 ◽  
Vol 7 (8) ◽  
pp. 137 ◽  
Author(s):  
Victoria A. Goodyear ◽  
Kathleen M. Armour
Keyword(s):  
Social Media ◽  
Young People ◽  
Digital Health ◽  
Wearable Devices ◽  
Evidence Based ◽  
Policy Makers ◽  
Health Technologies ◽  
Related Information ◽  
Health Related ◽  
Shape Influence

: It has been reported from numerous international and socio-economic contexts that young people are becoming increasingly interested in and/or using social media, apps, and wearable devices for their health. Yet, there are few robust empirical accounts on the types of health-related information young people find, select, and use, the reasons for their choices, and how young people use these technologies in a way that influences their health-related knowledge and behaviors. This paper synthesizes findings from three separate projects that investigated over 1600 young people’s (age 13–19) perspectives on and experiences of health-related social media, apps, and wearable health devices. The findings show that young people are both critical and vulnerable users and generators of digital health technologies. Many young people experience a range of positive benefits for their physical activity, diet/nutritional, and body image related behaviors. Yet there are a number of risks, and young people report on the power of digital health technologies to shape, influence, and change their health-related behaviors. The paper concludes by providing new and evidence-based direction and guidance on how relevant adults (including teachers, parents/guardians, health professionals/practitioners, policy-makers, and researchers) can better understand and support young people’s engagement with digital health technologies.

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