mobile health (mHealth)

August 2, 2019: AI and the Future of Psychiatry (Murali Doraiswamy, MBBS)

Posted on by Gina Uhlenbrauck

Speaker

Murali Doraiswamy, MBBS
Professor of Psychiatry and Behavioral Sciences
Duke School of Medicine

Topic

AI and the Future of Psychiatry

Keywords

Artificial intelligence; Machine learning; Psychiatry; Ethical adoption of technologies; Mental health; Wearables; Mobile health

Key Points

  • There is growing evidence from randomized controlled trials of the efficacy of using digital tools in mental health diagnosis and treatment.
  • Could artificial intelligence (AI) and machine learning technologies be used to:
    • Reduce the stigma associated with mental health treatment?
    • Predict the risk for future suicide?
    • Detect Alzheimer’s years before diagnosis?
  • Categories of AI applications include low-risk apps that measure but do not diagnose, and apps used in diagnosis or treatment that must meet the same high standards of evidence as medications.
  • Clinicians still struggle with how to integrate patient data from wearable devices. AI technology might help if it could be used to synthesize the data into a risk profile for an individual.

Discussion Themes

What are the roles of stress, exercise, and sleep in mental health, and can autonomic data from wearables help explain the variance in mental health symptoms?

To develop evidence thresholds for AI, we need larger scale public-private partnerships as well as pragmatic trials addressing key clinical questions.

Read more from Dr. Doraiswamy in How to Use Technology Ethically to Increase Access to Mental Healthcare.
Tags

#AI, #pctGR, @Collaboratory1

July 26, 2019: Digital in Trials: Improving Participation and Enabling Novel Endpoints (Craig H. Lipset)

Posted on by Gina Uhlenbrauck

Speaker

Craig H. Lipset
Former Head of Clinical Innovation, Pfizer

Topic

Digital in Trials: Improving Participation and Enabling Novel Endpoints

Keywords

Digital tools; Clinical trials; Participant experience; Patient engagement; Clinical Trials Transformation Initiative

Key Points

  • To improve trial participation, start by understanding the user/consumer; ie, the trial participant and his or her trial experience.
  • Digital improvements in clinical trials can involve these incremental steps:
    • Study planning that is data-driven, crowdsourced, and informed by artificial intelligence
    • Patient engagement that implements electronic consent, flexibility in location, digital concierge support, and data ownership
    • Study conduct that integrates remote monitoring, digital biomarkers, and electronically sourced data
    • Analysis and reporting that is automated and includes dissemination to trial participants

Discussion Themes

Will digital tools in medicine development enable improvement, disruption, or displacement?

Digital tools in development focus on breaking down barriers to participation, using digital to improve existing measurement or enable new endpoints, and automating processes and tasks while improving quality.

Tags

#pctGR, @Collaboratory1

April 26, 2019: The VERITAS Trial: Virtual Exercise Rehabilitation at the Intersection of Evidence, Implementation, and Policy (Janet Prvu Bettger, ScD)

Posted on by Gina Uhlenbrauck

Speaker

Janet Prvu Bettger, ScD, FAHA
Associate Professor
Duke Department of Orthopaedic Surgery
Duke Clinical Research Institute

Topic

The VERITAS Trial: Virtual Exercise Rehabilitation at the Intersection of Evidence, Implementation, and Policy

Keywords

Rehabilitation; Virtual physical therapy; Patient outcomes; Physical therapy; Orthopaedic surgery; Total knee replacement; Digital technology; Telehealth

Key Points

  • The VERITAS trial evaluated the effects of physical therapy–supported virtual exercise compared with traditional home- or clinic-based physical therapy after total knee replacement. Outcome measures included 90-day health service use costs; patient-centered outcomes; and differential improvement from 6 weeks to 3 months.
  • The Center for Connected Health Policy found that while most states currently have established telehealth policies for primary care providers, these often do not include physical or occupational therapists.
  • Tele-rehabilitation facilitates communication between the patient and physical therapist in real time. The VERA™ technology provides a virtual physical therapist assistant for patients and clinicians, offering a digital interface that includes patient education, longitudinal functional assessments, telehealth video conferencing, personalized exercises, and remote monitoring of patient progress.

Discussion Themes

Study results support effectiveness and safety hypotheses: that tele-rehabilitation is noninferior to traditional physical therapy with respect to range of motion, walking speed, pain, or rehospitalization. However, it was not shown that the intervention is noninferior with respect to falls after hospital discharge.

Because virtual physical therapy interventions can save total costs, prevent readmissions, and improve mobility, it will be important to expand access to tele-rehabilitation and to advance policies that include physical therapists.

Read more about the VERITAS project and at ClinicalTrials.gov.

Tags

#telehealth, #pctGR, @Collaboratory1

October 19, 2018: A New Path Forward for Using Decentralized Clinical Trials (Jeffry Florian, PhD, Annemarie Forrest, Penny Randall, MD, MBA)

Posted on by Gina Uhlenbrauck

Speakers

Jeffry Florian, PhD
Clinical Analyst, Office of New Drugs
FDA Center for Drug Evaluation and Research (CDER)

Annemarie Forrest
Clinical Trials Transformation Initiative (CTTI)

Penny Randall, MD, MBA
VP and Global Therapeutic Head, CNS
IQVIA

Topic

A New Path Forward for Using Decentralized Clinical Trials

Keywords

Decentralized clinical trials; Telemedicine; Mobile health; Clinical Trials Transformation Initiative; FDA

Key Points

  • Decentralized clinical trials (DCTs) are defined as those executed through telemedicine, mobile, or local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model; for example, shipping investigational medical product directly to the trial participant.
  • DCTs are not “all or nothing.” They exist in a broad continuum and can expand the reach of traditional clinical trial sites.
  • Potential benefits of DCTs apply to all trials in all disease areas but may offer particular advantages in rare diseases, where patients are generally limited in number or are highly geographically dispersed.
  • Mobile HCP training is similar to that required for standard investigative sites: Good clinical practice, protocol-specific training, human subject protections, data protection, and clinical trial billing.

Discussion Themes

Will a decentralized trial lead to less diverse patient populations as participants will need to be technology literate and have access to technology?

Decentralized clinical trial safety monitoring plans should not be held to a higher standard than with traditional trials unless merited by a particular circumstance. It is important to develop protocol-specific safety monitoring and communication escalation plans.

Download CTTI’s recommendations for decentralized clinical trials.

Tags

#telemedicine #pctGR, @PCTGrandRounds, @Collaboratory1, @CTTI_Trials @IQVIA_global @US_FDA

September 14, 2018: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials (John Hubbard, PhD, Barry Peterson, PhD, Cheryl Grandinetti, PharmD)

Posted on by Gina Uhlenbrauck

Speakers

John Hubbard, PhD
Healthcare Strategic Advisory Board
Genstar Capital

Barry Peterson, PhD
Independent Consultant

Cheryl Grandinetti, PharmD
Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance Evaluation
Center for Drug Evaluation and Research
Food and Drug Administration

Topic

Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

Keywords

Clinical trials; Mobile health technologies; Clinical Trials Transformation Initiative; CTTI; FDA; Data integrity

Key Points

  • The goal of CTTI’s Mobile Clinical Trials program is to develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission.
  • Potential benefits of using mobile technology include higher quality, patient-centric endpoints and fewer barriers to participation in clinical trials.
  • Data access issues to consider before selecting a mobile technology include:
    • How will the data generated by the mobile technology be accessed and used by the manufacturer?
    • What data will be provided by the manufacturer to the sponsor?
  • The mobile era creates new data security demands.

Discussion Themes

CTTI’s recommendations aim to help sponsors determine the right device to use, how to write the protocol for remote data capture, and how to protect and analyze the data.

Know what you want to measure before selecting the mobile technology. The appropriateness of the selection should be justified through verification and validation processes.

Ensure the authenticity, integrity, and confidentiality of data over its entire lifecycle.

To reduce risk in large trials, conduct feasibility studies before full implementation.

Visit CTTI for more recommendations and resources for mobile clinical trials.

 

Tags

@CTTI_Trials, @PCTGrandRounds, #MobileTech, #pctGR

August 28, 2018: Spotlight on a New NIH Collaboratory Trial: Nudge

Posted on by Damon Seils

More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management offer new opportunities to influence patients’ health behaviors and improve health outcomes.

“One of the real benefits of using technology is that it can be widely disseminated. Studying that dissemination process is really where we are in the field. So a pragmatic trial makes a lot of sense.” — Sheana Bull, PhD, MPH

The NIH Collaboratory is pleased to welcome the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) study to its portfolio of NIH Collaboratory Trials. The Nudge study will use mobile phone text messages and an artificial intelligence chatbot to deliver behavioral “nudges” to patients to improve medication adherence. The study will access population-level pharmacy data in 3 integrated healthcare delivery systems to test the effectiveness of the nudges on adherence and outcomes among patients with chronic cardiovascular conditions who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia.

The Nudge study is led by co–principal investigators Drs. Sheana Bull and Michael Ho of the University of Colorado with support from the National Heart, Lung, and Blood Institute. Watch a video interview with Drs. Bull and Ho, and read more about Nudge.

 

July 16, 2018: JAMA Editorial Highlights mSToPS Trial, Discusses Strengths and Challenges of Pragmatic Clinical Trials

Posted on by Damon Seils

A recent editorial in JAMA highlights the mHealth Screening to Prevent Strokes (mSToPS) randomized clinical trial in a discussion of the strengths and challenges of pragmatic clinical trials. The mSToPS trial, which studied patients at increased risk of atrial fibrillation who used a self-applied electrocardiogram sensor patch, found that immediate monitoring, compared with delayed monitoring, led to a higher rate of diagnosis after 4 months.

The editorial’s authors, Dr. Eric Peterson of Duke University and Dr. Robert Harrington of Stanford University, describe the mSToPS trial as an “innovative example of the potential (and challenges) inherent in a pragmatic IT trial.” The trial “scores quite high for its pragmatic approach” while offering lessons in the trade-offs that such an approach often requires.

The editorial notes that efforts like the NIH Collaboratory are bringing about innovations in health systems collaborations and clinical data platforms that “could provide the ideal setting to conduct highly pragmatic and efficient [randomized clinical trials] of the benefits, risks, and costs associated with novel health IT solutions.”