People, not digital for supporting patients in medical device clinical trials

May 13, 2018

1 in 7 American adults live alone

Medical device clinical trials are performed under conditions that are near to real-life use by the patient. That means that a medical device for monitoring cardiovascular (CV) risk, CHF (congestive heart failure) and other cardiac disorders is used by a subject in medical device clinical trial at home without the support and outside the controlled environment of a hospital or clinic.

Increasingly, individuals in developed and developing countries are living away from extended family or friends. There is substantial epidemiological evidence that social isolation may alter neurohormonal-mediated emotional stress, influence health behavior and result in cardiovascular (CV) risk.

What are the implications and tools at our disposal for supporting patients in medical device clinical trials who live at home alone?

Do patient-oriented Web sites such as help mitigate the risk of non-compliance and adverse events by connecting people to other people in a medical device clinical trial?

Or does online networking have a negative effect on the data collection and protocol compliance of medical device studies?

Medtech sponsors use self-service online help systems for supporting patients at home and helping them resolve technical and compliance issues – for example, helping patients resolve user login difficulties and comply with the treatment schedule.

But are those online support pages a substitute for listening, and relating by a a real human being?

In this article, Danny Lieberman, founder of, the leading cloud Automated detection and response   provider for medical device  companies, discusses risk, risk mitigation and how we should be using digital technology to help us discover and get most of the human connection.

Living on your own is something that we all dream about when in high school.

Living alone is great when you’re a 20 or 30 something with its social and economic benefits, but as people get older, living alone carries growing risk from social isolation.

The degree to which people are integrated with others may be as strongly predictive of incident myocardial infarction (MI) and coronary heart disease (CHD) survival as smoking, elevated cholesterol levels, and hypertension

A recent article in the Archives of Internal Medicine Living Alone and Cardiovascular Risk in Outpatients at Risk of or With Atherothrombosis reports on research by Jacob Udell et al on whether living alone is associated with increased mortality and cardiovascular risk.

What is atherothrombosis?

Atherothrombosis is the major cause of acute coronary syndromes (ACS) and cardiovascular death.

It is the leading cause of mortality in the industrialised world.

Atherosclerosis is a diffuse process that starts early in childhood and progresses asymptomatically through adult life. Later in life, it is clinically manifested as coronary artery disease, stroke, transient ischaemic attack, and peripheral arterial disease.

See Atherothrombosis: A widespread disease with unpredictable and life-threatening consequence

If you are age 40 to 60 and live alone, your CV system is at high risk.

The prevalence of living alone increases with age. Among participants aged 45 to 65 years, 66 to 80 years, and older than 80 years, 13.6%, 19.8%, and 34.6%, were living alone, respectively.

Living alone is also associated with an increased prevalence of CV risk factors, including hypertension, kidney failure, obesity, heart failure and smoking.

The risk of death from acute coronary syndromes for people who live alone, peaks in middle-age and dramatically goes down for people who lived alone who are over 80.

In participants 45 to 65 years of age, among whom living with others was more common, living alone was associated with a significantly higher risk of all-cause and CV mortality compared with participants living with others.

Although the prevalence of living alone nearly tripled among those older than 80 years, living alone was not associated with a higher risk of mortality in the oldest participants.

Thus, living alone at a younger age may be a marker of a stressful psychosocial situation, such as job strain or isolation, with adverse neurohormonal effects on the CV system, that may have more impact in youth to influence health behavior and wellness.

Can digital technology mitigate the risk of living alone?

With the ubiquity of Facebook, Twitter and social media sites like, it is natural to ask – does social networking for healthcare applications can mitigate the sense of isolation and therefore mitigate CV risk factors by connecting people who live alone with other people?

Despite the old proverb, misery loves company, the answer is probably not.

The popular patient site, extolls the wonderfully supportive aspects of the online patient community. Of course they do, they have to promote their web site.

MIT Professor Sherry Turkle believes otherwise

Online networks detach people from meaningful interactions with one another.

The book “Alone Together” by Sherry Turkle says that social networks are more like mutual isolation networks that detach people from meaningful interactions with one another and make them less human. Listen to her talk on TED. It’s fascinating and may change the way you think about phones and social media.

We expect more from technology and less from each other

CV risk for people living at home is real but it cannot be mitigated by logging on to Facebook or tweeting or exchanging messages on a forum. The little “sips” of conversation we have on social media are not a substitute for a real meeting or phone call and a complete conversation between two people.

In the case of people living at home, the necessity is real friendships and real interactions with real primary care teams.

Digital technology enables real interactions with clinical trial teams but is not a replacement
People who are at risk of cardiovascular (CV) disease need connections with real people who are also healthcare providers (and not just meaningful users tapping data into their Federally approved EHR systems…).

There is the demand side (the patients and people that live alone) and the supply side (the healthcare providers that can help people be healthier but are already stretched too thin).

Digital technology in medtech medical device clinical trials, is a tremendous force multiplier for primary care teams. A nurse can work with 100 home-alone people / day instead of 5. A front-line paramedic can screen queries from 300 people/day and connect them to a specialist as warranted.

Healthcare delivery using digital technology to people who live alone is cheap, because we eliminate office costs, travel costs and many of the IT costs by making the most of mobile and private networking technology without having to carry the burden of electronic medical records and government mandated data sharing.

When a nurse, or paramedic or specialist takes the time to explain things, patients feel respected and they remember the encounter as a positive experience and are more likely to take the nurse/paramedic/physician advice.

Most people do not live alone out of choice and in order to get to a higher level of social interactions and friendships, they need to take it step by step – especially if they are middle-aged and set in their ways.

Home alone and in a clinical trial – if you are home alone while participating in a clinical trial, having secure online access to a real person can be the difference between continuing the treatment and dropping out.

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