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This study showed that Sidekick's digital therapeutic program was feasible for patients with peripheral artery disease.

Peripheral Artery Disease: Sidekick’s Feasibility Study Shows Promise For Patients

by Shadi Zarei, MD, MSc and Medically Reviewed by Elías Freyr Guðmundsson
5 minute read

Digital therapeutic innovations are revolutionizing patient care and the management of clinical conditions. Several studies have shown that digital programs can facilitate and enhance the quality of care for patients with different diseases, including rheumatological and dermatological disorders. But would digital programs be feasible and effective for patients with peripheral artery disease (PAD)? 

To answer this question, Sidekick Health entered a partnership with Bayer in 2019 and launched a digital medication management and lifestyle change platform for patients with PAD. 

The most recent feasibility study by Sidekick was presented at the American Heart Association’s EPI Lifestyle conference in 2022 and published in the conference proceedings in Circulation. The results showed that its novel Digital Therapeutic Program is feasible for patients with PAD. In this article, we’ll guide you through the study and investigate how PAD affects patients. 

Living With PAD

Peripheral artery disease is a progressive disorder characterized by the narrowing or blockage of arteries, excluding those that supply the heart or the brain. It’s estimated that more than 200 million people have PAD globally. Symptoms range from none to severe and can include recurrent fatigue, cramping, and pain known as intermittent claudication, which affects the lower limbs more than upper extremities.

Combined with the progression of the disease, the above symptoms can substantially impair individuals’ physical functionality and have a negative impact on the ability to perform daily activities, leading to disability and a subsequent loss of independence. 

PAD reduces the quality of life significantly and can lead to serious complications, including amputation and death.

Supporting patients in managing the symptoms, adhering to treatment, and modifying risk factors is therefore essential for controlling the disease and preventing serious complications. 

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Peripheral Artery Disease: The Need for Data

However, data is limited regarding the feasibility and effectiveness of an accessible digital program supporting patients with PAD. In response, Sidekick has developed a novel Digital Therapeutic Program to help patients with PAD incorporate healthy lifestyle changes and adhere to treatment, ultimately leading to better disease management and an improved quality of life. 

The program is delivered through a smartphone app and includes medication reminders, patient education, food logging, mindfulness training, and exercise and movement tracking. The key features of the PAD program are remote patient monitoring, altruistic rewards to motivate users for completing missions, and access to lifestyle coaches. 

The results from our feasibility study show that this digital therapeutic solution is feasible among patients with PAD, showing promise for real-world application. The section below features a summary of the study. 

Study Design

The study was a single-arm, interventional feasibility study that was conducted over four weeks. In this study:

  • Fourteen elderly patients with PAD were enrolled from two vascular surgery clinics in Sweden.
  • Participants used a therapeutic program delivered via a smartphone app
  • In-app data to assess the program’s feasibility was gathered throughout the study, while secondary clinical endpoints were assessed at baseline and follow up.  

Outcome Measures

The in-app data collected included information on engagement, retention, daily physical activity and the number of steps per day. Patients were also asked to track their PAD medication in the app during the program. 

Preliminary clinical outcomes were also measured using standardized questionnaires at baseline and post-intervention, including:

At the end of the study, participants were also asked to complete a satisfaction survey about their experience.

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Results

Fourteen patients were enrolled in the study with a median age of 72 years, including eight men (57%) and six women (43%). Of these, 11 used the program activities for four weeks, indicating a retention rate of 78%, and seven completed both pre- and post-intervention questionnaires. 

The in-app data of the Sidekick program users showed: 

  • Half of the patients performed at least 7.1 activities daily. 
  • The number of daily steps of half the participants was at least 4,500 steps a day.
  • The average physical activity rate increased from 21 to 33 minutes a day from week one to week four of the study.
  • 71% of patients who answered a post-program question agreed that the platform helped them to remember to take their medication.

Data from the clinical questionnaires showed no change in either the walking impairment or the vascular quality of life. Sidekick users were also largely satisfied with the program. 83% of users confirmed that they would recommend the program to others.

Conclusion

The study in question shows that Sidekick’s digital therapeutic program was feasible for patients with peripheral artery disease. Evidence also shows that the program helped patients to become more engaged with physical activities and medication adherence. 

Patients benefit from a user-friendly digital therapeutic solution that enables them to monitor and improve their physical activity, empowering them to incorporate healthy lifestyle changes that can lead to improved control of their disease. 

The success of this feasibility study has provided the foundation for a multicenter clinical trial, which is currently ongoing, to investigate the clinical effectiveness of the Sidekick digital program for patients with peripheral artery disease. 

Sidekick is confident that the promising results of this study will support its vision to establish the PAD program as a core therapeutic for patients with PAD by providing them with the support they need. 

Combining conventional PAD treatments with the Sidekick digital program can result in a holistic therapeutic plan that focuses on both pharmacological therapies and lifestyle changes, which, when combined, can reduce the risk of serious complications and improve quality of life.

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