High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports

Ali, Zarqa; Anderson, Kristen; Chiriac, Andrei; Andersen, Anette; Ísberg, Ari Páll; Moreno, Fernando Gesto; Eiken, Aleksander; Thomsen, Simon Francis; Zibert, John R.

doi:10.1371/journal.pone.0235500

Cited by 16 publications

(16 citation statements)

References 24 publications

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“…The completion rate for this study was 35% (14/40), which was mostly as a result of unforeseen circumstances during the COVID-19 pandemic; yet, these could be addressed with better participant screening, monitoring, and engagement or by adopting a hybrid approach. Other digital studies have reported a completion rate between 50% and 80% [ 52 , 53 ]. It was cumbersome for participants to use 2 separate apps (ProofPilot and Cara Care), which led to inconsistent tracking with regard to diet and physical activity.…”

Section: Discussionmentioning

confidence: 99%

Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study

Abrahams¹,

O’Grady²,

Prawitt³

2022

JMIR Form Res

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Background The effect of dietary collagen on managing digestive symptoms is currently lacking in the literature. Objective To gain a better understanding of this issue, we conducted a 2-phase mixed methods study. Methods Phase 1 was a mixed methods design to explore current attitude and practice among consumers and health care practitioners. The findings were used to design an 8-week phase 2 digital study called Gutme! conducted in the United States in healthy female volunteers (BMI>25 kg/m2). Our aim was, first, to determine the feasibility of conducting a fully digital mixed methods study; second, the study explored the effect of an 8-week daily supplementation of 20 g dietary collagen peptide (Peptan) on digestive symptoms. Phase 2 was a prospective, open-label, longitudinal, single-arm study. Participation involved 2 weeks of baseline tracking (digestive symptoms, mood, stool, and lifestyle) using an app, followed by 8 weeks of tracking and taking 20 g collagen peptide supplement split into 2 dosages per day. Participants were required to complete a web-based symptom questionnaire at baseline, week 2, and week 8, as well as participate in 2 scheduled video interviews. Results Phase 1 revealed that consumer awareness of collagen for digestive health is low (64/204, 31.4%). Among the dietitians prescribing collagen for their patients, the most common dosage was 20 g a day with notable effects after 6 weeks of intake. Within the phase 2 study, of the 40 recruited participants, 14 (35%) completed the full course of supplementation. The findings indicate that 93% (13/14) of those who completed the study experienced a reduction in digestive symptoms, which included bloating. Conclusions A mixed methods digital study design is feasible and acceptable for collecting relevant data in a real-life setting. The use of a 20 g daily collagen peptide supplement may reduce bloating and improve mild digestive symptoms in otherwise healthy female adults in the absence of any other dietary or lifestyle interventions. Trial Registration ClinicalTrials.gov NCT04245254; https://clinicaltrials.gov/ct2/show/NCT04245254

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Section: Discussionmentioning

confidence: 99%

Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study

Abrahams¹,

O’Grady²,

Prawitt³

2022

JMIR Form Res

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“…The present study is a first‐time analysis of AD data from a previously published 8‐week, noninterventional, observational, fully remote decentralized feasibility study including patients with AD, designed to investigate whether a siteless trial could recruit nationwide, achieve high adherence, and prevent dropouts. 10 Patients with AD were recruited online through advertisements on social media (recruitment data are published elsewhere 10 ), and were included if they were 18 years or older, fulfilled the UK Diagnostic Criteria for Atopic Dermatitis, 11 and had at least one visible AD lesion at the time of recruitment. The AD lesion was confirmed by board certified dermatologists on a photograph taken by the patient as the study was decentralized without visit to a clinical study site.…”

Section: Methodsmentioning

confidence: 99%

Assessing anatomical distribution of atopic dermatitis identifies a cluster of patients with late onset and low risk of asthma and allergy: An observational study

Ali

Anderson²,

Andersen³

et al. 2023

Health Science Reports

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Background and Aims: A better understanding of distinct subgroups in atopic dermatitis (AD) is warranted. The aim was to identify and determine characteristics of clusters based on anatomical location of AD. Methods:In this 8-week, observational, decentralized study, patients with AD completed a baseline questionnaire about anatomical location and severity of AD, and a principal component analysis (PCA) was applied to identify clusters. The Patient-Oriented Eczema Measure (POEM) was completed weekly and photographs of affected body areas were captured by the participants' own smartphones. From the weekly photographs, the AD severity was evaluated using the intensity part of the SCORing Atopic Dermatitis.Results: Fifty-five participants were recruited, of which 53 completed the baseline questionnaire with a mean POEM of 14.5 (SD: 5.6). The PCA analysis revealed three clusters, with AD predominantly on the shins, knees, and genitals (Cluster 1), with involvement of the upper body (Cluster 2), and with AD on the hands and feet (Cluster 3). Cluster 1 had a lower mean POEM score (11.12, SD: 5.3) compared with Clusters 2 (12.64, SD: 4.5) and 3 (15.98, SD: 4.7), respectively (p = 0.007). Further, Cluster 1 had the highest age of AD onset (mean 9.5 vs. 2.5 and 4.7 years, p = 0.02) and the lowest proportion of asthma/allergy (47% vs. 82% and 90%, p = 0.01). Conclusion:Three clusters of patients with AD based on affected body areas were identified. The cluster with involvement of legs and genitals was characterized by the oldest age of AD onset and the lowest prevalence of asthma/allergy.

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“…Although some studies show an increase in patient retention rates in DCTs and better compliance with procedures than in conventional trials (due to the home setting, use of electronic reminders, an overall less burdensome participation etc. ), there is no full consensus regarding these aspects in the literature ( 17 , 18 ).…”

Section: The Risks and Benefits Of Dctsmentioning

confidence: 99%

Decentralized clinical trials (DCTs): A few ethical considerations

Petrini

Mannelli²,

Riva³

et al. 2022

Front. Public Health

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Decentralized clinical trials (DCTs) are studies in which the need for patients to physically access hospital-based trial sites is reduced or eliminated. The CoViD-19 pandemic has caused a significant increase in DCT: a survey shows that 76% of pharmaceutical companies, device manufacturers, and Contract Research Organizations adopted decentralized techniques during the early phase of the pandemic. The implementation of DCTs relies on the use of digital tools such as e-consent, apps, wearable devices, Electronic Patient-Reported Outcomes (ePRO), telemedicine, as well as on moving trial activities to the patient's home (e.g., drug delivery) or to local healthcare settings (i.e., community-based diagnosis and care facilities). DCTs adapt to patients' routines, allow patients to participate regardless of where they live by removing logistical barriers, offer better access to the study and the investigational product, and permit the inclusion of more diverse and more representative populations. The feasibility and quality of DCTs depends on several requirements including dedicated infrastructures and staff, an adequate regulatory framework, and partnerships between research sites, patients and sponsors. The evaluation of Ethics Committees (ECs) is crucial to the process of innovating and digitalizing clinical trials: adequate assessment tools and a suitable regulatory framework are needed for evaluation by ECs. DCTs also raise issues, many of which are of considerable ethical significance. These include the implications for the relationship between patients and healthcare staff, for the social dimension of the patient, for data integrity (at the source, during transmission, in the analysis phase), for personal data protection, and for the possible risks to health and safety. Despite their considerable growth, DCTs have only received little attention from bioethicists. This paper offers a review on some ethical implications and requirements of DCTs in order to encourage further ethical reflection on this rapidly emerging field.

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High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports

Cited by 16 publications

References 24 publications

Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study

Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study

Assessing anatomical distribution of atopic dermatitis identifies a cluster of patients with late onset and low risk of asthma and allergy: An observational study

Decentralized clinical trials (DCTs): A few ethical considerations

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