Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Skin diseases account for 30% of all physician office visits. In the United States, access to dermatologists remains a significant challenge for those in underserved or rural communities. To increase access to specialists and improve patient outcomes, this study will evaluate a team-based connected health (TCH) model that enables structured asynchronous online interactions among patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable effective management of chronic skin diseases via high-quality and efficient online care between providers and patients. TCH purports to bring direct and expedient specialist care to patients and PCPs in a location-independent and asynchronous manner. Specifically, TCH offers several ways that patients and providers can communicate online asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and (3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access dermatologists online asynchronously for consultations or to request a dermatologist to assume care of patient’s skin disease. With patient-dermatologist interactions, patients can upload clinical images and history online and obtain asynchronous evaluation and recommendations from dermatologists directly. Finally, PCPs have the option of managing their patients’ skin diseases online. Importantly, TCH applies efficient workflow that maximally supports providers and fosters multi-directional, informed communication among patients, PCPs, and dermatologists.

To evaluate the impact of TCH, the study team uses atopic dermatitis (AD) as a disease model. AD is a common, relapsing inflammatory skin disease affecting 32 million individuals in the U.S. AD is characterized by intense itching and red, scaly patches. It incurs significant morbidities and high healthcare costs. To address skin inflammation, itch, and psychosocial consequences, PCPs and dermatologists need to adopt a team-based approach to effectively manage all aspects of AD. The primary goal of the proposed research is to test whether the online TCH model results in equivalent improvements in disease severity and quality of life, provides better access to specialist care, and is cost- saving as compared to usual in-person care in pediatric and adult patients with AD. Specifically, the study team will conduct a pragmatic, cluster-randomized controlled equivalency trial and use validated measures to compare AD disease severity, health-related quality of life, and access to care between TCH and in-person care. The study team will also compare costs of the two healthcare delivery models from a societal perspective by conducting cost- minimization and sensitivity analyses. This proposal evaluates a significant innovation in specialty-care delivery that will likely result in improved patient outcomes, greater access to specialists, and cost savings. The study findings will be highly impactful and have immense dissemination potential to the management of many other chronic diseases.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           1 Year and older   (Child, Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • Age 1 year or older
  • Physician-diagnosed atopic dermatitis (AD)
  • Access to a digital-photo capturing device (mobile phone or camera) capable of capturing images with a minimum resolution of 1024x768 pixels
  • Access to internet
  • Able to establish care or have established care with providers
  • Provision of signed and dated informed consent and youth assent form

 

Exclusion Criteria:

  • Unable to fulfill study-related tasks by adult AD patients or parents or guardians of pediatric AD patients

 

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Study Location(s):

University of Southern California, Los Angeles, United States, 90007

Study Website:

https://www.clinicaltrials.gov/ct2/show/NCT03981926?term=April+Armstrong&rank=6

 

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