Sarcoidosis Patient Assessment and Resource Companion App for Fatigue

1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
+1 More
Sarcoidosis Patient Assessment and Resource Companion App - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Fatigue

Study Summary

SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

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Eligible Conditions

  • Fatigue
  • Sarcoidosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Sarcoidosis Patient Assessment and Resource Companion App will improve 4 primary outcomes and 5 secondary outcomes in patients with Fatigue. Measurement will happen over the course of Week 0 and Week 24.

Month 6
Number of participants who achieve treatment satisfaction
Number of participants who complete the study
Number of participants who maintain adherence to twice daily breathing awareness meditation sessions
Proportion of Participants Recruited
Week 24
Change in Sarcoidosis Associated Fatigue
Changes in Autonomous Motivation
Changes in Quality of Life
Changes in Self-Efficacy
Changes in Stress

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Enhanced Standard Care Control Group
SPARC Group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sarcoidosis Patient Assessment And Resource Companion App is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SPARC Group
Behavioral
Enhanced Standard Care Control Group
Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the duration of the study, approximately 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly throughout the duration of the study, approximately 6 months for reporting.

Who is running the study

Principal Investigator
W. E. J.
Prof. W. Ennis James, MD
Medical University of South Carolina

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are at least 18 years old. show original
Sarcoidosis diagnosis based on established criteria
able to speak, hear, and understand English
You have an elevated score on the SAF. show original
owns smartphone with current data plan
willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can sarcoidosis be cured?

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A recent treatment trial with naltrexone, a drug that inhibits neuronal transmission, reduced sputum production and reduced pain without affecting lung or systemic manifestations of sarcoidosis.

Unverified Answer

What are the signs of sarcoidosis?

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A variety of lung lesions can be found in sarcoidosis. A chest radiograph, pulmonary function testing, and chest MRI are useful in excluding pulmonary tuberculosis. Lung biopsy is of no additional help. Clinical status is the most important determinant of prognosis, and there is a high incidence of chronic lung disease.

Unverified Answer

What causes sarcoidosis?

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It is likely that sarcoidosis results from a complex interaction of both genetic and environmental factors. Sarcoidosis is sometimes described as a hypersensitivity reaction, but that view is erroneous. Sarcoid is a benign disease, as long as patients avoid drugs and other stimuli that might trigger a sarcoid reaction that may have serious side-effects. The immunology of sarcoidosis is still largely unknown.

Unverified Answer

What are common treatments for sarcoidosis?

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Many patients with sarcoidosis have positive T-cell immunostimulation results that require active, immunosuppressive therapy for management. The incidence of sarcoidosis among blood donors is not well understood, but the likelihood that positive T-cell immunostimulation test results can justify restricting blood donation remains questionable given the low risk for developing sarcoidosis. The use of corticosteroids is not without risk although they are commonly used in sarcoidosis. The majority of patients are treated with corticosteroids but the rate of relapse is high. Antipsychotic drugs such as Halcion are often prescribed to psychotic sarcoidosis patients for the purposes of treatment of hallucinations and depression.

Unverified Answer

How many people get sarcoidosis a year in the United States?

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About 25,000 people are diagnosed each year with sarcoidosis in the United States. Males are much more commonly affected than females. Nonunion of the fingers and facial nerve may occur in sarcoidosis. The risk of developing sarcoidosis increases with exposure to environmental tobacco smoke and with a family history of sarcoidosis.

Unverified Answer

What is sarcoidosis?

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Sarcoidosis affects almost 10 million people worldwide, and is often undetected, with symptoms that are similar to infectious and malignant diseases. Its signs and symptoms, both internal and external, must not be confused with tuberculosis, tuberculosis of the sarcoid (TB), and lymphoma, so this is especially critical when diagnosis is needed. \n

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What is the average age someone gets sarcoidosis?

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The average age of diagnosis was 34.1 years. It is important to recognize sarcoidosis in those older than 50 years (n=11). The average disease duration was 16.2 years (n=36). Both age and duration of the disease are significant clinical factors to consider when dealing with sarcoidosis. It had a prevalence of 4.4 cases for every 1000 in Caucasians, while in African Americans the prevalence rate was 19 cases per 1000.

Unverified Answer

How does sarcoidosis patient assessment and resource companion app work?

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In particular a patient companion interface will be an effective system for patient and doctor communication. The app can be used to exchange questions and patient data and to provide a patient resource. It also helps patients make good first contact. Patients found the app helpful in their medical care and are willing to use the app for long-term follow-ups or to provide patient advocates at the start of care. This app would be especially useful for patients with sarcoidosis as it was well liked and helps patients to manage their health but it can be useful in the majority of patients that are not seriously ill but just need a patient advocate and support.

Unverified Answer

Is sarcoidosis patient assessment and resource companion app safe for people?

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Findings suggest that sarcoidosis patients are willing and eager to utilize a sarcoidosis patient assessment and resource companion app developed based on the patient-oriented approach.

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Is sarcoidosis patient assessment and resource companion app typically used in combination with any other treatments?

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A free, iPhone applications (CSAR) has been successfully combined in one practice with either oral or topical GCs in this tertiary sarcoidosis clinic, with positive clinical and patient-reported outcomes. The CSAR is intended for use in a sarcoidosis management program that includes a patient assessment and resource companion app that is used along with other treatment modalities and is based on patients' goals for treatment.

Unverified Answer

Who should consider clinical trials for sarcoidosis?

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Clinical trials are an exciting approach to new treatments for sarcoidosis, as has been shown in the treatment of severe chronic obstructive pulmonary disease. Clinical trial eligibility criteria are defined by patient demographics, disease characteristics and treatment type. All of these considerations should be addressed in future research to create a more efficacious treatment option for sarcoidosis. Clin Trial Registry. ClinicalTrials.gov (NCT00256618).

Unverified Answer

What does sarcoidosis patient assessment and resource companion app usually treat?

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Patients of different backgrounds tend to attribute different types and amount of care depending on their beliefs and preferences. This information can assist clinicians to allocate resources efficiently and effectively to patients, even with the variable degree of illness. This information can be utilized as an important adjunct to the patient assessment tool for personalized care.

Unverified Answer
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