The purpose of the study is to improve the quality of future clinical trials in bullous pemphigoid (BP), the investigators will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months.
The study team plans to recruit 45 subjects from the autoimmune blistering disease clinic at Emory Dermatology Clinic. The plan is to improve the quality of future clinical trials in bullous pemphigoid (BP), the team will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months. This time frame will allow completion of both aims in the three year time period. Aim 1 will evaluate the BPDAI scoring over time with specific reductions in the activity score as future outcomes for therapeutic response and assess changes in patient reported outcomes particularly related to pruritus for future clinical trial endpoints. Aim 2 will focus on the development of teledermatology platform for improving patient recruitment and retention. The data from this proposal will be critical for future BP clinical trials and clarify gaps in the current knowledge related to the natural disease history of BP patients on standard-of-care therapies, changes in BPDAI scores over time, and pruritus specific outcome measures to define the quality of life impact.
Study Type
OBSERVATIONAL
Enrollment
21
Emory Dermatology Clinic
Atlanta, Georgia, United States
Change in Bullous pemphigoid disease area index (BPDAI)
Change in Bullous pemphigoid disease area index (BPDAI) activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity (worse outcome).
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Change in ItchyQol score
ItchyQoL focuses on pruritus as the main symptom impacting quality of life. ItchyQol score is based on an averaged 10-point visual analogue scale (VAS) over three time periods. Lower score correlates with better outcome.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Change in Autoimmune Bullous Disease Quality of Life score (ABQoL)
The Autoimmune Bullous Disease Quality of Life (ABQoL) score is a 17 item questionnaire assessing quality of life in patients with autoimmune blistering diseases. It is a patient reported score. Each question ranges from 0 to 3 points, with higher scores indicating poorer quality of life. The maximum ABQOL score is 51.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Change in Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score
The Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score is a patient reported score. The score is a 17 item questionnaire assessing quality of life in patients with autoimmune blistering diseases. Each question ranges from 0 to 3 points, with higher scores indicating poorer quality of life. The maximum TABQOL score is 51.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
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Change in patient and physician global assessment
The Physician and Patient Global Assessments will assess skin related health on a 0-5 scale at each visit. The lower score correlates with disease improvement (better outcome).
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Number of participants with confidence that the dermatologist can help by looking at photos
This outcome is part of the patient satisfaction survey regarding teledermatology (TD) visits in order to encourage patient enrollment and retention for the length of the trial. Higher number of patients correlates with better outcome.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Number of participants with confidence that the teledermatology visit is more convenient than going to the dermatology clinic
This outcome is part of the patient satisfaction survey regarding teledermatology (TD) visits in order to encourage patient enrollment and retention for the length of the trial. Higher number of patients correlates with better outcome.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Number of participants that believe they will use the teledermatology service again
This outcome is part of the patient satisfaction survey regarding teledermatology (TD) visits in order to encourage patient enrollment and retention for the length of the trial. Higher number of patients correlates with better outcome.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Change in teledermatology satisfaction score
Teledermatology satisfaction will be evaluated using a survey that includes 3 questions. Possible score ranges from 0 to 3, with higher score correlating with better outcome.
Time frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline