Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab
|ClinicalTrials.gov Identifier: NCT01435265|
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : March 5, 2013
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment|
|Psoriasis||Behavioral: Standard nurse education Behavioral: Additional nurse education|
This is a phase IV randomized, prospective open label study to asses the efficacy of an extended nurse eduction program in improving adherence to the prescribed treatment regimen in the treatment of moderate to severe psoriasis vulgaris. Twenty subjects, male or female, ages 18 and older in good health with moderate to severe chronic plaque type psoriasis for whom adalimumab is indicated according to the adalimumab prescribing information. All subjects must have a negative TB skin test according to prescribing guidelines. Subjects must be starting adalimumab for the first time, prescribed by their physician.
This is an open label trial. All subjects will be receiving adalimumab as prescribed by their physician. Half the group will be randomized to receive the additional nurse education program, the other half will receive the normal education materials provided by their physician.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effectiveness of Nurse Education and Its Impact on Treatment Adherence in Subjects With Moderate to Severe Psoriasis Undergoing Treatment With Adalimumab|
|Study Start Date :||January 2010|
|Primary Completion Date :||April 2012|
|Study Completion Date :||April 2012|
Active Comparator: Normal Nurse Education
Subjects receive normal nurse education materials provided by their physician.
Behavioral: Standard nurse education
Standard-of-care education from a dermatology nurse on the proper use of adalimumab
Experimental: Additional Nurse Education-
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
Behavioral: Standard nurse education
Standard-of-care education from a dermatology nurse on the proper use of adalimumabBehavioral: Additional nurse education
Additional education from a nurse on the use of adalimumab. This will include discussion of the pre-study evaluation with the subject, design of an Individual Educational Plan based on the pre-study evaluation, and a 30-60 minute educational session with the nurse educator at each study visit. Additional information concerning the benefits of the local support group and National Psoriasis Foundation will be provided. Additional education on self-injection and the opportunity to practice self-injection under the supervision of a nurse will also be provided. Subjects will also receive reminder phone calls to take each scheduled dose.
- Change in Psoriasis Area Severity Index (PASI-75) [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months ]The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.
- Investigator's Global Assessment (IGA) of Psoriasis [ Time Frame: 12 months ]Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).
- Adherence to Adalimumab Treatment [ Time Frame: Baseline to 12 months ]Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435265
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Steven R Feldman, MD, PhD||Wake Forest University Health Sciences|