Using an Internet Study to Improve Adherence for Psoriasis Patients
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Purpose
| Condition | Intervention |
|---|---|
|
Psoriasis |
Behavioral: Internet Survey Drug: fluocinonide 0.05% ointment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Using an Internet Study to Improve Adherence for Psoriasis Patients |
- Measured MEMS Adherence [ Time Frame: 1 month, 3 months, 6 monthhs, 12 months ] [ Designated as safety issue: No ]
The measured adherence (MEMS®) of the Internet survey group compared to the standard-of-care control group after one month (short-term assessment) and twelve months (long-term assessment) of commencing the study
The MEMS® cap incorporates a microprocessor into the bottle cap of a standard medication bottle. Each time the bottle is opened for at least 3 seconds, the time and date of the opening are recorded. Subjects will be asked to bring the unused portion of the medication jar to each visit so that the medication can be "weighed and refilled". At each visit the information will be downloaded via the MEMS® communicator onto a computer database.
- MEMS cap relation to internet survey [ Time Frame: 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
The measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey.
The MEMS® cap incorporates a microprocessor into the bottle cap of a standard medication bottle. Each time the bottle is opened for at least 3 seconds, the time and date of the opening are recorded. Subjects will be asked to bring the unused portion of the medication jar to each visit so that the medication can be "weighed and refilled". At each visit the information will be downloaded via the MEMS® communicator onto a computer database.
- Disease Severity with PASI and IGA assessment [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]
The change (dynamic assessment) from baseline visit to each return visit (or end of treatment) in the Psoriasis Area Severity Index and Investigator's Global Assessment.
Investigator's Global Assessment (IGA): Similar to assessment performed in clinical practice, based on a 6-point scale from 0 (completely clear) to 5 (very severe). Treatment success is defined as score of 0 or 1 (clear or almost clear).
Psoriasis Area and Severity Index (PASI): The Psoriasis Area and Severity Index is commonly used in clinical trials as a granular measure of disease severity. It is weighted for area in each of the four body regions and scores erythema, induration and desquamation on an overall scale from 0-72. Treatment success is defined as a 75% reduction in PASI score from baseline value.
- MEMs cap data compared to PASI and IGA Assessment [ Time Frame: 1 month, 3 months, 6 months,12 months ] [ Designated as safety issue: No ]The measured adherence by the MEMS® cap in relation to the change (dynamic assessment) in the Psoriasis Area Severity Index and Investigator's Global Assessment.
| Enrollment: | 40 |
| Study Start Date: | October 2012 |
| Study Completion Date: | April 2016 |
| Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention - internet reminder survey
Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.
|
Behavioral: Internet Survey
Drug: fluocinonide 0.05% ointment
Other Names:
|
|
Experimental: Standard of care, no internet survey
Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.
|
Drug: fluocinonide 0.05% ointment
Other Names:
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Any male or female 18 years or older of age with a diagnosis of mild to moderate psoriasis by a dermatologist will be eligible for participation.
- Less than 20% of body surface involvement for psoriasis.
- Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- The subject is able to complete the study and comply with study instructions, including attending all study visits.
- In general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase health risk by study participation
Exclusion Criteria:
- Individuals younger than 18 years of age.
- Known allergy or sensitivity to topical fluocinonide.
- Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
- Introduction of any other prescription medication, topical or systemic, for psoriasis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for psoriasis must be on a stable dose for at least 3 months prior to enrollment.
- Any skin condition or disease that may require concurrent therapy or may confound evaluations
- Current enrollment in any research study involving an investigational drug
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01802580
| United States, North Carolina | |
| Wake Forest School of Medicine - Dermatology Clinic | |
| Winston Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Steven R Feldman, MD, PhD | Wake Forest School of Medicine |
More Information
| Responsible Party: | Steven R. Feldman, Professor, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01802580 History of Changes |
| Other Study ID Numbers: | IRB00021783 |
| Study First Received: | February 20, 2013 |
| Last Updated: | May 5, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Fluocinonide Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Allergic Agents |
ClinicalTrials.gov processed this record on September 30, 2016