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Clinical Trials/NCT03735459
NCT03735459CompletedNot Applicable

Impact of an Atopic Dermatitis Education, Reminder, and Accountability Program on Patient Adherence to Treatment and Outcome of Atopic Dermatitis

McMaster University1 site in 1 country21 target enrollmentStarted: November 13, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Change in severity of eczema

Study Overview

Brief Summary

Eczema is a chronic disease that requires long term and extensive treatment. However patient adherence to the treatment plans provided to them by their healthcare providers is poor. Frequent follow-up appointments have been demonstrated to improve treatment adherence, this may be due to patients feeling a sense of accountability which motivates them to adhere to their treatment. However, although frequent follow-up appointments are effective, they are not feasible. The goal of the Eczema Reminder and Accountability Program (ERAP) is to assess the effectiveness of a patient reminder system on patient adherence to treatment and the outcome of eczema. Participants will receive weekly/biweekly text messages that encourage them to adhere to their treatment plan, and asks them to assess the severity of their eczema and adherence to treatment for that week using questionnaires. Participants are then asked to send the completed questionnaires to Hamilton Allergy. Should the ERAP improve eczema outcome and treatment adherence, the goal is to use the ERAP as a virtual follow-up to reduce the need for frequent in-office follow-ups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Chronic atopic dermatitis.
  • •Age 0 to 16.

Exclusion Criteria

  • Not provided

Arms & Interventions

No patient reminder/control

No Intervention

Participants in arm 2 are not sent text messages, and will not be asked to complete questionnaires 1, 2, and 4 weeks post enrollment. Participants will be asked to complete questionnaires during enrollment and 6 weeks post enrollment.

Enrollment: Participants will complete FDLQI and PO-SCORAD.

Week 6: Participants will complete FDLQI, PO-SOCRAD, and AQ.

Patient reminder

Experimental

Patient Oriented SCORAD (PO-SCORAD): Assess severity of eczema.

Adherence Questionnaire (AQ): Assess adherence to eczema treatment plan provided to them by their healthcare provider.

Family Dermatology Life Quality Index (FDLQI): Assess impact of the participant's eczema on the family's quality of life.

Enrollment: Participants will complete FDLQI and PO-SCORAD.

Week 1, 2, and 4: Participants will complete PO-SCORAD and AQ.

Week 6: Participants will complete FDLQI, PO-SOCRAD, and AQ.

Intervention: Patient reminders and accountability questionnaires (Behavioral)

Outcomes

Primary Outcomes

Change in severity of eczema

Time Frame: From date of randomization until 6 weeks post randomization. Time frame: 6 weeks.

Participants will complete the Patient Oriented SCORAD (PO-SCORAD) to assess the severity of their eczema. Participants in arm 1 (reminders) will complete the PO-SCORAD on the date of randomization, and weeks 1, 2, 4, and 6 post randomization. Participants in arm 2 (no reminders) will complete the PO-SCORAD on the date of randomization and 6 weeks post randomization. To assess the impact of the ERAP on the outcome/severity of eczema, the change between the PO-SCORAD score from randomization and week 6 post randomization will be compared for arm 1 and arm 2.

Secondary Outcomes

  • Treatment adherence(From 1 week post date of randomization until 6 weeks post date of randomization. Time frame: 5 weeks.)
  • Change in family quality of life(6 weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vince Wu

McMaster Co-op Student

McMaster University

Study Sites (1)

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