Eczema Reminder and Accountability Program (ERAP)

August 13, 2019 updated by: Vince Wu, McMaster University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1G5
        • Hamilton Allergy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic atopic dermatitis.
  • Age 0 to 16.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patient reminder

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.
Behavioral: Patient reminders and accountability questionnaires
Participants who are assigned to the patient reminder arm will receive text messages 1, 2, and 4 weeks after enrollment. These text messages will encourage participants to adhere to the provided treatment plan, and ask participants to complete questionnaires to assess their adherence to treatment (in-house Adherence Questionnaire) and severity of eczema (PO-SCORAD) for that week.
NO_INTERVENTION: No patient reminder/control

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: From 1 week post date of randomization until 6 weeks post date of randomization. Time frame: 5 weeks.

Participants will complete the Adherence Questionnaire (AQ) to assess their adherence to the eczema treatment plan provided.

Participants in arm 1 (reminders) will complete the AQ on weeks 1, 2, 4, and 6 post randomization.

Participants in arm 2 (no reminders) will complete the AQ on week 6 post randomization.

The AQ will be scored for week 6 post randomization and compared between arms 1 and 2 to determine the impact of the ERAP on 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
Time Frame: 6 weeks.

To assess the impact of eczema on the family's quality of life, the participants' parents/guardians will be asked to complete the Family Dermatology Life Quality Index (FDLQI).

Family members of participants in both arms 1 and 2 will be asked to complete the FDLQI on the date of randomization and 6 weeks post randomization.

The change in FDLQI between the date of randomization and 6 weeks post randomization will be compared between arms 1 and 2 to assess the impact of the ERAP on the family's quality of life.
6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Hamilton Allergy

Investigators

  • Principal Investigator: Vince Wu, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2018

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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