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Completed

NCT Number: NCT03735459

Eczema Reminder and Accountability Program

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.

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Key information

Conditions

Atopic Dermatitis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Allergy

Hamilton, Ontario, L8S 1G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic atopic dermatitis.
  • Age 0 to 16.

Exclusion criteria

-

Treatment and study plan

Patient reminders and accountability questionnaires

Behavioral

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Allergy

Registry information

Official study title

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

Acronym: ERAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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