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Eczema Reminder and Accountability Program (ERAP)

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ClinicalTrials.gov Identifier: NCT03735459
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Hamilton Allergy
Information provided by (Responsible Party):
Vince Wu, McMaster University

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Behavioral: Patient reminders and accountability questionnaires Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of an Atopic Dermatitis Education, Reminder, and Accountability Program on Patient Adherence to Treatment and Outcome of Atopic Dermatitis
Estimated Study Start Date : November 5, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic atopic dermatitis.
  • Age 0 to 16.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735459


Contacts
Contact: Vince Wu 905-525-4674 wuv3@mcmaster.ca
Contact: Jason Ohayon, MD 905-525-4674 ohayonj@hamiltonallergy.ca

Locations
Canada, Ontario
Hamilton Allergy Recruiting
Hamilton, Ontario, Canada, L8S 1G5
Contact: Vince Wu    905-525-4674    wuv3@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Hamilton Allergy
Investigators
Principal Investigator: Vince Wu McMaster University

Publications:
Responsible Party: Vince Wu, McMaster Co-op Student, McMaster University
ClinicalTrials.gov Identifier: NCT03735459     History of Changes
Other Study ID Numbers: ERAP
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vince Wu, McMaster University:
Treatment adherence and compliance

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases