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Eczema Reminder and Accountability Program (ERAP)

Primary Purpose

Atopic Dermatitis, Eczema

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patient reminders and accountability questionnaires
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Treatment adherence and compliance

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic atopic dermatitis.
  • Age 0 to 16.

Exclusion Criteria:

-

Sites / Locations

  • Hamilton Allergy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient reminder

No patient reminder/control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in severity of eczema
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

Treatment adherence
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.
Change in family quality of life
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.

Full Information

First Posted
November 5, 2018
Last Updated
August 13, 2019
Sponsor
McMaster University
Collaborators
Hamilton Allergy
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1. Study Identification

Unique Protocol Identification Number
NCT03735459
Brief Title
Eczema Reminder and Accountability Program
Acronym
ERAP
Official Title
Impact of an Atopic Dermatitis Education, Reminder, and Accountability Program on Patient Adherence to Treatment and Outcome of Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Hamilton Allergy

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
Treatment adherence and compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient reminder
Arm Type
Experimental
Arm Description
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.
Arm Title
No patient reminder/control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient reminders and accountability questionnaires
Intervention Description
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 Outcome Measure Information:
Title
Change in severity of eczema
Description
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.
Time Frame
From date of randomization until 6 weeks post randomization. Time frame: 6 weeks.
Secondary Outcome Measure Information:
Title
Treatment adherence
Description
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.
Time Frame
From 1 week post date of randomization until 6 weeks post date of randomization. Time frame: 5 weeks.
Title
Change in family quality of life
Description
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.
Time Frame
6 weeks.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic atopic dermatitis. Age 0 to 16. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vince Wu
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Allergy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21414011
Citation
Stalder JF, Barbarot S, Wollenberg A, Holm EA, De Raeve L, Seidenari S, Oranje A, Deleuran M, Cambazard F, Svensson A, Simon D, Benfeldt E, Reunala T, Mazereeuv J, Boralevi F, Kunz B, Misery L, Mortz CG, Darsow U, Gelmetti C, Diepgen T, Ring J, Moehrenschlager M, Gieler U, Taieb A; PO-SCORAD Investigators Group. Patient-Oriented SCORAD (PO-SCORAD): a new self-assessment scale in atopic dermatitis validated in Europe. Allergy. 2011 Aug;66(8):1114-21. doi: 10.1111/j.1398-9995.2011.02577.x. Epub 2011 Mar 18.
Results Reference
background
PubMed Identifier
17300244
Citation
Basra MK, Sue-Ho R, Finlay AY. The Family Dermatology Life Quality Index: measuring the secondary impact of skin disease. Br J Dermatol. 2007 Mar;156(3):528-38. doi: 10.1111/j.1365-2133.2006.07617.x. Erratum In: Br J Dermatol. 2007 Apr;156(4):791.
Results Reference
background
PubMed Identifier
26239125
Citation
Bass AM, Anderson KL, Feldman SR. Interventions to Increase Treatment Adherence in Pediatric Atopic Dermatitis: A Systematic Review. J Clin Med. 2015 Jan 27;4(2):231-42. doi: 10.3390/jcm4020231.
Results Reference
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Eczema Reminder and Accountability Program

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