Eczema Reminder and Accountability Program

NCT ID: NCT03735459

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient reminders and accountability questionnaires

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chronic atopic dermatitis.
* Age 0 to 16.

Exclusion Criteria

\-
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Allergy

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Vince Wu

McMaster Co-op Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vince Wu

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton Allergy

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 21414011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17300244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26239125 (View on PubMed)

Other Identifiers

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ERAP

Identifier Type: -

Identifier Source: org_study_id

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