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临床试验/NCT03735459
NCT03735459已完成不适用

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

McMaster University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Change in severity of eczema

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Chronic atopic dermatitis.
  • Age 0 to 16.

排除标准

  • 未提供

研究组 & 干预措施

Patient reminder

Experimental

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.

干预措施: Patient reminders and accountability questionnaires (Behavioral)

No patient reminder/control

No Intervention

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.

结局指标

主要结局

Change in severity of eczema

时间窗: 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.

次要结局

  • 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(6 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vince Wu

McMaster Co-op Student

McMaster University

研究点 (2)

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