Self-care Management Program for Dry Eye Disease Patients Using the heiQ

NCT03467490 | Unknown

• 1 other identifier: 109377
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Dry Eye Disease (DED)is a chronic disease without a cure. Empowering patients to engage in better self-care requires knowledge of their disease and skills in self-management, which can lead to improved well-being and quality of life. The Investigation team has developed a DED self-management program (video series and educational booklet) that can be easily implemented into clinical use. The Investigators are going to use the Ocular Surface Disease Index (OSDI) to measure the dry eye in the participants. In addition, the research team plans to use the heiQ (validated questionnaire that assesses self-management and health education programs) to evaluate the DED self-management program by comparing results taken at baseline to 2 months after undergoing the self-management program.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Mean Change score in heiQ subscales

  Mean change in scores of each of the eight heiQ subscales from baseline to 2-months post-intervention for each arm of the study

  2 months

Secondary Outcomes (17)

• Mean Change scores in OSDI scores

  2 Months

• Mean change score in heiQ subscale 1:Health-directed activity

  2 months

• Mean change score in heiQ subscale 1: Health-Directed activity

  2 months

• Mean change score in heiQ subscale 2: Positive and active engagement in life

  2 months

• Mean change score in heiQ subscale 2: Positive and active engagement in life

  2 months

Study Arms (2)

Treatment

EXPERIMENTAL

65 participants will be invited to receive a one-day educational intervention (first study visit) at the Ivey Eye Institute. The educational intervention includes watching a short video series and receiving educational handouts which summarize the content of the videos. Participants will have access to the educational handbook for reference. At two months post-intervention, participants will be invited back to St. Joseph's Hospital to complete the second administration of the heiQ and OSDI. Participants will have an opportunity to ask the ophthalmologist any question during the question and answer period. Participants will then be asked to provide feedback on the video series using a participation satisfaction survey and will be given an educational handbook which may be used to as a reference/guide on how to self-manage

Behavioral: DED self-management

Control

NO INTERVENTION

Patients will continue with treatment as usual without any educational intervention. They will complete the heiQ and OSDI at baseline and 2 months later during a routine office visit. At the 2-month visit, participants will be asked to complete the second administration of the heiQ and OSDI before being offered the opportunity to view the videos series, receive the educational handbook, and provide feedback on the educational material.

Interventions

DED self-management BEHAVIORAL

This an educational intervention. The interventional will include watching a series of short videos and a DED handbook. The short videos will address the following topics: anatomy of the eye, pathophysiology of DED, treatment options for DED, management of DED with allergies/glaucoma/ computer use, and new developments in treatment and research of dry eye disease. The handbook will include tools and resources for self management of DED.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to severe dry eye disease patients (have a minimum score of 20 on the Ocular Surface Disease Index and minimum score of 5 on the Canadian Dry Eye Assessment)
• at least 18 years of age
• capable of communicating in English 4) willing and able to receive the educational intervention
• \) willing and able to conduct DED self-care at home as needed

You may not qualify if:

• Participants will be considered ineligible for participation in the study if any of the following criteria are met:
• They are currently participating in other similar studies
• They are currently undergoing or have undergone any type of self-care management/educational program for dry eye disease
• unable/unwilling to receive the educational intervention and complete the two administrations of the heiQ 4 ) Unable to communicate fluently in English as the videos and the heiQ survey are both only available in English.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 16, 2018
• Study Start: November 24, 2018
• Primary Completion: January 19, 2019
• Study Completion: July 30, 2020
• Last Updated: March 31, 2020

Record last verified: 2019-05

Locations

CA (1)