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

Dry Eye Disease Clinical Trial

— heiQ  

Official title:

Assessing a Self-care Management Program for Dry Eye Disease Patients Using the Health Educational Intervention Questionnaire

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03467490
• Other study ID #: 109377
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: May 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this study is to assess a self-care management program for dry eye disease (DED) patients using the Health Educational Intervention Questionnaire (heiQ). The heiQ is tool that facilitates a comprehensive evaluation of patient education and self- management interventions for patients with chronic conditions.

Dry Eye Disease is a chronic and may be a progressive condition. Currently, there is no gold standard in the diagnosis or treatment of dry eye disease, but several management options are available. Just like other chronic conditions like diabetes, patients with dry eye must engage in disease modifying behaviours and perform self-care measures, in addition to taking pharmaceutical agents. Patient education is the foundation of an effective management plan.

Various educational programs have been developed in the past for chronic diseases like psoriasis, diabetes, and cardiovascular disease. However, there are limited studies evaluating self-management and educational interventions for patients with ocular diseases or DED. This research team has developed a program to educate patients on self-management of DED. The educational component of the intervention includes a series of short videos and a self-care handbook. Both the video series and handbook include topics ranging from the causes of DED, basic anatomy of the eye, and self-care skills to manage DED symptoms in various environments, such as the work environment and seasonal changes. This intervention aims to deliver useful information about DED, increase patient knowledge and awareness of strategies to reduce and manage symptoms of DED.

The research team will administer two questionnaires at two different time points to all participants-once at baseline and once at two months post-intervention. The first questionnaire is the Ocular Surface Disease Index (OSDI). This questionnaire is used to determine the severity of dry eye symptoms. The second questionnaire is the Health Educational Impact Questionnaire (heiQ). The heiQ is a validated instrument for health education and self-management programs of chronic diseases. It is comprised of 40 questions that represent 8 independent domains. Those domains include: Health-directed activity, Positive and active engagement in life, Self-monitoring and insight, Constructive attitudes and approaches, Skill and technique acquisition, Social integration and support, Health service navigation, and Emotional distress. Results from the heiQ will serve to provide evidence as to whether this educational intervention is effective and should be placed in clinical practice.

Potential participants will be recruited through Dr. Mather's clinical practice at the Ivey Eye Institute at St. Josephs's Hospital London, ON. A Letter of Information (LOI) and an Invitation Poster will be mailed to potential participants. There will be approximately 130 participants recruited from Dr. Mather's Clinic at the Ivey Eye Institute. The participants will be randomly assigned to the treatment arm or the controlled arm. The intervention in total will take up to 4 hours (2 hours in both sessions). In the first session (baseline) following the consent the first heiQ and OSDI will be completed by all the participants. The treatment group (65 participants) will watch a series of educational videos and will leave the baseline session with a DED handbook. The treatment group will agree not to share information from the session and the DED handbook with anyone until after session two. During the second session (2- months post intervention) all the participants will be asked to come back to St. Joseph's hospital to complete the second heiQ and OSDI. At this session all participants will be invited to watch the educational videos. All participants will be provided a DED handbook and all the participants will be asked to complete a feedback survey that will be provided. No data will be collected after the administration of the second set of questionnaires. Participants that have questions if any will have the opportunity to ask the ophthalmologist.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 30, 2020
• Est. primary completion date: January 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants will be considered eligible for inclusion in the study if they are:

1. 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)

2. at least 18 years of age

3. capable of communicating in English 4) willing and able to receive the educational intervention

5) willing and able to conduct DED self-care at home as needed

Exclusion Criteria:

Participants will be considered ineligible for participation in the study if any of the following criteria are met:

1. They are currently participating in other similar studies

2. They are currently undergoing or have undergone any type of self-care management/educational program for dry eye disease

3. 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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Behavioral:
• DED self-management
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.

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Change scores in OSDI scores	Mean change in scores of OSDI from baseline to 2 month post-intervention for each arm of the study	2 Months
Secondary	Mean change score in heiQ subscale 1:Health-directed activity	mean change score in the heiQ subscale 1 (Health-directed activity) from baseline to 2-months post intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 1: Health-Directed activity	Mean change score in the heiQ subscale 1 (Health-directed activity) from baseline to 2- month post intervention for each individual participant	2 months
Secondary	Mean change score in heiQ subscale 2: Positive and active engagement in life	Mean change score in heiQ subscale 2 (Positive and active engagement in life) from baseline to 2-months post-intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 2: Positive and active engagement in life	Mean change score in the heiQ subscale 2 (Positive and active engagement in life) from baseline to 2-months post-intervention for each individual participant	2 months
Secondary	Mean change score in heiQ subscale 3: Self-monitoring and insight	Mean change score in the heiQ subscale 3 (Self-monitoring and insight) from baseline to 2-months post-intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 3: Self-monitoring and insight	Mean change score in the heiQ subscale 3 (Self-monitoring and insight) from baseline to 2-months post-intervention for each individual participants	2 months
Secondary	Mean change score in heiQ subscale 4: Constructive attitudes and approaches	Mean change score in the heiQ subscale 4 (Constructive attitudes and approaches) from baseline to 2-months post-intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 4: Constructive attitudes and approaches	Mean change score in the heiQ subscale 4 (Constructive attitudes and approaches) from baseline to 2-months post-intervention for each individual participant	2 months
Secondary	Mean change score in heiQ subscale 5: Skill and technique acquisition	Mean change score in the heiQ subscale 5 (Skill and technique acquisition) from baseline to 2-months post-intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 5: Skill and technique acquisition	Mean change score in the heiQ subscale 5 (Skill and technique acquisition) from baseline to 2-months post-intervention for each individual participant	2 months
Secondary	Mean change score in heiQ subscale 6: Social integration and support	Mean change score in the heiQ subscale 6 (Social integration and support) from baseline to 2 months post intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 6: Social integration and support	Mean change score in heiQ subscale 6 (Social integration and support) from baseline to 2 months post intervention for each individual participant	2 months
Secondary	Mean change score in the heiQ subscale 7: Health service navigation	Mean change score in heiQ subscale 7 ( Health service navigation) from baseline to 2-months post-intervention for each arm of the study	2 months
Secondary	Mean change score in the heiQ subscale 7: Health service navigation	Mean change score in heiQ subscale 7 ( Health service navigation) from baseline to 2-months post-intervention for each individual participant	2 months
Secondary	Mean change score in heiQ subscale 8: Emotional distress	Mean change score in heiQ subscale 8 (Emotional Distress) from baseline to 2-months post intervention for each arm of the study	2 months
Secondary	Mean change score in heiQ subscale 8: Emotional distress	Mean change score in heiQ subscale 8 (Emotional Distress) from baseline to 2-months post intervention for each individual participant	2 months