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

March 27, 2020 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
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
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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change score in heiQ subscales
Time Frame: 2 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change scores in OSDI scores
Time Frame: 2 Months
Mean change in scores of OSDI from baseline to 2 month post-intervention for each arm of the study
2 Months
Mean change score in heiQ subscale 1:Health-directed activity
Time Frame: 2 months
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
Mean change score in heiQ subscale 1: Health-Directed activity
Time Frame: 2 months
Mean change score in the heiQ subscale 1 (Health-directed activity) from baseline to 2- month post intervention for each individual participant
2 months
Mean change score in heiQ subscale 2: Positive and active engagement in life
Time Frame: 2 months
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
Mean change score in heiQ subscale 2: Positive and active engagement in life
Time Frame: 2 months
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
Mean change score in heiQ subscale 3: Self-monitoring and insight
Time Frame: 2 months
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
Mean change score in heiQ subscale 3: Self-monitoring and insight
Time Frame: 2 months
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
Mean change score in heiQ subscale 4: Constructive attitudes and approaches
Time Frame: 2 months
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
Mean change score in heiQ subscale 4: Constructive attitudes and approaches
Time Frame: 2 months
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
Mean change score in heiQ subscale 5: Skill and technique acquisition
Time Frame: 2 months
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
Mean change score in heiQ subscale 5: Skill and technique acquisition
Time Frame: 2 months
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
Mean change score in heiQ subscale 6: Social integration and support
Time Frame: 2 months
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
Mean change score in heiQ subscale 6: Social integration and support
Time Frame: 2 months
Mean change score in heiQ subscale 6 (Social integration and support) from baseline to 2 months post intervention for each individual participant
2 months
Mean change score in the heiQ subscale 7: Health service navigation
Time Frame: 2 months
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
Mean change score in the heiQ subscale 7: Health service navigation
Time Frame: 2 months
Mean change score in heiQ subscale 7 ( Health service navigation) from baseline to 2-months post-intervention for each individual participant
2 months
Mean change score in heiQ subscale 8: Emotional distress
Time Frame: 2 months
Mean change score in heiQ subscale 8 (Emotional Distress) from baseline to 2-months post intervention for each arm of the study
2 months
Mean change score in heiQ subscale 8: Emotional distress
Time Frame: 2 months
Mean change score in heiQ subscale 8 (Emotional Distress) from baseline to 2-months post intervention for each individual participant
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 109377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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