Clinical trial NCT03467490: Self-care Management Program for Dry Eye Disease Patients Using the heiQ
Official title: Assessing a Self-care Management Program for Dry Eye Disease Patients Using the Health Educational Intervention Questionnaire
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change score in heiQ subscales
timeFrame: 2 months
Secondary outcomes:
measure: Mean Change scores in OSDI scores
timeFrame: 2 Months
measure: Mean change score in heiQ subscale 1:Health-directed activity
timeFrame: 2 months
measure: Mean change score in heiQ subscale 1: Health-Directed activity
timeFrame: 2 months
measure: Mean change score in heiQ subscale 2: Positive and active engagement in life
timeFrame: 2 months
measure: Mean change score in heiQ subscale 2: Positive and active engagement in life
timeFrame: 2 months
measure: Mean change score in heiQ subscale 3: Self-monitoring and insight
timeFrame: 2 months
measure: Mean change score in heiQ subscale 3: Self-monitoring and insight
timeFrame: 2 months
measure: Mean change score in heiQ subscale 4: Constructive attitudes and approaches
timeFrame: 2 months
measure: Mean change score in heiQ subscale 4: Constructive attitudes and approaches
timeFrame: 2 months
measure: Mean change score in heiQ subscale 5: Skill and technique acquisition
timeFrame: 2 months
measure: Mean change score in heiQ subscale 5: Skill and technique acquisition
timeFrame: 2 months
measure: Mean change score in heiQ subscale 6: Social integration and support
timeFrame: 2 months
measure: Mean change score in heiQ subscale 6: Social integration and support
timeFrame: 2 months
measure: Mean change score in the heiQ subscale 7: Health service navigation
timeFrame: 2 months
measure: Mean change score in the heiQ subscale 7: Health service navigation
timeFrame: 2 months
measure: Mean change score in heiQ subscale 8: Emotional distress
timeFrame: 2 months
measure: Mean change score in heiQ subscale 8: Emotional distress
timeFrame: 2 months
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
References: