Dry Eye DiseaseheiQNCT03467490
Self-care Management Program for Dry Eye Disease Patients Using the heiQ
A study testing DED self-management in people with Dry Eye Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- DED self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be considered eligible for inclusion in the study if they are:
- 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
- 5) willing and able to conduct DED self-care at home as needed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dry Eye Disease
- Being tested
- DED self-management
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DED self-managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (17)
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
Measured: 2 Months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start24 Nov 2018
- Primary completion19 Jan 2019
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467490
- Sponsor's protocol ID
- 109377
- Acronym
- heiQ
- Status last verified
- May 2019
- First submitted
- 28 Feb 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Self-care Management Program for Dry Eye Disease Patients Using the Health Educational Intervention Questionnaire
- ClinicalTrials.gov ID
- NCT03467490
- Acronym / sponsor ID
- heiQ / 109377
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 24 Nov 2018 (actual)
- Primary completion
- 19 Jan 2019 (actual)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: DED self-management65 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 |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be considered eligible for inclusion in the study if they are:
- 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
- 5) willing and able to conduct DED self-care at home as needed
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DED self-managementThis 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. | Behavioural | Treatment |
Primary outcome
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
17 secondary outcomes
Mean Change scores in OSDI scores
Time frame: 2 Months
Mean change score in heiQ subscale 1:Health-directed activity
Time frame: 2 months
Mean change score in heiQ subscale 1: Health-Directed activity
Time frame: 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
Time frame: 2 months
Mean change score in heiQ subscale 3: Self-monitoring and insight
Time frame: 2 months
Mean change score in heiQ subscale 3: Self-monitoring and insight
Time frame: 2 months
Mean change score in heiQ subscale 4: Constructive attitudes and approaches
Time frame: 2 months
Mean change score in heiQ subscale 4: Constructive attitudes and approaches
Time frame: 2 months
Mean change score in heiQ subscale 5: Skill and technique acquisition
Time frame: 2 months
Mean change score in heiQ subscale 5: Skill and technique acquisition
Time frame: 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
Time frame: 2 months
Mean change score in the heiQ subscale 7: Health service navigation
Time frame: 2 months
Mean change score in the heiQ subscale 7: Health service navigation
Time frame: 2 months
Mean change score in heiQ subscale 8: Emotional distress
Time frame: 2 months
Mean change score in heiQ subscale 8: Emotional distress
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DED self-management in people with Dry Eye Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change score in heiQ subscales (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.