Diabetes ComplicationsLionsDMedNCT02334137
A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
An observational study of Diabetes Complications and Diabetic Retinopathy, run by California Pacific Medical Center Research Institute.
Trial summary
The overarching purpose of this project is to provide diabetes education to the diverse patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at California Pacific Medical Center. Because of high clinic volume in a teaching environment, our patients often experience long wait times. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Complications, Diabetic Retinopathy
- What is being tested?
- iPad app, Educator sessions and Retinal photos
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The proposed subjects are diabetic patients already approved to be seen in the Lions Eye Clinic, specifically for dilated eye exam by a retinal specialist. This is a high-risk population with advanced disease and often with limited preexisting knowledge about diabetes, thus providing the motivation for these educational interventions.
Who may be able to join
- Type 1 or Type 2 diabetes (as defined by evident systemic findings OR recent hemoglobin A1c OR patient report, as specific blood sugar data and knowledge of particular medications are often limited in this population)
- Age 18-75
- Able and willing to provide informed consent
- Speak English, Spanish, or any other language for which a translator is present
Who cannot join
- Advanced visual acuity loss in both eyes which prevents adequate use of educational tools
- Pregnant women, elderly patients (>75 years old), children and adolescents (17 or younger)
- Non-English/Spanish speakers for whom a translator is not present
About this study
Official title: Providing Diabetes Services in the Lions Eye Clinic: a Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
The overarching purpose of this project is to provide diabetes education to the diverse patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at California Pacific Medical Center. Because of high clinic volume in a teaching environment, our patients often experience long wait times. The goal of this program is to utilize this wait time for diabetes education, a much-needed corollary to the eye care that patients receive at our clinic.
This pilot project will investigate the impact of a program like this in our patient population. Specifically, the investigators are investigating whether diabetes education delivered in an ophthalmology setting enhances patient understanding of diabetes (via knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This is a 6-month study that runs through April 2015, and looks at the impact of an interactive diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of patients who meet with a diabetes educator will also be shown their own retinal images (compared to a normal retina).
- Conditions
- Diabetes Complications, Diabetic Retinopathy
- Being tested
- iPad app, Educator sessions, Retinal photos
- Medical subject headings
- Diabetes Complications, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad appBehavioural
Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.
Educator sessionsBehavioural
A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.
Retinal photosBehavioural
A resident ophthalmologist will spend approximately 5 minutes showing patient their own retinal photos, compared to a normal retina, and explaining the pathology present (if applicable).
| Study group | Role | What they receive |
|---|---|---|
| iPad app | This group will have unlimited access to educational iPad app while waiting for ophthalmology visits. Receives: Behavioral: iPad app | |
| Educator sessions | This group will have unlimited access to educational iPad app AND at least one appointment with a certified diabetes educator or registered dietitian while waiting for ophthalmology visits. Receives: Behavioral: iPad app; Behavioral: Educator sessions | |
| Educator sessions + retinal photos | This group will have same access as "iPad app + education sessions" and in addition will be able to briefly review their own retinal photos (compared to normal retina) with a resident ophthalmologist during timeline of pilot program. Receives: Behavioral: iPad app; Behavioral: Educator sessions; Behavioral: Retinal photos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys)
Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions
Measured: Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention
Secondary outcomes (3)
Change from Baseline Hemoglobin A1c at 3 months
Provides estimate of patient's average blood sugar over past three months
Measured: Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention
Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)
Brief 3-4 question surveys to assess patient satisfaction with services offered, motivation to manage their disease process, and subjective improvement in knowledge after using educational services
Measured: 1 day
Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)
Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Vision Foundation
- Responsible party
- Sponsor
- Investigators
- Samuel J Reiter, MD, Study director, Resident Ophthalmologist, CPMCTaliva Martin, MD, Principal investigator, CPMC Ophthalmologist, Residency Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334137
- Sponsor's protocol ID
- Diabetes Ed at Lions Eye
- Acronym
- LionsDMed
- Status last verified
- Jan 2016
- First submitted
- 31 Dec 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Diabetes Services in the Lions Eye Clinic: a Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
- ClinicalTrials.gov ID
- NCT02334137
- Acronym / sponsor ID
- LionsDMed / Diabetes Ed at Lions Eye
- Conditions
- Diabetes Complications, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- Pacific Vision Foundation
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jan 2015 (estimated)
- 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.
The overarching purpose of this project is to provide diabetes education to the diverse patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at California Pacific Medical Center. Because of high clinic volume in a teaching environment, our patients often experience long wait times. The goal of this program is to utilize this wait time for diabetes education, a much-needed corollary to the eye care that patients receive at our clinic.
This pilot project will investigate the impact of a program like this in our patient population. Specifically, the investigators are investigating whether diabetes education delivered in an ophthalmology setting enhances patient understanding of diabetes (via knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This is a 6-month study that runs through April 2015, and looks at the impact of an interactive diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of patients who meet with a diabetes educator will also be shown their own retinal images (compared to a normal retina).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iPad app | – | Behavioral: iPad appThis group will have unlimited access to educational iPad app while waiting for ophthalmology visits. |
| Educator sessions | – | Behavioral: iPad app, Behavioral: Educator sessionsThis group will have unlimited access to educational iPad app AND at least one appointment with a certified diabetes educator or registered dietitian while waiting for ophthalmology visits. |
| Educator sessions + retinal photos | – | Behavioral: iPad app, Behavioral: Educator sessions, Behavioral: Retinal photosThis group will have same access as "iPad app + education sessions" and in addition will be able to briefly review their own retinal photos (compared to normal retina) with a resident ophthalmologist during timeline of pilot program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The proposed subjects are diabetic patients already approved to be seen in the Lions Eye Clinic, specifically for dilated eye exam by a retinal specialist. This is a high-risk population with advanced disease and often with limited preexisting knowledge about diabetes, thus providing the motivation for these educational interventions.
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetes (as defined by evident systemic findings OR recent hemoglobin A1c OR patient report, as specific blood sugar data and knowledge of particular medications are often limited in this population)
- Age 18-75
- Able and willing to provide informed consent
- Speak English, Spanish, or any other language for which a translator is present
Key exclusion criteria (3 listed)
- Advanced visual acuity loss in both eyes which prevents adequate use of educational tools
- Pregnant women, elderly patients (>75 years old), children and adolescents (17 or younger)
- Non-English/Spanish speakers for whom a translator is not present
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 |
|---|---|---|
| iPad appProvided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others. | Behavioural | Educator sessions, Educator sessions + retinal photos, iPad app |
| Educator sessionsA certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits. | Behavioural | Educator sessions, Educator sessions + retinal photos |
| Retinal photosA resident ophthalmologist will spend approximately 5 minutes showing patient their own retinal photos, compared to a normal retina, and explaining the pathology present (if applicable). | Behavioural | Educator sessions + retinal photos |
Primary outcome
Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys)
Time frame: Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention
Objective assessment of patient knowledge about diabetes using 13 multiple-choice questions
3 secondary outcomes
Change from Baseline Hemoglobin A1c at 3 months
Time frame: Participants will have repeat lab drawn at their next follow-up eye appointment, an expected average of 3 months post-intervention
Patient Satisfaction / Motivation / Subjective Improvement in Knowledge (brief surveys)
Time frame: 1 day
Change from Baseline in Patient Knowledge about Diabetes Immediately after using Educational Services (via multiple-choice surveys)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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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.
Samuel J Reiter, MD study director
Resident Ophthalmologist, CPMC
Taliva Martin, MD principal investigator
CPMC Ophthalmologist, Residency Program Director
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Complications and Diabetic Retinopathy, run by California Pacific Medical Center Research Institute.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Patient Knowledge about Diabetes at 3 months (via multiple-choice surveys) (time frame: Participants will be re-surveyed at their next follow-up eye appointment, an expected average of 3 months post-intervention). 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 27 Jul 2016.