GlaucomaI-SIGHTNCT00794170

Interactive Study to Increase Glaucoma Adherence to Treatment

A study testing Telephone and Print based intervention in people with Glaucoma, run by Emory University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Glaucoma
What is being tested?: Telephone and Print based intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 312 participants
Where: 2 sitesUnited States
Study dates: Aug 2008to Sep 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition
Be between the ages of 18-80
Be Caucasian or African American
Possess a telephone (home telephone or cellular phone)
Speak and understand English
Be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year
Be prescribed daily doses of topical treatments for at least one year
Be able to read or have someone who can help the participant with reading written materials that we give to the participant

Who cannot join

Having eye surgery within 3 months of baseline interview and enrollment
Being legally blind (20/200 or worse)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Atlanta VA Medical Center
Atlanta, Georgia, 30033
Grady Health System
Atlanta, Georgia, 30303

Other trials in United States

About this study

Official title: I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation

Read the detailed description

The intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen. The intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. We evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months

Conditions: Glaucoma
Being tested: Telephone and Print based intervention
Keywords: Treatment Compliance
Medical subject headings: Glaucoma, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telephone and Print based interventionBehavioural
Thiss intervention consisted of tailored phone calls and follow-up mailings.

Study groups in NCT00794170
Study group	Role	What they receive
Telephone and print based intervention	Experimental	The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials. Receives: Behavioral: Telephone and Print based intervention
Usual care	No intervention	The control group received usual care at each clinical site and interacted with study personnel only for data collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.
Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Sep 2010

First posted19 Nov 2008 (estimated)
Study startAug 2008
Primary completionJun 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00794170
Sponsor's protocol ID: IRB00001335
Other IDs: R01EY016997, I-SIGHT
Acronym: I-SIGHT
Status last verified: May 2014
First submitted: 17 Nov 2008
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Glanz K, Beck AD, Bundy L, Primo S, Lynn MJ, Cleveland J, Wold JA, Echt KV. Impact of a health communication intervention to improve glaucoma treatment adherence. Results of the interactive study to increase glaucoma adherence to treatment trial. Arch Ophthalmol. 2012 Oct;130(10):1252-8. doi: 10.1001/archophthalmol.2012.1607.
PubMed 22688429

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation
ClinicalTrials.gov ID: NCT00794170
Acronym / sponsor ID: I-SIGHT / IRB00001335
Conditions: Glaucoma
Keywords: Treatment Compliance
Study type: Interventional
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Aug 2008
Primary completion: Jun 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 9 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Telephone and print based intervention	Experimental	Behavioral: Telephone and Print based interventionThe I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
Usual care	No intervention	–The control group received usual care at each clinical site and interacted with study personnel only for data collection.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition
Be between the ages of 18-80
Be Caucasian or African American
Possess a telephone (home telephone or cellular phone)
Speak and understand English

Key exclusion criteria (2 listed)

Having eye surgery within 3 months of baseline interview and enrollment
Being legally blind (20/200 or worse)

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
Telephone and Print based interventionThiss intervention consisted of tailored phone calls and follow-up mailings.	Behavioural	Telephone and print based intervention

Primary outcome

Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
Time frame: Baseline and 12 months
The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.

Results and safety

Results posted to the registry on 9 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telephone and Print Based Intervention	157	150
Usual Care	155	152

Primary outcome: Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)

Time frame: Baseline and 12 months. Number. Unit: participants

Measure	Telephone and Print Intervention n = 157	Usual Care n = 155
Value	150	152

Population analysed: The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telephone and Print Based Intervention	0 of 157 (0%)	0 of 157 (0%)	Not reported
Usual Care	0 of 155 (0%)	0 of 155 (0%)	Not reported

Limitations and caveats (from the sponsor): There may have been a selection bias that contributed to a placebo effect in the control group. The "control" patients may have already been motivated to seek knowledge or involvement in management of glaucoma.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22688429Glanz K, Beck AD, Bundy L, Primo S, Lynn MJ, Cleveland J, Wold JA, Echt KV. Impact of a health communication intervention to improve glaucoma treatment adherence. Results of the interactive study to increase glaucoma adherence to treatment trial. Arch Ophthalmol. 2012 Oct;130(10):1252-8. doi: 10.1001/archophthalmol.2012.1607.

Related trials for Glaucoma

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

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.

Karen Glanz, PhD, MPH principal investigator

Emory University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telephone and Print based intervention in people with Glaucoma, run by Emory University at 2 sites in United States.

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 8 inclusion and 2 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00794170, which also lists 1 linked publication.

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 9 Jun 2014.