An interventional study of Telephone and Print based intervention in Glaucoma, sponsored by Emory University. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Emory University · Not applicable and Interventional
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.
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
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 312 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Telephone and Print based intervention
The control group received usual care at each clinical site and interacted with study personnel only for data collection.
Thiss intervention consisted of tailored phone calls and follow-up mailings.
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.
Time frame: Baseline and 12 months
| Milestone | Telephone and Print Based Intervention | Usual Care |
|---|---|---|
| Started | 157 | 155 |
| Completed | 150 | 152 |
| Not completed | 7 | 3 |
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.
| participants | Telephone and Print Intervention | Usual Care |
|---|---|---|
| Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) | 150 | 152 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telephone and Print Based Intervention | — | 0/157 (0%) | 0/157 (0%) |
| Usual Care | — | 0/155 (0%) | 0/155 (0%) |
| Age, Categorical(Participants) | Telephone and Print Based Intervention | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 91 | 95 | 186 |
| >=65 years | 66 | 60 | 126 |
| Sex: Female, Male(Participants) | Telephone and Print Based Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 59 | 58 | 117 |
| Male | 98 | 97 | 195 |
| Region of Enrollment(participants) | Telephone and Print Based Intervention | Usual Care | Total |
|---|---|---|---|
| United States | 157 | 155 | 312 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University