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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY016997 | U.S. NIH Grant/Contract | View source | |
| I-SIGHT | Other Identifier | Other |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | No Intervention | The control group received usual care at each clinical site and interacted with study personnel only for data collection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone and Print based intervention | Behavioral | Thiss intervention consisted of tailored phone calls and follow-up mailings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Glanz, PhD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical Center | Atlanta | Georgia | 30033 | United States | ||
| Grady Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22688429 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telephone and Print Based Intervention | 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 objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. 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. |
| FG001 | Usual Care | The control group receives usual care at each clinical site and interacts with study personnel only for data collection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telephone and Print Based Intervention | This was a tailored phone call followed up by print materials. |
| BG001 | Usual Care | control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | participants | Baseline and 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telephone and Print Based Intervention |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Glanz | University of Pennsylvania | 215-898-0613 | kglanz@upenn.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| Atlanta |
| Georgia |
| 30303 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 157 |
| 0 |
| 157 |
| EG001 | Usual Care | 0 | 155 | 0 | 155 |
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| D015438 | Health Behavior |
| D001519 | Behavior |