I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Having eye surgery within 3 months of baseline interview and enrollment
- •Being legally blind (20/200 or worse)
研究组 & 干预措施
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 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.
干预措施: Telephone and Print based intervention (Behavioral)
Usual care
The control group received usual care at each clinical site and interacted with study personnel only for data collection.
结局指标
主要结局
Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
时间窗: 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.
次要结局
未报告次要终点
研究者
Karen Glanz, MD
Adjunct Professor of Public Health
Emory University