Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)
研究概览
简要总结
The purpose of this study is to understand if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) that experience emotional distress related to participants' vision loss.
The study team hypothesize that treatment with LVR will produce measurable functional gains and that these effects will be enhanced by ERT-linked improvement among the subgroup of IRD patients with elevated vision-related anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The 6 and 12-month post-LVR assessments will be administered by a study team member that is masked to Arm assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with vision impairment with IRD etiology
- •Must have had a clinical exam with an IRD specialist within the three months of assignment to Arm
- •Have had a Goldmann visual field that was tested with III-4e isopter within the last year
- •Have a disability greater than zero theta in any of the domains of Michigan Retinal Dystrophy Questionnaire (MRDQ)
- •Have an indication from the IRD specialist that the ocular condition will not deteriorate over the next 1- year
- •Able to participate in 10 weeks of ERT sessions while being physically located in Michigan (these will take place in the first 10 months of the study)
排除标准
- •Having other ocular comorbidities including those associated with an IRD such as control of cystoid macular edema (CME)
- •Functional needs regarding low vision (i.e. activities of daily living) have been adequately addressed per a study low vision specialist
- •Current mental health therapy
- •The participant must not have an elevated suicidal intention (SI) or suicide risk based on Patient Health Questionnaire (PHQ-9) further information collected at screening (If suicidal intentions are identified, the study staff will complete the suicide protocol (per protocol)
- •If the participant is using medication for mental health or psychiatry concerns, participants must be on a stable dose of the medication (1-month of taking), otherwise will be excluded
- •Inability to complete study task requirements
结局指标
主要结局
Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)
时间窗: Baseline to 6 month
The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).
Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ)
时间窗: Baseline to 6 month
The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).
Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQ
时间窗: Baseline, 6 months
Comparison between low-distress arm and high-distress arm prior to ERT treatment at month-6. The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).
Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ
时间窗: Baseline, 6 months
Comparison between low-distress arm and high-distress arm prior to ERT treatment at month-6. The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).
Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by MVAQ
时间窗: Baseline, 6 months
The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).
Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by the MRDQ
时间窗: Baseline, 6 months
The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).
次要结局
- Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ)(6 months)
- Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9)(6 months)
- Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS)(6 months)
- Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36)(Baseline to 6 month)
- Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Penn State Worry Questionnaire (PSWQ)(6 months)
- Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Psychosocial Impact of Assistive Devices Scale (PIADS)(6 months)
- Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Generalized Anxiety Disorder (GAD)-7(6 months)
- Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Rumination-Reflection Questionnaire (RRQ)(6 months)
研究者
K. Thiran Jayasundera
Professor of Ophthalmology and Visual Sciences and Associate Chair
University of Michigan