Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in quality of life- Depression
研究概览
简要总结
Phase A: Recruit 50 patients with HD, and their caregivers, to complete a neuropsychiatric and quality of life battery of scales at baseline. Have these 50 patients complete a formal psychiatric assessment with a psychiatrist within 2 weeks of this clinical battery, and the results of these 2 types of assessments will be compared to establish the level of agreement between clinical rating scales and formal psychiatric assessment.
Phase B: Continue to follow Phase A cohort longitudinally and administer neuropsychiatric and quality of life battery at 6 months, 12 months, and 18 months form baseline. Recruit an additional 50 patients, administer the same neuropsychiatric and quality of life battery at baseline, implement medication and counseling intervention according to a standard of care protocol, and follow up with the same neuropsychiatric and quality of life battery at 6, 12, and 18 months.
详细描述
As presented to Phase A (control) patient participant:
"If you are in this study, you will be asked to answer a series of online surveys assessing your psychiatric symptoms and quality of life in the presence of a caregiver. These surveys will be emailed to your consented caregiver in the week before your in-person visit. You will then come to clinic for an in-person assessment of psychiatric and motor symptoms of HD. You will also undergo an in-person psychiatric evaluation with a psychiatrist at Vanderbilt who works with HD patients. This psychiatric evaluation will take approximately 60 minutes and will occur up to 2 weeks before or after your first regular study visit. This involves a clinical interview during which a psychiatrist, who is an expert in psychiatric symptoms of HD, will ask about your experience with many different symptoms that can be experienced in HD. These two in-person evaluations will occur within 2 weeks of each other. You will continue to see your neurology provider for routine follow-up, and you will return for in-person follow-up assessments at 6 months, 12 months, and 18 months, repeating the online surveys prior to each visit.
Health-Related Quality of Life and Psychiatric Symptom Surveys (This will take approximately 60-90 minutes):
You will be asked to answer on-line survey questions about your psychiatric symptoms and quality of life in the presence of a caregiver.
- The Neuro-QoL scales include 4 subscales created specifically to measure quality of life in patients with neurological disease. These scales include 33 total questions which ask you to report your anxiety, depression, sense of well-being, and satisfaction with social roles within the previous week.
- The PROMIS Anger scale includes 8 questions that ask you to rate your symptoms of anger in the previous week.
- The PROMIS Sleep-Related Impairment short form includes 8 questions that ask about your sleep quality and how you feel during the day after sleeping.
- The Patient Health Questionnaire- 9 (PHQ-9) includes 9 questions about symptoms of depression that you may be experiencing and how these affect you on a daily basis.
- The HD Anosognosia Rating Scale includes 8 questions that ask you to assess how you perform daily tasks compared to other people of your same age and education level.
- Sleep Questionnaire includes 5 questions about your night and daytime sleep habits.
- We will also gather background information such as: date of birth, where you live, if you have insurance, and your income. You will also be asked about health and medical history such as: when you were diagnosed with HD and what medications you are taking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient participants:
- •Diagnosed with HD, either through genetic testing or neurologist's clinical diagnosis
- •Patient has at least 1 neuropsychiatric symptom, as reported by their HD provider
- •21 and older will be included, as symptoms of Juvenile HD (in patients 20 years old or less) can present differently
- •Presence of an eligible caregiver who can also participate in the study with them because several of the study measures require caregiver report
- •Caregivers:
- •18 years or older
- •A caregiver will be defined as someone who lives with or has at least weekly contact with the HD patient
排除标准
- •Patient participants:
- •20 years old or younger
- •Greater than moderate impairment on dementia screening
- •Lack of a caregiver to provide collateral information and complete caregiver assessments will also be excluded
- •Caregivers:
- •Younger than 18 years old and/or have less than weekly contact with the HD patient
- •Clinical impression of incompetency to answer survey questions as determined by the Jessie Sellers, Nurse Practitioner, or the neurologist caring for the HD patient, then he or she will not be eligible to participate.
结局指标
主要结局
Change in quality of life- Depression
时间窗: Baseline to 18 months
This is measured using the NeuroQoL- Depression scale, which measures depression in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of depression.
Change in quality of life- Concern with Death and Dying
时间窗: Baseline to 18 months
This is measured using the HDQLIFE Concern with Death and Dying scale, which measures concern with death and dying in Huntington's disease patients. The total score will range from 6 to 30, with higher scores indicating greater concern with death and dying.
Change in quality of life- Ability to Participate in Social Roles and Activities
时间窗: Baseline to 18 months
This is measured using the NeuroQoL- Ability to Participate in Social Roles and Activities scale, which measures ability of individuals with neurological conditions to participate in social roles and activities. The total score will range from 8 to 40, with higher scores indicating greater ability to participate in social roles and activities.
Change in quality of life- Anxiety
时间窗: Baseline to 18 months
This is measured using the NeuroQoL- Anxiety scale, which measures anxiety in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of anxiety.
Change in quality of life- Meaning and Purpose
时间窗: Baseline to 18 months
This is measured using HDQLIFE Meaning and Purpose scale, which measures feelings of meaning and purpose in Huntington's disease patients. The total score will range from 4 to 20, with higher scores indicating greater feelings of meaning and purpose in life.
Change in quality of life- Positive Affect and Well-Being
时间窗: Baseline to 18 months
This is measured using the NeuroQoL- Positive Affect and Well-Being scale, which measures positive affect and sense of well-being in individuals with neurological conditions. The total score will range from 9 to 45, with higher scores indicating a greater sense of well-being.
Change in quality of life- Caregiver Strain
时间窗: Baseline to 18 months
This is measured using the TBI-CareQoL- Caregiver Strain scale, which measures health related quality of life in caregivers. The total score will range from 6 to 30, with higher scores indicating greater levels of caregiver strain.
Change in quality of life- Satisfaction with Social Roles and Activities
时间窗: Baseline to 18 months
This is measured using the NeuroQoL- Satisfaction with Social Roles and Activities scale, which measures satisfaction with social roles and activities in individuals with neurological conditions. The total score will range from 8 to 40, with higher scores indicating greater levels of satisfaction with social roles and activities.
次要结局
未报告次要终点
研究者
David Isaacs
Movement Disorder Fellow
Vanderbilt University Medical Center