Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients

Huntington Disease Clinical Trial

Official title: Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

Psychiatric and Motor Symptom Assessment (This will take approximately 60 minutes):

• The Hamilton Anxiety Rating Scale (HAM-A) asks you to rate the severity of 14 anxiety symptoms.

• The Problem Behaviors Assessment short form (PBA-s) asks you and your caregiver about the frequency and severity of 11 different psychiatric symptoms that can be experienced in HD.

• The Columbia Suicide Severity Rating Scale includes up to 6 items yes or no questions to assess presence and severity of suicidal thoughts.

• The Montreal Cognitive Assessment (MOCA) is short test to measure your memory and thinking skills.

• The United Huntington's Disease Rating Scale (UHDRS) tool is used by HD clinicians to measure the presence and severity of your motor symptoms like chorea and walking difficulty.

• The UHDRS Total Functional Capacity (TFC) scale is used by HD clinicians to rate your ability to carry out daily tasks such as household chores or managing finances."

As presented to Phase B (protocol) 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. In addition, your psychiatric symptoms will be treated according to a systematic protocol developed by HD experts that guides treatment decisions based on our current clinical standard of care. You will return for in-person follow-up assessment 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.

Psychiatric and Motor Symptom Assessment (This will take approximately 60 minutes):

• The Hamilton Anxiety Rating Scale (HAM-A) asks you to rate the severity of 14 anxiety symptoms.

• The Problem Behaviors Assessment short form (PBA-s) asks you and your caregiver about the frequency and severity of 11 different psychiatric symptoms that can be experienced in HD.

• The Columbia Suicide Severity Rating Scale includes up to 6 items yes or no questions to assess presence and severity of suicidal thoughts.

• The Montreal Cognitive Assessment (MOCA) is short test to measure your memory and thinking skills.

• The United Huntington's Disease Rating Scale (UHDRS) tool is used by HD clinicians to measure the presence and severity of your motor symptoms like chorea and walking difficulty.

• The UHDRS Total Functional Capacity (TFC) scale is used by HD clinicians to rate your ability to carry out daily tasks such as household chores or managing finances."

As presented to caregiver participant:

"If you are involved in this study, you will be asked to assist the HD patient in completing a series of online surveys assessing his or her psychiatric symptoms and quality of life. You will also be asked to complete an online survey about your experience as a caregiver:

• The Traumatic Brain Injury- Care Quality of Life (TBI-CareQOL) Caregiver Strain short form includes 6 items which ask you to rate your feelings of stress and strain related to being a caregiver.

All surveys will be emailed to you the week prior to an in-person study visit.

You will then accompany the HD patient to clinic for an in-person assessment of psychiatric and motor symptoms of HD. During this visit you will be asked to answer questions about the patient's psychiatric symptoms (see scales below) and offer input on other symptom surveys directed to the patient as you would in a normal clinic visit.

• The Factor analysis of the frontal systems behavior scale (FrSBe) family-version is a 46-item scale that asks you to rate characteristics of frontal lobe dysfunction that you observe in the HD patient currently and prior to disease onset.

• The Problem Behaviors Assessment short form (PBA-s) asks you and the HD patient about the frequency and severity of 11 different psychiatric symptoms that can be experienced in HD. " ;

Related Conditions & MeSH terms

• Huntington Disease

• NCT number: NCT03417583
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Status: Completed
• Phase: N/A
• Start date: November 9, 2018
• Completion date: October 10, 2023