Huntington DiseaseNCT03417583
Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients
A study testing Protocol Intervention Group in people with Huntington Disease, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Protocol Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed 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. "
- Conditions
- Huntington Disease
- Being tested
- Protocol Intervention Group
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol Intervention GroupOther
For neuropsychiatric symptoms identified by the clinician, the treatment protocol, based on clinical standard of care, will be implemented. This protocol includes directions for multidisciplinary treatment of 7 neuropsychiatric symptoms: depression, apathy, anxiety, agitation/irritability, obsessive compulsive behaviors, delusions/hallucinations, and sleep dysfunction. These treatment recommendations differ according to symptom but include provision of additional information to patients and caregivers, psychotherapy/counseling, and pharmacotherapeutic treatment options including recommended agents and follow-up schedule.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Standard Care Group | No intervention | These patients will continue to be seen by their regular neurology provider for Huntington's disease. They will not be treated explicitly according to the protocol, though they may be prescribed some of the same medications. |
| Protocol Intervention Group | Experimental | These participants will transfer their clinical care to the study provider for the duration of the study, and their symptom treatment will be guided by the study protocol. Receives: Other: Protocol Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life- Concern with Death and Dying
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.
Measured: Baseline to 18 months
Change in quality of life- Meaning and Purpose
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.
Measured: Baseline to 18 months
Change in quality of life- Ability to Participate in Social Roles and Activities
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.
Measured: Baseline to 18 months
Change in quality of life- Anxiety
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.
Measured: Baseline to 18 months
Change in quality of life- Depression
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.
Measured: Baseline to 18 months
Change in quality of life- Positive Affect and Well-Being
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.
Measured: Baseline to 18 months
Change in quality of life- Satisfaction with Social Roles and Activities
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.
Measured: Baseline to 18 months
Change in quality of life- Caregiver Strain
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.
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start9 Nov 2018
- Primary completion10 Jan 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, David Isaacs, Vanderbilt University Medical Center
- Investigators
- David Isaacs, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417583
- Sponsor's protocol ID
- 172030
- Status last verified
- Nov 2023
- First submitted
- 23 Jan 2018
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Neuropsychiatric Assessment and Treatment Protocols in Huntington's Disease Patients
- ClinicalTrials.gov ID
- NCT03417583
- Acronym / sponsor ID
- 172030
- Conditions
- Huntington Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. "
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Standard Care Group | No intervention | –These patients will continue to be seen by their regular neurology provider for Huntington's disease. They will not be treated explicitly according to the protocol, though they may be prescribed some of the same medications. |
| Protocol Intervention Group | Experimental | Other: Protocol Intervention GroupThese participants will transfer their clinical care to the study provider for the duration of the study, and their symptom treatment will be guided by the study protocol. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 18 years or older
Key exclusion criteria (7 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol Intervention GroupFor neuropsychiatric symptoms identified by the clinician, the treatment protocol, based on clinical standard of care, will be implemented. This protocol includes directions for multidisciplinary treatment of 7 neuropsychiatric symptoms: depression, apathy, anxiety, agitation/irritability, obsessive compulsive behaviors, delusions/hallucinations, and sleep dysfunction. These treatment recommendations differ according to symptom but include provision of additional information to patients and caregivers, psychotherapy/counseling, and pharmacotherapeutic treatment options including recommended agents and follow-up schedule. | Other | Protocol Intervention Group |
Primary outcome
Change in quality of life- Concern with Death and Dying
Time frame: 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- Meaning and Purpose
Time frame: 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- Ability to Participate in Social Roles and Activities
Time frame: 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
Time frame: 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- Depression
Time frame: 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- Positive Affect and Well-Being
Time frame: 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- Satisfaction with Social Roles and Activities
Time frame: 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.
Change in quality of life- Caregiver Strain
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Isaacs principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol Intervention Group in people with Huntington Disease, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life- Concern with Death and Dying (time frame: Baseline to 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.