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

NCT03417583 | Completed

• 1 other identifier: 172030
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline to 18 months

Study Arms (2)

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.

Other: Protocol Intervention Group

Interventions

Protocol Intervention Group OTHER

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.

Protocol Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• years or older
• A caregiver will be defined as someone who lives with or has at least weekly contact with the HD patient

You may not qualify if:

• Patient participants:
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Isaacs

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Movement Disorder Fellow

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 31, 2018
• Study Start: November 9, 2018
• Primary Completion: January 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

US (1)