Overview
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clinical_trials_integrated_man["Integrated Management of Atypical Parkinsonism -"]
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clinical_trials_inte_0["Study Details"]
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clinical_trials_inte_1["Disease Conditions Studied"]
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clinical_trials_inte_2["Scientific Rationale"]
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clinical_trials_inte_3["Challenges in Atypical Parkinsonian Syndromes"]
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clinical_trials_inte_4["Care Challenges"]
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clinical_trials_inte_5["Integrated Care Models"]
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...Overview
Mermaid diagram (expand to render)
This study evaluates a comprehensive, patient-centered home-based care management program for patients with atypical Parkinsonian syndromes, focusing on improving quality of life, reducing hospitalizations, and optimizing functional independence["@nct"]. Atypical Parkinsonian syndromes (APS) represent a group of neurodegenerative disorders that share features with [Parkinson's Disease](/diseases/parkinsons-disease) but typically progress more rapidly and respond less favorably to dopaminergic medications["PSP_nih"].
The trial addresses a critical gap in neurological care: while significant research focuses on disease-modifying therapies, there remains a substantial unmet need in optimizing day-to-day management of patients with progressive neurodegnerative conditions. The integrated care model recognizes that comprehensive support services can significantly impact patient outcomes even in the absence of curative treatments.
Study Details
| Field | Value |
|-------|-------|
| NCT ID | NCT05792332 |
| Status | Recruiting |
| Study Type | Interventional |
| Study Design | Parallel assignment, single-blind |
| Conditions | PSP, MSA, CBS, Atypical Parkinsonism |
| Intervention | Home-based comprehensive care management |
| Age Range | 18 years and older |
| Enrollment | Target enrollment specified in trial registry |
| Primary Sponsor | Academic medical center |
Disease Conditions Studied
Progressive Supranuclear Palsy (PSP)
[PSP](/diseases/progressive-supranuclear-palsy) is a rare neurodegenerative disorder characterized by:
- Vertical gaze palsy — difficulty moving eyes vertically
- Postural instability — early and frequent falls
- Parkinsonism — bradykinesia, rigidity
- Cognitive decline — frontal lobe dysfunction
Richardson syndrome (classic PSP) accounts for approximately 70% of cases, with other variants including:
- PSP with parkinsonism (PSP-P)
- PSP with pure akinesia and gait freezing (PSP-PAGF)
- PSP with corticobasal syndrome (PSP-CBS)
The Richardson variant typically progresses more rapidly, with patients often requiring mobility aids within 3-4 years of onset and nursing home placement within 5-7 years[@psp_nih].
Multiple System Atrophy (MSA)
[MSA](/diseases/multiple-system-atrophy) encompasses two main subtypes:
- MSA-P (predominantly parkinsonian): Features include parkinsonism, autonomic dysfunction
- MSA-C (predominantly cerebellar): Features include ataxia, cerebellar signs
Key distinguishing features include:
- Autonomic failure — orthostatic hypotension, urinary dysfunction
- Cerebellar signs — gait ataxia, nystagmus
- Parkinsonism — poor levodopa response
- Rapid progression — typically 5-9 years from onset to death
Approximately 55% of cases present as MSA-P and 45% as MSA-C, with autonomic dysfunction being a defining feature[@msa_Overview].
Corticobasal Syndrome (CBS)
[CBS](/diseases/corticobasal-syndrome) represents a heterogeneous disorder with:
- Asymmetric parkinsonism — typically affects one side initially
- Cortical sensory loss — astereognosis, neglect
- Apraxia — difficulty with learned motor tasks
- Alien limb phenomena — involuntary limb movements
- Cognitive decline — progressive aphasia, executive dysfunction
CBS can arise from multiple underlying pathologies including corticobasal degeneration, progressive supranuclear palsy, Alzheimer's disease, and frontotemporal lobar degeneration, making accurate diagnosis challenging[cbs_Overview].
Scientific Rationale
Challenges in Atypical Parkinsonian Syndromes
Atypical Parkinsonian syndromes (APS) present unique challenges that differ substantially from [Parkinson's Disease](/diseases/parkinsons-disease)[@psp_nih][@msa_Overview][@cbs_Overview]:
Disease Progression
- Rapid progression: Mean survival 5-8 years from diagnosis, versus 15-20 years in PD
- Early disability: Loss of ambulation typically occurs within 3-5 years
- Multisystem involvement: Motor, autonomic, cognitive, and behavioral symptoms
Treatment Limitations
- Poor medication response: Limited benefit from levodopa compared to PD
- Complex regimens: Multiple medications for various symptoms
- Adverse effects: Sensitivity to medications, particularly antipsychotics
Care Needs
- Complex care coordination: Multiple specialists (neurology, cardiology, urology, psychiatry)
- Equipment needs: Mobility aids, communication devices, home modifications
- 24-hour supervision: Progressive need for caregiver assistance
Care Challenges
The comprehensive care model addresses multiple challenges[integrated_care_neuro][caregiver_burden]:
Complex medication regimens
- Multiple daily medications for motor and non-motor symptoms
- Timing dependencies (levodopa dosing intervals)
- Drug interactions requiring careful management
- Financial burden of multiple medications
Multiple specialist appointments
- Coordination across multiple healthcare systems
- Transportation challenges as disease progresses
- Communication between providers
- Appointment scheduling complexity
Progressive functional decline
- Loss of independence in activities of daily living
- Fall risk increasing with disease progression
- Communication difficulties
- Swallowing and nutrition challenges
High caregiver burden
- Physical demands of assistance with daily activities
- Emotional and psychological stress
- Financial burden of care-related costs
- Social isolation and role changes
Risk of institutionalization
- Caregiver burnout leading to nursing home placement
- Medical crises requiring hospitalization
- Safety concerns at home
- Financial considerations
Integrated Care Models
Evidence supports the efficacy of integrated care approaches[integrated_care_neuro][telehealth_neuro]:
Coordination across disciplines
- Multidisciplinary team approach
- Unified care planning
- Shared decision-making
Home-based interventions
- In-home therapy services
- Environmental modifications
- Personalized care plans
Telehealth monitoring
- Remote symptom tracking
- Medication adherence support
- Virtual check-ins
Caregiver support
- Education and training
- Respite services
- Support groups
Proactive problem-solving
- Anticipatory guidance
- Early intervention for complications
- Advance care planning
Study Objectives
Primary Endpoints
The trial measures several key outcomes:
Quality of life measures
- PDQ-39 (Parkinson's Disease Questionnaire-39)
- Caregiver burden scales (Zarit Burden Interview)
- Health utility measures
Healthcare utilization
- Hospitalization rates and frequency
- Emergency department visits
- Outpatient visit patterns
Safety outcomes
- Falls frequency and severity
- Time to first fall
- Fall-related injuries
Treatment adherence
- Medication compliance rates
- Appointment attendance
- Protocol adherence
Secondary Endpoints
Secondary outcomes include[home_rehab][fall_prevention]:
Functional independence
- ADL (Activities of Daily Living) scores
- IADL (Instrumental ADL) measures
- Functional Independence Measure (FIM)
Care trajectory
- Time to institutionalization
- Progression to wheelchair dependence
- Development of new complications
Patient and caregiver satisfaction
- Satisfaction questionnaires
- Quality of care measures
- Care experience ratings
Health economics
- Cost-effectiveness analysis
- Healthcare cost comparison
- Resource utilization patterns
Intervention Components
1. Care Coordination
The care coordination component provides[@integrated_care_neuro]:
- Dedicated care manager
- Single point of contact for all care needs
- Navigation assistance through healthcare system
- Advocacy for patient and family
- Regular phone/video check-ins
- Weekly scheduled touchpoints
- As-needed support between scheduled calls
- 24/7 availability for urgent concerns
- Medication reconciliation
- Regular review of all medications
- Identification of interactions
- Optimization of dosing schedules
- Cost-containment strategies
- Appointment scheduling
- Coordination of specialist appointments
- Transportation arrangements
- Pre-visit preparation
2. Home Safety Assessment
Home safety interventions include[@home_rehab][fall_prevention]:
- Fall risk evaluation
- Comprehensive home safety audit
- Identification of environmental hazards
- Balance and gait assessment
- Home modification recommendations
- Bathroom modifications (grab bars, shower chairs)
- Lighting improvements
- Furniture arrangement optimization
- Floor surface management
- Assistive device provision
- Walkers, wheelchairs, transfer devices
- Communication aids
- Adaptive equipment for daily activities
- Caregiver training
- Safe transfer techniques
- Fall prevention strategies
- Emergency response procedures
3. Telehealth Monitoring
Technology-enabled monitoring provides[telehealth_neuro]:
- Vital sign tracking
- Blood pressure monitoring (critical for MSA)
- Heart rate variability
- Weight monitoring
- Symptom reporting
- Motor symptom tracking
- Non-motor symptom logs
- Side effect documentation
- Medication reminders
- Automated dosing reminders
- Refill notifications
- Compliance tracking
- Exercise compliance
- Home exercise program monitoring
- Physical therapy adherence
- Daily activity tracking
4. Education and Support
Patient and caregiver education covers:
- Disease education
- Understanding disease progression
- Symptom management strategies
- Medication knowledge
- Coping strategies
- Behavioral management techniques
- Stress reduction methods
- Communication strategies
- Advance care planning
- Goals of care discussions
- Advance directive completion
- Legal planning (power of attorney, living will)
- Support groups
- Patient support groups
- Caregiver support networks
- Community resources
Disease-Specific Considerations
Relevance to PSP
[PSP](/diseases/progressive-supranuclear-palsy) patients particularly benefit from integrated care because[psp_nih]:
- Early falls require immediate home safety interventions
- Environmental modifications prevent injuries
- Mobility aids preserve independence
- Caregiver training enables safe assistance
- Progressive disability needs anticipatory planning
- Equipment needs evolve as disease progresses
- Care needs increase over time
- Financial planning addresses long-term needs
- Cognitive changes affect treatment adherence
- Caregiver involvement ensures compliance
- Simplified medication regimens improve adherence
- Regular monitoring identifies issues early
- Caregiver support is essential
- High burden requires proactive support
- Respite prevents burnout
- Education improves care quality
Relevance to MSA
[MSA](/diseases/multiple-system-atrophy) patients benefit from[msa_Overview]:
- Autonomic management
- Blood pressure monitoring and management
- Urinary catheter care if needed
- Swallowing assessment
- Cardiovascular protection
- Fluid and salt intake protocols
- Compression garment use
- Graduated position changes
- Respiratory monitoring
- Sleep-disordered breathing assessment
- Pneumonia prevention
- Early intervention for complications
Relevance to CBS
[CBS](/diseases/corticobasal-syndrome) patients require[cbs_Overview]:
- Asymmetric care needs
- Equipment adapted to affected side
- Environmental modifications for unilateral deficits
- Communication support
- Augmentative communication devices
- Speech therapy integration
- Cognitive support
- Structured daily routines
- Environmental cues
- Behavioral management strategies
Expected Outcomes
The integrated care model anticipates[integrated_care_neuro][caregiver_burden]:
Reduced healthcare utilization
- Fewer emergency department visits
- Reduced hospitalization rates
- Shorter hospital stays when required
Improved quality of life
- Better symptom management
- Enhanced functional independence
- Improved psychological well-being
Delayed institutionalization
- Extended time at home
- Reduced nursing home placement
- Caregiver sustainability improved
Reduced caregiver burden
- Improved coping skills
- Better support systems
- Enhanced quality of life
Cost savings
- Reduced healthcare costs
- Delayed long-term care expenses
- Optimized resource utilization
Comparison with Standard Care
| Outcome | Standard Care | Integrated Care |
|---------|--------------|-----------------|
| Annual hospitalizations | 2-3 per year | Expected reduction |
| Fall rate | 60-70% annually | Expected reduction |
| Time to nursing home | 3-5 years | Expected extension |
| Caregiver burden | High | Moderate |
| Quality of life | Variable | Expected improvement |
Implementation Considerations
Staff Requirements
- Care coordinators (1:30 patient ratio)
- Physical therapists for home assessments
- Telehealth support staff
- Administrative support
Technology Requirements
- Video conferencing platform (HIPAA-compliant)
- Remote monitoring devices
- Electronic health record integration
- Patient portal access
Cost Considerations
- Initial investment in infrastructure
- Staff training and development
- Ongoing operational costs
- Reimbursement models
Future Directions
This trial will inform:
Policy development for APS care standards
Reimbursement models for integrated care
Quality measures for neurological care
Care pathway development for APS managementCross-References
- [Progressive Supranuclear Palsy](/diseases/progressive-supranuclear-palsy)
- [Multiple System Atrophy](/diseases/multiple-system-atrophy)
- [Corticobasal Syndrome](/diseases/corticobasal-syndrome)
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [PSP Quality of Life](/diseases/psp-quality-of-life)
- [Caregiver Support in Neurodegeneration](/diseases/caregiver-burden-corticobasal-syndrome)](/diseases/neurodegeneration)
- [Home-Based Rehabilitation](/therapeutics/home-based-rehabilitation)](/therapeutics)
- [Fall Prevention in PSP](/diseases/falls-in-psp)
- [Telehealth in Movement Disorders](/therapeutics/telehealth-parkinsons)
Clinical Trials
- [PSP Clinical Trials Overview](/clinical-trials/psp-clinical-trials)](/clinical-trials)
- [MSA Clinical Trials Overview](/clinical-trials/msa-clinical-trials)](/clinical-trials)
- [CBS Clinical Trials Overview](/clinical-trials/cbs-clinical-trials)
References
[Unknown, NCT05792332 - Integrated Management of Atypical Parkinsonism: A Home-based Patient-Centered Approach (n.d.)](https://clinicaltrials.gov/study/NCT05792332)
[Unknown, Progressive Supranuclear Palsy - NINDS (n.d.)](https://www.ninds.nih.gov/health-information/disorders/progressive-supranuclear-palsy)
[Unknown, Multiple System Atrophy - NINDS (n.d.)](https://www.ninds.nih.gov/health-information/disorders/multiple-system-atrophy)
[Unknown, Corticobasal Syndrome - NINDS (n.d.)](https://www.ninds.nih.gov/health-information/disorders/corticobasal-degeneration)
[Unknown, Integrated care models for neurodegenerative diseases (n.d.)](https://pubmed.ncbi.nlm.nih.gov/)
[Unknown, Caregiver burden in atypical parkinsonism (n.d.)](https://pubmed.ncbi.nlm.nih.gov/)
[Unknown, Home-based rehabilitation in movement disorders (n.d.)](https://pubmed.ncbi.nlm.nih.gov/)
[Unknown, Fall prevention in parkinsonian syndromes (n.d.)](https://pubmed.ncbi.nlm.nih.gov/)
[Unknown, Telehealth in neurodegenerative disease management (n.d.)](https://pubmed.ncbi.nlm.nih.gov/)