Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 301
- Locations
- 6
- Primary Endpoint
- Parkinson's Disease Quality of Life Questionnaire (PDQL)
Study Overview
Brief Summary
The aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. Overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD.
Detailed Description
PD is a complex disorder, with motor as well as non-motor symptoms. Despite the complexity of PD, management of the disease is often 'monodisciplinary' since most patients are only treated by a neurologist. Stimulating compensatory strategies by allied health professionals might offer additional therapeutic relief, but this assumption is mainly based on theoretical arguments and expert opinion. Even less is known about the claim that a multidisciplinary team of multiple professionals active in complementary domains (e.g. physiotherapy, occupational therapy and speech therapy) is superior to management by each of these professionals alone.
This study anticipates to provide more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD. Therefore, our multidisciplinary care concept (a comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by specifically trained health professionals) that is tailored to the patients' individual needs will be compared to usual care in terms of effectiveness and costs.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Idiopathic PD, diagnosed according to the Brain Bank Criteria of the UK Parkinson's Disease Society
- •Regular control by the neurologist
- •Living independently in the community
- •Able to complete the trial questionnaires
Exclusion Criteria
- •Atypical parkinsonian syndromes
- •Hoehn and Yahr stage 5
- •Severe cognitive impairment (MMSE<24)
- •Presence of other neurological disorders
- •Severe co-morbidity (e.g. cancer)
- •Planned surgical procedure for PD within the intervention period
- •Patients who have already visited the Multidisciplinary Assessment Center
Arms & Interventions
I
Multidisciplinary Care
Intervention: Multidisciplinary Care (Other)
II
Usual Care
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Parkinson's Disease Quality of Life Questionnaire (PDQL)
Time Frame: 8 months
AMC Linear Disability Score (ALDS)
Time Frame: 8 months
Secondary Outcomes
- SF-36 (secundary;utility score)(8 months)
- UPDRS Motor Examination (part III)(secondary)(4 months)
- UPDRS Complications of therapy (part IV)(tertiary)(4 months)
- SPDDS(tertiary)(8 months)
- Modified MACTAR scale(tertiary)(8 months)
- Parkinson Activity Scale(tertiary)(4 months)
- Costs (secondary)(8 months)
- Frequency of falls (tertiary)(8 months)
- Freezing of Gait Questionnaire (tertiary)(8 months)
- Falls Efficacy Scale (tertiary)(8 months)
- Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)(8 months (Quest) and 4 months (Scale))
- Hospital Anxiety and Depression Scale (tertiary)(8 months)
- Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)(8 months)