Parkinson's Disease
Conditions
Keywords
Occupational Therapy, Parkinson's Disease, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden, Economic evaluation
Brief summary
The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.
Detailed description
Parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients. Occupational Therapy aims to optimise functional performance and engagement in meaningful roles and activities. The lack of scientific evidence for the effectiveness of Occupational Therapy (OT) in Parkinson's Disease (PD) highlights the urgent need for high quality intervention studies. The Dutch clinical practice guideline for OT in PD (2008)offers a good basis for conducting an intervention study. The completed OTiP pilot underscored the feasibility and the need for a large scale trial. The OTiP study evaluates the effectiveness of OT in improving daily functioning of patients with PD.
Interventions
BEHAVIORALOccupational Therapy
Patients in the experimental group will receive 10 weeks (maximum 16 hours) occupational therapy according to a treatment protocol, which is based on the Dutch evidence based guideline for occupational therapy in Parkinson's Disease and refined for this study.
Sponsors
Princess Beatrix Muscle Foundation
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients: * Idiopathic Parkinson's Disease * Indication for referral to occupational therapy * Home dwelling Inclusion criteria caregivers * Available for informal support minimal two times a week to a patient who participates in the study * Available to take part in the intervention
Exclusion criteria
* Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems\_MMSE score \< 24). * Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease. * Current participation in other allied health research (i.e. PARKFIT) * Having received occupational therapy intervention in the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) | 3 months | Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Inventory (ZBI) | 3 months | Perceived caregiver burden.(caregiver) |
| Parkinson's Disease Questionnaire 39 (PDQ-39) | 3 months | Health related Quality of life (Parkinson specific; patient) |
| Resource utilization questionnaire | 3 months | For evaluating costs. (patient and caregiver) |
| Objective Caregiving Burden | 3 months | Evaluating hours of care (costs). (caregiver) |
| Activity Card Sort (ACS) | 3 months | Participation measure:% retained activities.(patient) |
| The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) | 3 months | Satisfaction with participation (patient) |
| Becks depression Inventory (BDI) | 3 months | Mood and Depression. (patient) |
| Perceive Recall Plan Perform Measure (PRPP) | 3 months | Observational measure. Activity performance patient |
| The Utrecht Proactive Coping Competence list (UPCC) | 3 months | Proactive coping skills. (patient and caregiver) |
| Fatigue Severity Scale (FSS) | 3 months | Impact of fatigue (patient) |
| Canadian Occupational Performance Measure (COPM-satisfaction) | 3 months | Perceived satisfaction with performance. (patient) |
| Quality of life-overall | 3 months | One question on rating overall quality of life (VAS scale). (patient and caregiver). |
| Euroqol EQ-5D | 6 months | Quality of life. Used for patient and caregiver in evaluation of cost effectiveness |
| Canadian Occupational Performance Measure (COPM) | 6 months | Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 months (follow up) wil be used in a secondary analysis and analysis of cost effectiveness. |
| Hospital Anxiety and Depression Scale (HADS) | 3 months | Mood and depression. (caregiver). |
Countries
Netherlands
Outcome results
None listed