Effectiveness Study of Occupational Therapy in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.

Detailed Description
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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.

Official Title
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Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Occupational Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: occupational therapy<br>10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease | Behavioral: Occupational Therapy<br>* 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.<br>|
| No Intervention: No occupational therapy<br>Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure (COPM) | Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceive Recall Plan Perform Measure (PRPP) | Observational measure. Activity performance patient | 3 months | 
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden.(caregiver) | 3 months | 
| Parkinson's Disease Questionnaire 39 (PDQ-39) | Health related Quality of life (Parkinson specific; patient) | 3 months | 
| Resource utilization questionnaire | For evaluating costs. (patient and caregiver) | 3 months | 
| Objective Caregiving Burden | Evaluating hours of care (costs). (caregiver) | 3 months | 
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 3 months | 
| The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) | Satisfaction with participation (patient) | 3 months | 
| Becks depression Inventory (BDI) | Mood and Depression. (patient) | 3 months | 
| Hospital Anxiety and Depression Scale (HADS) | Mood and depression. (caregiver). | 3 months | 
| The Utrecht Proactive Coping Competence list (UPCC) | Proactive coping skills. (patient and caregiver) | 3 months | 
| Fatigue Severity Scale (FSS) | Impact of fatigue (patient) | 3 months | 
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance. (patient) | 3 months | 
| Quality of life-overall | One question on rating overall quality of life (VAS scale). (patient and caregiver). | 3 months | 
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden. (caregiver) | 6 months | 
| Parkinson's Disease Questionnaire 39 (PDQ-39) | Health related Quality of life (Parkinson specific) | 6 months | 
| Objective Caregiving Burden | Evaluating hours of care (costs). (caregiver). | 6 months | 
| Euroqol EQ-5D | Quality of life. Used for patient and caregiver in evaluation of cost effectiveness | 6 months | 
| Canadian Occupational Performance Measure (COPM) | 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. | 6 months | 
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance. (patient) | 6 months | 
| The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) | Satisfaction with participation (patient) | 6 months | 
| Becks depression Inventory (BDI) | Mood and Depression. (patient) | 6 months | 
| Hospital Anxiety and Depression Scale (HADS) | Mood and depression. (caregiver). | 6 months | 
| The Utrecht Proactive Coping Competence list (UPCC) | Proactive coping skills. (patient and caregiver) | 6 months | 
| Fatigue Severity Scale (FSS) | Impact of fatigue (patient) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational Therapy, Parkinson's Disease, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden, Economic evaluation