Effectiveness Study of Occupational Therapy in Parkinson's Disease (OTiP)
Recruitment status was Active, not recruiting
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Purpose
The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Behavioral: Occupational Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial |
- Canadian Occupational Performance Measure (COPM) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)
- Perceive Recall Plan Perform Measure (PRPP) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Observational measure. Activity performance patient
- Zarit Burden Inventory (ZBI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Perceived caregiver burden.(caregiver)
- Parkinson's Disease Questionnaire 39 (PDQ-39) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Health related Quality of life (Parkinson specific; patient)
- Resource utilization questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]For evaluating costs. (patient and caregiver)
- Objective Caregiving Burden [ Time Frame: 3 months ] [ Designated as safety issue: No ]Evaluating hours of care (costs). (caregiver)
- Activity Card Sort (ACS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Participation measure:% retained activities.(patient)
- The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Satisfaction with participation (patient)
- Becks depression Inventory (BDI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Mood and Depression. (patient)
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Mood and depression. (caregiver).
- The Utrecht Proactive Coping Competence list (UPCC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Proactive coping skills. (patient and caregiver)
- Fatigue Severity Scale (FSS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Impact of fatigue (patient)
- Canadian Occupational Performance Measure (COPM-satisfaction) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Perceived satisfaction with performance. (patient)
- Quality of life-overall [ Time Frame: 3 months ] [ Designated as safety issue: No ]One question on rating overall quality of life (VAS scale). (patient and caregiver).
- Zarit Burden Inventory (ZBI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Perceived caregiver burden. (caregiver)
- Parkinson's Disease Questionnaire 39 (PDQ-39) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Health related Quality of life (Parkinson specific)
- Objective Caregiving Burden [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluating hours of care (costs). (caregiver).
- Euroqol EQ-5D [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quality of life. Used for patient and caregiver in evaluation of cost effectiveness
- Canadian Occupational Performance Measure (COPM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Canadian Occupational Performance Measure (COPM-satisfaction) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Perceived satisfaction with performance. (patient)
- The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Satisfaction with participation (patient)
- Becks depression Inventory (BDI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mood and Depression. (patient)
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mood and depression. (caregiver).
- The Utrecht Proactive Coping Competence list (UPCC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Proactive coping skills. (patient and caregiver)
- Fatigue Severity Scale (FSS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Impact of fatigue (patient)
| Estimated Enrollment: | 192 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: occupational therapy
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
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.
|
|
No Intervention: No occupational therapy
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Netherlands | |
| Meander Medisch Centrum | |
| Amersfoort, Netherlands | |
| Gelre Ziekenhuizen | |
| Apeldoorn, Netherlands | |
| Tergooiziekenhuizen | |
| Blaricum, Netherlands | |
| Deventer Ziekenhuis | |
| Deventer, Netherlands | |
| St Jansdal | |
| Harderwijk, Netherlands | |
| Tergooiziekenhuizen | |
| Hilversum, Netherlands | |
| St. Antonius | |
| Utrecht, Netherlands | |
| Diakonessenhuis | |
| Zeist, Netherlands | |
| Gelre Ziekenhuizen | |
| Zutphen, Netherlands | |
| Isala Klinieken | |
| Zwolle, Netherlands | |
| Principal Investigator: | Marten Munneke, Phd | Radboud University Medical Centre |
More Information
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01336127 History of Changes |
| Other Study ID Numbers: | W.OR09-29 |
| Study First Received: | March 17, 2011 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Occupational Therapy Parkinson's Disease Effectiveness RCT |
Activities of daily living Participation Caregiver's Burden Economic evaluation |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on June 18, 2013