Clinical trial NCT01336127: Effectiveness Study of Occupational Therapy in Parkinson's Disease
Official title: Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Occupational Therapy
Parkinson's Disease
Effectiveness
RCT
Activities of daily living
Participation
Caregiver's Burden
Economic evaluation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Princess Beatrix Muscle Foundation
First posted: 2011-04-15
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 3 months
Secondary outcomes:
measure: Perceive Recall Plan Perform Measure (PRPP)
timeFrame: 3 months
measure: Zarit Burden Inventory (ZBI)
timeFrame: 3 months
measure: Parkinson's Disease Questionnaire 39 (PDQ-39)
timeFrame: 3 months
measure: Resource utilization questionnaire
timeFrame: 3 months
measure: Objective Caregiving Burden
timeFrame: 3 months
measure: Activity Card Sort (ACS)
timeFrame: 3 months
measure: The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
timeFrame: 3 months
measure: Becks depression Inventory (BDI)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: The Utrecht Proactive Coping Competence list (UPCC)
timeFrame: 3 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 3 months
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
timeFrame: 3 months
measure: Quality of life-overall
timeFrame: 3 months
measure: Zarit Burden Inventory (ZBI)
timeFrame: 6 months
measure: Parkinson's Disease Questionnaire 39 (PDQ-39)
timeFrame: 6 months
measure: Objective Caregiving Burden
timeFrame: 6 months
measure: Euroqol EQ-5D
timeFrame: 6 months
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 6 months
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
timeFrame: 6 months
measure: The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
timeFrame: 6 months
measure: Becks depression Inventory (BDI)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: The Utrecht Proactive Coping Competence list (UPCC)
timeFrame: 6 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Blaricum
country: Netherlands
facility: Tergooiziekenhuizen
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Harderwijk
country: Netherlands
facility: St Jansdal
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Utrecht
country: Netherlands
facility: St. Antonius
city: Zeist
country: Netherlands
facility: Diakonessenhuis
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Radboud University Medical Center
name: Marten Munneke, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sturkenboom IH, Hendriks JC, Graff MJ, Adang EM, Munneke M, Nijhuis-van der Sanden MW, Bloem BR. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial. Mov Disord. 2015 Jul;30(8):1059-67. doi: 10.1002/mds.26217. Epub 2015 Apr 8.
citation: Sturkenboom IH, Graff MJ, Hendriks JC, Veenhuizen Y, Munneke M, Bloem BR, Nijhuis-van der Sanden MW; OTiP study group. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial. Lancet Neurol. 2014 Jun;13(6):557-66. doi: 10.1016/S1474-4422(14)70055-9. Epub 2014 Apr 8.
citation: Sturkenboom IH, Graff MJ, Borm GF, Adang EM, Nijhuis-van der Sanden MW, Bloem BR, Munneke M. Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2013 Feb 2;14:34. doi: 10.1186/1745-6215-14-34.