Effectiveness Study of Occupational Therapy in Parkinson's Disease

Parkinson's Disease Clinical Trial

— OTiP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336127
• Other study ID #: W.OR09-29
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: August 26, 2014
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Princess Beatrix Muscle Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Perceive Recall Plan Perform Measure (PRPP)	Observational measure. Activity performance patient	3 months	Yes
Secondary	Zarit Burden Inventory (ZBI)	Perceived caregiver burden.(caregiver)	3 months	No
Secondary	Parkinson's Disease Questionnaire 39 (PDQ-39)	Health related Quality of life (Parkinson specific; patient)	3 months	No
Secondary	Resource utilization questionnaire	For evaluating costs. (patient and caregiver)	3 months	No
Secondary	Objective Caregiving Burden	Evaluating hours of care (costs). (caregiver)	3 months	No
Secondary	Activity Card Sort (ACS)	Participation measure:% retained activities.(patient)	3 months	No
Secondary	The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)	Satisfaction with participation (patient)	3 months	No
Secondary	Becks depression Inventory (BDI)	Mood and Depression. (patient)	3 months	No
Secondary	Hospital Anxiety and Depression Scale (HADS)	Mood and depression. (caregiver).	3 months	No
Secondary	The Utrecht Proactive Coping Competence list (UPCC)	Proactive coping skills. (patient and caregiver)	3 months	No
Secondary	Fatigue Severity Scale (FSS)	Impact of fatigue (patient)	3 months	No
Secondary	Canadian Occupational Performance Measure (COPM-satisfaction)	Perceived satisfaction with performance. (patient)	3 months	No
Secondary	Quality of life-overall	One question on rating overall quality of life (VAS scale). (patient and caregiver).	3 months	No
Secondary	Zarit Burden Inventory (ZBI)	Perceived caregiver burden. (caregiver)	6 months	No
Secondary	Parkinson's Disease Questionnaire 39 (PDQ-39)	Health related Quality of life (Parkinson specific)	6 months	No
Secondary	Objective Caregiving Burden	Evaluating hours of care (costs). (caregiver).	6 months	No
Secondary	Euroqol EQ-5D	Quality of life. Used for patient and caregiver in evaluation of cost effectiveness	6 months	No
Secondary	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	No
Secondary	Canadian Occupational Performance Measure (COPM-satisfaction)	Perceived satisfaction with performance. (patient)	6 months	No
Secondary	The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)	Satisfaction with participation (patient)	6 months	No
Secondary	Becks depression Inventory (BDI)	Mood and Depression. (patient)	6 months	No
Secondary	Hospital Anxiety and Depression Scale (HADS)	Mood and depression. (caregiver).	6 months	No
Secondary	The Utrecht Proactive Coping Competence list (UPCC)	Proactive coping skills. (patient and caregiver)	6 months	No
Secondary	Fatigue Severity Scale (FSS)	Impact of fatigue (patient)	6 months	No