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Effectiveness Study of Occupational Therapy in Parkinson's Disease (OTiP)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Occupational Therapy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Occupational Therapy, Parkinson's Disease, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden, Economic evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meander Medisch Centrum
  • Gelre Ziekenhuizen
  • Tergooiziekenhuizen
  • Deventer Ziekenhuis
  • St Jansdal
  • Tergooiziekenhuizen
  • St. Antonius
  • Diakonessenhuis
  • Gelre Ziekenhuizen
  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

occupational therapy

No occupational therapy

Arm Description

10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease

Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2011
Last Updated
August 26, 2014
Sponsor
Radboud University Medical Center
Collaborators
Princess Beatrix Muscle Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01336127
Brief Title
Effectiveness Study of Occupational Therapy in Parkinson's Disease
Acronym
OTiP
Official Title
Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Princess Beatrix Muscle Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Occupational Therapy, Parkinson's Disease, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden, Economic evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
occupational therapy
Arm Type
Experimental
Arm Description
10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease
Arm Title
No occupational therapy
Arm Type
No Intervention
Arm Description
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Perceive Recall Plan Perform Measure (PRPP)
Description
Observational measure. Activity performance patient
Time Frame
3 months
Title
Zarit Burden Inventory (ZBI)
Description
Perceived caregiver burden.(caregiver)
Time Frame
3 months
Title
Parkinson's Disease Questionnaire 39 (PDQ-39)
Description
Health related Quality of life (Parkinson specific; patient)
Time Frame
3 months
Title
Resource utilization questionnaire
Description
For evaluating costs. (patient and caregiver)
Time Frame
3 months
Title
Objective Caregiving Burden
Description
Evaluating hours of care (costs). (caregiver)
Time Frame
3 months
Title
Activity Card Sort (ACS)
Description
Participation measure:% retained activities.(patient)
Time Frame
3 months
Title
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
Description
Satisfaction with participation (patient)
Time Frame
3 months
Title
Becks depression Inventory (BDI)
Description
Mood and Depression. (patient)
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Mood and depression. (caregiver).
Time Frame
3 months
Title
The Utrecht Proactive Coping Competence list (UPCC)
Description
Proactive coping skills. (patient and caregiver)
Time Frame
3 months
Title
Fatigue Severity Scale (FSS)
Description
Impact of fatigue (patient)
Time Frame
3 months
Title
Canadian Occupational Performance Measure (COPM-satisfaction)
Description
Perceived satisfaction with performance. (patient)
Time Frame
3 months
Title
Quality of life-overall
Description
One question on rating overall quality of life (VAS scale). (patient and caregiver).
Time Frame
3 months
Title
Zarit Burden Inventory (ZBI)
Description
Perceived caregiver burden. (caregiver)
Time Frame
6 months
Title
Parkinson's Disease Questionnaire 39 (PDQ-39)
Description
Health related Quality of life (Parkinson specific)
Time Frame
6 months
Title
Objective Caregiving Burden
Description
Evaluating hours of care (costs). (caregiver).
Time Frame
6 months
Title
Euroqol EQ-5D
Description
Quality of life. Used for patient and caregiver in evaluation of cost effectiveness
Time Frame
6 months
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
6 months
Title
Canadian Occupational Performance Measure (COPM-satisfaction)
Description
Perceived satisfaction with performance. (patient)
Time Frame
6 months
Title
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
Description
Satisfaction with participation (patient)
Time Frame
6 months
Title
Becks depression Inventory (BDI)
Description
Mood and Depression. (patient)
Time Frame
6 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Mood and depression. (caregiver).
Time Frame
6 months
Title
The Utrecht Proactive Coping Competence list (UPCC)
Description
Proactive coping skills. (patient and caregiver)
Time Frame
6 months
Title
Fatigue Severity Scale (FSS)
Description
Impact of fatigue (patient)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, Phd
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meander Medisch Centrum
City
Amersfoort
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Blaricum
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
St Jansdal
City
Harderwijk
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Hilversum
Country
Netherlands
Facility Name
St. Antonius
City
Utrecht
Country
Netherlands
Facility Name
Diakonessenhuis
City
Zeist
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Zutphen
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25854809
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.
Results Reference
derived
PubMed Identifier
24726066
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. Erratum In: Lancet Neurol. 2014 Jun;13(6):536. Lancet Neurol. 2016 Mar;15(3):241. Lancet Neurol. 2016 Apr;15(4):352. Lancet Neurol. 2016 Mar;15(3):241.
Results Reference
derived
PubMed Identifier
23374761
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.
Results Reference
derived

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Effectiveness Study of Occupational Therapy in Parkinson's Disease

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