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

This study has been completed.
Sponsor:
Collaborator:
Prinses Beatrix Spierfonds
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01336127
First received: March 17, 2011
Last updated: August 26, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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)


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)


Enrollment: 191
Study Start Date: April 2011
Study Completion Date: June 2013
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336127

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
Sponsors and Collaborators
Radboud University
Prinses Beatrix Spierfonds
Investigators
Principal Investigator: Marten Munneke, Phd Radboud University
  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: August 26, 2014
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 September 14, 2014