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

March 17, 2011
August 26, 2014
April 2011
February 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01336127 on ClinicalTrials.gov Archive Site
  • 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)
  • Perceive Recall Plan Perform Measure (PRPP) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Observational measure. Activity performance.
  • Zarit Burden Inventory (ZBI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Perceived caregiver burden. Used for caregiver.
  • Parkinson's Disease Questionnaire 39 (PDQ-39) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Health related Quality of life (Parkinson specific)
  • Resource utilization questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    For evaluating costs. Used for patient and caregiver.
  • Objective Caregiving Burden [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluating hours of care (costs). Used for 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
  • Activity Card Sort (ACS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Participation measure:%retained activities
  • The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Satisfaction with participation
  • Becks depression Inventory (BDI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mood and Depression. Used for patient
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mood and depression. Used for caregiver.
  • The Utrecht Proactive Coping Competence list (UPCC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proactive coping skills. Used for patient and caregiver
  • Fatigue Severity Scale (FSS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Impact of fatigue
  • Canadian Occupational Performance Measure COPM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Quality of life-overall [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    One question on rating overall quality of life (VAS scale). Used for patient and caregiver.
Not Provided
Not Provided
 
Effectiveness Study of Occupational Therapy in Parkinson's Disease
Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.
  • 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
    Intervention: Behavioral: Occupational Therapy
  • 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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
191
June 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01336127
W.OR09-29
No
Radboud University
Radboud University
Prinses Beatrix Spierfonds
Principal Investigator: Marten Munneke, Phd Radboud University
Radboud University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP