Effectiveness Study of Occupational Therapy in Parkinson's Disease (OTiP)
This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Prinses Beatrix Spierfonds
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01336127
First received: March 17, 2011
Last updated: February 11, 2013
Last verified: April 2011
| March 17, 2011 |
| February 11, 2013 |
| 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).
|
| 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. |
| |
| Active, not recruiting |
| 192 |
| 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 Medical Centre |
|
|
| Radboud University |
| April 2011 |