Study of the Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) on Cognitive Impairment in Parkinson's Disease

NCT ID: NCT02007785

Last Updated: 2015-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-10-31

Brief Summary

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The purpose of the study will be to determine the effects of the Cognitive Orientation to daily Occupational Performance (CO-OP) as a treatment program for individuals with Parkinson's disease-related cognitive impairment. The potential effects of the CO-OP on successful engagement in meaningful activities will be examined from participants' and live-in caregivers' perspectives. Effects of the CO-OP on participant-perceived health-related quality of life and caregiver burden will also be evaluated.

Hypotheses:

1. Training with the CO-OP will have an effect or multiple effects on participation in meaningful activities and health-related quality of life for individuals with Parkinson's-related cognitive impairment.
2. Training with the CO-OP will have an effect or multiple effects on caregiver burden and health-related quality of life for caregivers of individuals with Parkinson's-related cognitive impairment.

Detailed Description

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Conditions

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Parkinson's Disease Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CO-OP treatment protocol

Participants with Parkinson's disease will be participating in up to 12 one-on-one treatment sessions with 2 sessions per week, for up to 6 weeks. Each session will last 45-60 minutes. During these treatment sessions, each participant will be taught a problem-solving strategy that teaches individuals to monitor and adjust their own actions. Participants will be guided by the principal investigator to select 5 individual treatment goals to work on during treatment. Sessions will continue until all 5 treatment goals have been met or until 12 sessions have been completed, whichever occurs earlier. Initially, each participant's respective primary caregiver will be required to attend treatment sessions, so that the caregiver may be familiar with the treatment strategy in order to coach the participant with Parkinson's disease when you he or she uses the strategy at home.

Group Type EXPERIMENTAL

CO-OP treatment protocol

Intervention Type BEHAVIORAL

Participants with Parkinson's disease will be participating in up to 12 one-on-one treatment sessions with 2 sessions per week, for up to 6 weeks. Each session will last 45-60 minutes. During these treatment sessions, each participant will be taught a problem-solving strategy that teaches individuals to monitor and adjust their own actions. Participants will be guided by the principal investigator to select 5 individual treatment goals to work on during treatment. Sessions will continue until all 5 treatment goals have been met or until 12 sessions have been completed, whichever occurs earlier. Initially, each participant's respective primary caregiver will be required to attend treatment sessions, so that the caregiver may be familiar with the treatment strategy in order to coach the participant with Parkinson's disease when you he or she uses the strategy at home.

Interventions

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CO-OP treatment protocol

Participants with Parkinson's disease will be participating in up to 12 one-on-one treatment sessions with 2 sessions per week, for up to 6 weeks. Each session will last 45-60 minutes. During these treatment sessions, each participant will be taught a problem-solving strategy that teaches individuals to monitor and adjust their own actions. Participants will be guided by the principal investigator to select 5 individual treatment goals to work on during treatment. Sessions will continue until all 5 treatment goals have been met or until 12 sessions have been completed, whichever occurs earlier. Initially, each participant's respective primary caregiver will be required to attend treatment sessions, so that the caregiver may be familiar with the treatment strategy in order to coach the participant with Parkinson's disease when you he or she uses the strategy at home.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Orientation to daily Occupational Performance

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Idiopathic Parkinson's Disease
* Presence of a live-in caregiver or significant other who is willing to participate in the study
* Montreal Cognitive Assessment (MoCA) score above 16/30 and below 26/30
* Schwab and England Activities of Daily Living Scale scores between 60% and 90%
* Hoehn and Yahr Scale scores between Stage 1 and Stage 3
* Self-reported difficulty completing routine functional activities that may be related to new cognitive changes since PD diagnosis


* Live in the same residence as participant with Parkinson's
* Be willing to participate

Exclusion Criteria

* Clinical diagnosis of atypical parkinsonism
* Clinical diagnosis of young-onset Parkinson's disease
* Co-morbidities associated with cognitive impairment
* Poorly controlled depression
* Clinical diagnosis of dementia
* Residence outside boundaries of the city of Winnipeg, Manitoba, Canada


* Scores at or below 16/30 on Montreal Cognitive Assessment (MoCA)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Catherine Bryden Dueck, O.T. Reg. (MB)

graduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine E Bryden Dueck, BMR (OT)

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Deer Lodge Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Calleo J, Burrows C, Levin H, Marsh L, Lai E, York MK. Cognitive rehabilitation for executive dysfunction in Parkinson's disease: application and current directions. Parkinsons Dis. 2012;2012:512892. doi: 10.1155/2012/512892. Epub 2011 Nov 2.

Reference Type BACKGROUND
PMID: 22135762 (View on PubMed)

Dawson DR, Gaya A, Hunt A, Levine B, Lemsky C, Polatajko HJ. Using the cognitive orientation to occupational performance (CO-OP) with adults with executive dysfunction following traumatic brain injury. Can J Occup Ther. 2009 Apr;76(2):115-27. doi: 10.1177/000841740907600209.

Reference Type BACKGROUND
PMID: 19456090 (View on PubMed)

DePoy, E., & Gitlin, L. (2005). Case Study Designs. In E. DePoy, & L. Gitlin, Introduction to Reserach: Understanding and Applying Multiple Strategies (3rd Ed.) (pp. 277-283). St. Louis, MO: Mosby.

Reference Type BACKGROUND

Disbrow EA, Russo KA, Higginson CI, Yund EW, Ventura MI, Zhang L, Malhado-Chang N, Woods DL, Sigvardt KA. Efficacy of tailored computer-based neurorehabilitation for improvement of movement initiation in Parkinson's disease. Brain Res. 2012 May 3;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9.

Reference Type BACKGROUND
PMID: 22459048 (View on PubMed)

Emre M, Aarsland D, Brown R, Burn DJ, Duyckaerts C, Mizuno Y, Broe GA, Cummings J, Dickson DW, Gauthier S, Goldman J, Goetz C, Korczyn A, Lees A, Levy R, Litvan I, McKeith I, Olanow W, Poewe W, Quinn N, Sampaio C, Tolosa E, Dubois B. Clinical diagnostic criteria for dementia associated with Parkinson's disease. Mov Disord. 2007 Sep 15;22(12):1689-707; quiz 1837. doi: 10.1002/mds.21507.

Reference Type BACKGROUND
PMID: 17542011 (View on PubMed)

Foster ER, Hershey T. Everyday Executive Function Is Associated With Activity Participation in Parkinson Disease Without Dementia. OTJR (Thorofare N J). 2011;31(1):16-22. doi: 10.3928/15394492-20101108-04.

Reference Type BACKGROUND
PMID: 21921994 (View on PubMed)

Hoops S, Nazem S, Siderowf AD, Duda JE, Xie SX, Stern MB, Weintraub D. Validity of the MoCA and MMSE in the detection of MCI and dementia in Parkinson disease. Neurology. 2009 Nov 24;73(21):1738-45. doi: 10.1212/WNL.0b013e3181c34b47.

Reference Type BACKGROUND
PMID: 19933974 (View on PubMed)

Leroi I, Collins D, Marsh L. Non-dopaminergic treatment of cognitive impairment and dementia in Parkinson's disease: a review. J Neurol Sci. 2006 Oct 25;248(1-2):104-14. doi: 10.1016/j.jns.2006.05.021. Epub 2006 Jun 27.

Reference Type BACKGROUND
PMID: 16806271 (View on PubMed)

Mohlman J, Chazin D, Georgescu B. Feasibility and acceptance of a nonpharmacological cognitive remediation intervention for patients with Parkinson disease. J Geriatr Psychiatry Neurol. 2011 Jun;24(2):91-7. doi: 10.1177/0891988711402350.

Reference Type BACKGROUND
PMID: 21546649 (View on PubMed)

Paris AP, Saleta HG, de la Cruz Crespo Maraver M, Silvestre E, Freixa MG, Torrellas CP, Pont SA, Nadal MF, Garcia SA, Bartolome MV, Fernandez VL, Bayes AR. Blind randomized controlled study of the efficacy of cognitive training in Parkinson's disease. Mov Disord. 2011 Jun;26(7):1251-8. doi: 10.1002/mds.23688. Epub 2011 Mar 25.

Reference Type BACKGROUND
PMID: 21442659 (View on PubMed)

Polatajko, H., & Mandich, A. (2004). Enabling Occupation in Children: The Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. Ottawa: CAOT Publications ACE.

Reference Type BACKGROUND

Sammer G, Reuter I, Hullmann K, Kaps M, Vaitl D. Training of executive functions in Parkinson's disease. J Neurol Sci. 2006 Oct 25;248(1-2):115-9. doi: 10.1016/j.jns.2006.05.028. Epub 2006 Jun 12.

Reference Type BACKGROUND
PMID: 16765378 (View on PubMed)

Sinforiani E, Banchieri L, Zucchella C, Pacchetti C, Sandrini G. Cognitive rehabilitation in Parkinson's disease. Arch Gerontol Geriatr Suppl. 2004;(9):387-91. doi: 10.1016/j.archger.2004.04.049.

Reference Type BACKGROUND
PMID: 15207437 (View on PubMed)

Skidmore ER, Holm MB, Whyte EM, Dew MA, Dawson D, Becker JT. The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. Neuropsychol Rehabil. 2011 Apr;21(2):208-23. doi: 10.1080/09602011.2011.552559.

Reference Type BACKGROUND
PMID: 21391121 (View on PubMed)

Vale S. Current management of the cognitive dysfunction in Parkinson's disease: how far have we come? Exp Biol Med (Maywood). 2008 Aug;233(8):941-51. doi: 10.3181/0707-MR-193. Epub 2008 Jun 5.

Reference Type BACKGROUND
PMID: 18535172 (View on PubMed)

Other Identifiers

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H2013:400

Identifier Type: -

Identifier Source: org_study_id

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