Clinical Trial: Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study to Examine the Effects of Anosognosia on Self-Reported Quality of Life for People With Parkinson's

Brief Summary:

Anosognosia is a recognised condition for people with Parkinson's, and is the result of physiological damage on brain structure.

Surgical Parkinson Disease Nurse Specialists have noticed that when reviewing the pre-surgery videos 12 months post-DBS, patients have forgotten and are shocked at how bad their symptoms were prior to surgery (personal communication), which may not be reflected in the change in QoL reported.

This lack of awareness, while possibly helpful in everyday life, may lead to effective treatments looking ineffective, or the benefits in QoL of effective treatment appearing reduced. This confound may not only reduce the apparent effectiveness but also the related cost-effectiveness of treatment. As cost-effectiveness is determined by both size and longevity of an effect, current methods of capturing these data may be suboptimal.


Detailed Summary:

The overarching aim of this project is to identify coping mechanisms and pathological lack of self-awareness and the impact they are likely to have on patient reported quality of life (QoL) outcome measures for a chronic condition.

This will be an observational study, a case series of approx. 10 to 20 patients. These patients will be recruited over a 6 month period from the Queen Elizabeth Hospital, Birmingham and will be informed of the study during their routine pre-surgical visit.

Patients will be eligible if they are about to undergo DBS at Queen Elizabeth Hospital. If the participant has a carer, who is also willing to participate, they may also join the study. Patients will be excluded if they are unable to complete questionnaires in English.

Once recruited and following consent, a patient will complete a brief battery of questionnaires both self-reported and clinician rated prior to surgery and at their 6 month post op visit.


Sponsor: University of Birmingham

Current Primary Outcome: Improvement of ability to recall extent of condition [ Time Frame: 9 months ]

Person with Parkinson's specific quality of life using the Parkinson's Disease Questionnaire for both participant and carer.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinician's Rating Scale for Evaluating Impaired Self Awareness and Denial of Disability after Brain Injury adapted for use with PD patients.after Brain Injury, adapted for use with Parkinson's Disease patients [ Time Frame: 9 months ]
    Participants self-awareness of their Parkinson's
  • Patient Generated Index [ Time Frame: 9 months ]
    Quality of life measure
  • Abnormal Involuntary Movement Scale [ Time Frame: 9 months ]
    Occurrence of tardive dyskinesia
  • Patient Competency Rating Scale [ Time Frame: 9 months ]
    Evaluation of self-awareness following traumatic brain injury
  • Grooved peg board test [ Time Frame: 9 months ]
    Measuring motor performance
  • The tapping test [ Time Frame: 9 months ]
    Measuring motor control
  • Unified Parkinson's Disease Rating Scale [ Time Frame: 9 months ]
    Rating the extent of the participant's Parkinson's
  • Mini Mental State Exam [ Time Frame: 9 months ]
    Measure of cognitive impairment
  • Parkinson's' Disease Questionnaire [ Time Frame: 9 months ]
    PDQ-39 (Carer)


Original Secondary Outcome: Same as current

Information By: University of Birmingham

Dates:
Date Received: August 28, 2015
Date Started: August 2015
Date Completion: November 2018
Last Updated: October 24, 2016
Last Verified: September 2015