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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement of ability to recall extent of condition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's as defined by the UK PDS Brain Bank Criteria
排除标准
- •Unable to complete questionnaires in English.
结局指标
主要结局
Improvement of ability to recall extent of condition
时间窗: 9 months
Person with Parkinson's specific quality of life using the Parkinson's Disease Questionnaire for both participant and carer.
次要结局
- Abnormal Involuntary Movement Scale(9 months)
- Grooved peg board test(9 months)
- Unified Parkinson's Disease Rating Scale(9 months)
- Mini Mental State Exam(9 months)
- 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(9 months)
- Patient Competency Rating Scale(9 months)
- Patient Generated Index(9 months)
- The tapping test(9 months)
- Parkinson's' Disease Questionnaire(9 months)