European Compliance Study in Parkinson's Disease
European Study of Therapeutic Compliance in Parkinson's Disease
調査の概要
状態
条件
詳細な説明
This is an observational study of how patients with Parkinson's disease take their medication. Antiparkinson medication will be monitored using electronic pill bottles, MEMS, Aardex®, Switzerland (which contain a microprocessor in the cap that records the time and date of bottle openings). This gives information about the amount of prescribed medication taken (total compliance), the percentage of days when the correct number of doses is taken (daily compliance), and the percentage of doses taken at the correct time interval (timing compliance).
Five countries will be involved, (UK, Germany, Italy, Spain and France). The total number of patients recruited across Europe will be 144. The study size has been calculated based on a single centre study in Glasgow where 2/3 of 120 patients were scheduled to undergo electronic monitoring as part of a different study design. Accordingly data is available which has informed the expected number of patients completing the study (around a 10% drop out rate) and in order to test 6 key variables with potential influence on therapy compliance and using the general statistical guide that between 10 and 20 patients should be studied per variable to be examined, a sample size of around 120 evaluable patients has been calculated.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Glasgow、イギリス、G51 4TF
- Dr D Grosset
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
説明
Inclusion Criteria:
- Men or Women between 18 and 80 years.
- Patient has idiopathic Parkinson's Disease according to Brain Bank criteria. - Reference Hughes A J, Daniel S E, Kilford L, Lees A J, Accuracy of Clinical - Diagnosis of Idiopathic Parkinson's disease; A clinical Pathological study of 100 cases, JNNP 1992, 55(3): 181 - 184
- Patient is on stable doses of anti-Parkinson's disease medication, which are not expected to change during the study period.
- Patient is taking levodopa and/or dopamine agonist treatment.
- Patient (assisted by a carer where appropriate) is able to take their medication using the MEMS (electronic monitoring) containers.
- Patients using a dosette box or similar device for their medication are willing to use the MEMS containers for their PD medication
- The investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the MEMS device.
Exclusion Criteria:
- Patient is taking anti-Parkinson's disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). Intermittent Domperidone is allowed.
- Severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the Parkinson's disease in terms of life expectancy and levels of care required.
- Patient is expected to undergo hospital admission during the study period (such as elective surgery).
- Patient is on non standard drug treatment / combination therapy. This would include e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice.
- New antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period.
- Patient is taking only adjunct therapy (eg. Selegiline, Amantadine, anticholinergic therapy).
- Patient is taking part in a clinical trial.
研究計画
研究はどのように設計されていますか？
協力者と研究者
捜査官
- 主任研究者：Donald Grosset, MD、Southern General Hospital, Glasgow, UK
研究記録日
主要日程の研究
研究開始
一次修了
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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