Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment (PrAISED2)
調査の概要
詳細な説明
Background and study aims People with memory problems can struggle with everyday activities and may stop doing things they want to do. They are more prone to accidents and have a higher risk of falling. Occupational therapists can advise how to do daily activities more easily and safely. Physiotherapists can teach exercises which increase activity and improve balance, and may help maintain memory. There is little research on how to make these interventions work for with people with memory problems. The aim of this study is to compare an activity and exercise programme developed for people with memory problems to standard falls prevention assessment and advice.
Who can participate? Patients aged 65 or over with early dementia or memory problems, recruited from memory clinics or the 'Join Dementia Research' register
What does the study involve? Participants are randomly allocated to either the control group or the intervention group. The control group receive standard brief falls assessment and advice, and up to two further visits if required. The intervention group receive an assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. The intervention is delivered over 1 year in participants' own homes, and is tailored to individual interests, abilities and need for supervision. Participants are encouraged to exercise by themselves or with family members between visits, and once the programme ends. Researchers visit at the start of the study and after 12 months to measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants complete monthly falls diaries over 15 months. The researchers conduct interviews and video record some therapy sessions to help understand how the programme works in practice.
What are the possible benefits and risks of participating? Some participants may benefit from taking part in the intervention, as exercise is generally known to be beneficial to health and well-being, including benefits to heart, blood pressure, diabetes, joints, mood and daily life. These participants may find that they are better able to do their daily activities. All participants and their relatives may enjoy having the researchers coming to visit them in their house. Some people appreciate having the opportunity to contribute to the well-being of others through research.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Derbyshire
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Derby、Derbyshire、イギリス、DE22 3LZ
- 募集
- Derbyshire Healthcare NHS Foundation Trust
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コンタクト：
- Simon Thacker
- 電話番号：01332623683
- メール：Simon.thacker@derbyshcft.nhs.uk
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コンタクト：
- Gemma Harrison
- 電話番号：33474 01332623700
- メール：gemma.harrison3@nhs.net
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Lincolnshire
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Lincoln、Lincolnshire、イギリス、NG34 8GG
- 募集
- Lincolnshire Partnership NHS Foundation Trust
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コンタクト：
- Carol Duff
- 電話番号：01522500690
- メール：Carol.Duff@LPFT.nhs.uk
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コンタクト：
- Tracy McCranor
- 電話番号：07795426736
- メール：Tracy.McCranor@lpft.nhs.uk
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Notts
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Nottingham、Notts、イギリス、NG3 6AA
- 募集
- Nottinghamshire Healthcare NHS Foundation Trust
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コンタクト：
- Helen Smith
- 電話番号：01158837826
- メール：Helen.smith@nottshc.nhs.uk
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コンタクト：
- Kehinde Junaid
- 電話番号：01159560884
- メール：Kehinde.Junaid@nottshc.nhs.uk
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Somerset
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Bath、Somerset、イギリス、BA1 3NG
- 募集
- RICE - Research Institute for the Care of Older People
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コンタクト：
- Vanessa Bishop
- 電話番号：01225 476420
- メール：V.Bishop@bath.ac.uk
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コンタクト：
- Lola Dali-Kemmery
- 電話番号：01225 476420
- メール：L.Dali-Kemmery@bath.ac.uk
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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
説明
Inclusion Criteria:
- Age 65 or over (no maximum)
- Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia)
- Have a carer or friend who knows the participant well (at least one hour a week contact over the phone, internet, or in person), and is willing and able to act as an informant
- Able to walk without human help
- Able to communicate in English
- Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
- Have capacity to give consent to participate, and consenting to do so
Exclusion Criteria:
- Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's, Dementia with Lewy Bodies, or other severe neurological disease)
- Unavailable over the next year (e.g. plans to relocate or go on a long holiday, or has a life expectancy of less than a year)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control
The control group will receive standard brief falls assessment and advice.
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アクティブコンパレータ：Intervention
Therapy intervention.
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Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards.
Tailored adherence support and supervision.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disability Assessment in Dementia (DAD)
時間枠：12 months
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Primary outcomes will be disability in Activities of Daily Living (Disability Assessment in Dementia, DAD) measured 12 months after randomisation. This is as recommended in a recent NIHR systematic review [Webster 2017]. scale range is 0% to 100%. Where 0% = minimal functional ability and 100% maximal functional ability. Higher scores represent less disability in ADL and lower scores indicate more dysfunction. There are no subscales. "The total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated as N/A are not considered for the total score. For example: A score of 33 on 40 (maximum score) converted out of 100 = 83% A score of 33 on 38 (max. score with 2 N/A) converted out of 100 = 87% This will result in a final score, a percentage which provides an appreciation of global function in ADL. Higher scores represent less disability in ADL while lower scores indicate more dysfunction." |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Nottingham Extended ADL Scale
時間枠：12 months
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Self-reported Activities of Daily Living (ADL) using the Nottingham Extended ADL Scale [Nouri and Lincoln 1980].
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12 months
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Falls Rate
時間枠：12 months
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Falls rate in months four-15 from randomisation (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused', and ascertained by monthly diary)
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12 months
|
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Quality of Life
時間枠：12 months
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Quality of life (EQ5D3L and EQ5D5L proxy [EuroQol Group 1990]; DemQol and DemQol proxy, including Demqol-u weights [Smith 2005; Mulhern 2013])
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12 months
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Mood or 'Affect'
時間枠：12 months
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Mood or 'Affect' - Hospital Anxiety and Depression Scale (HADS [Zigmond and Snaith 1983]; Apathy Evaluation Scale - AES [Marin, Biedrzycki and Firinciogullari 1991])
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12 months
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Physical activity
時間枠：12 months
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Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire [Stel 2004], pedometers
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12 months
|
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Cognition
時間枠：12 months
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three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment - MoCA [Nasreddine 2005], verbal fluency (from MoCA)
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12 months
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Time to first fall
時間枠：12 months
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Time to first fall (from diary)
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12 months
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Rate of fractures and injurious falls
時間枠：12 months
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Rate of fractures and injurious falls (from diary)
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12 months
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Rate of hospital and care home admissions, and days spent in hospital
時間枠：12 months
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Rate of hospital and care home admissions, and days spent in hospital (from diary, hospital administrative records)
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12 months
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Carer strain
時間枠：12 months
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Carer strain (Carergiver Strain Index [Robinson 1983]).
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12 months
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Carer health-related quality of life
時間枠：12 months
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Carer health-related quality of life (EQ5D-5L [EuroQol Group 1990])
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12 months
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Personality
時間枠：12 months
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Personality (Big Five Personality Inventory- short [BFI-10, Rammstedt and John 2007])
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12 months
|
協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)完了
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University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない