A Biofeedback Intervention for the Prevention of Challenging Behaviour
A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury
調査の概要
詳細な説明
A multiple baseline "A-B-A" single case experimental design will be adopted with baseline, intervention, and return to baseline phases.
Participants will wear the portable monitoring device with heart rate monitor, pedometer and global positioning system (GPS) functions. A pre-calculated algorithm, developed using machine learning software will be used to predict challenging behaviour episodes 2-4 hours in advance of the event. Recent research has developed a best predictor model with a sensitivity of 82% and specificity of 42%, when averaged across two participants (in press). The device will communicate with a smart phone, via Bluetooth connectivity, when an event has been predicted.
Following enrolment in the study, participants will be randomly assigned to a treatment start time, which will follow from an initial baseline phase. During the baseline phase, participants will wear a commercially available smart watch with physiological monitoring capability, for at least one month in order to gather behaviour frequency data, and associated physiological data; no prompts will be provided. During this period, behavioural and physiological data will be sent to a secure server where a machine learning algorithm will examine the relationships between data streams and 'self-tune' to improve its prediction of challenging behaviour episodes. In the treatment phase, participants and staff will receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart watch/connected mobile phone, when an event has been predicted. This will prompt participants to implement a proactive anxiety management strategy, and will prompt staff to support the participant in completing this, if required. The strategy used will be predetermined in the participant's standard care plan e.g. breathing relaxation, reframing the problem, behavioural redirection. Details will be recorded using an adapted version of the Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in which the biofeedback prompt occurred, participant and staff responses to the biofeedback prompt, and any resulting behaviours, including the occurrence of challenging behaviour. Following the intervention phase, participants will return to a baseline phase for one month, in which no prompts will be provided. Again, details of any challenging behaviour will be recorded via the OAS-MNR.
研究の種類
段階
- 適用できない
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:
- participants who have sustained a severe injury to the brain, as determined by length of unconsciousness (greater than 24 hours), a Glasgow Coma Scale of 3 to 8 and a Post Traumatic Amnesia period greater than 1 day
- participants who are resident in the Graham Anderson House, Brain Injury Rehabilitation (BIRT) Unit
- participants presenting with challenging behaviour, during the recruitment period
- participants will NOT be excluded on the basis of comorbid psychiatric disorders or drug/alcohol use, in order to provide conclusions representative of the clinical population
- participants will NOT be excluded on the basis of being unable to provide informed consent, in order to provide conclusions representative of the clinical population
Exclusion Criteria:
- a level of cognitive impairment that would prevent individuals from understanding the feedback obtained via digital or verbal prompts
- participants without the capacity to consent, that do not provide verbal assent to participate in the study
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:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
|---|---|
|
実験的:Biofeedback intervention
Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
|
Anxiety management strategy as per standard care plan
|
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 |
|---|---|---|
|
Number of incidents of challenging behaviour
時間枠:5 months
|
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
|
5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Implementation of anxiety management strategy
時間枠:5 months
|
Number of times anxiety management strategy successfully employed
|
5 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Jonathan Evans, BSc PhD、University of Glasgow
研究記録日
主要日程の研究
研究開始 (予想される)
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。
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