Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial (ATUTI)
2014年2月14日 更新者：Louise Demers、Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Experimental Control Investigation of the Impact of an Assistive Technology Updating and Tune up Intervention on the User-caregiver Dyad: a Multi-site Trial
The purpose of this study is to determine the effectiveness of an assistive technology updating and tune up intervention on users and their caregivers. This intervention includes 4 components:
- an in-residence assessment of the mobility preferences of the older person and his/her caregiver
- a detailed review of forms of assistance, technological and human, that are currently being used
- recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy
- therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver. The intervention is provided to the immediate treatment following the administration of baseline measures and the delayed intervention group six weeks later, after an additional baseline measurement. The treatment is six weeks long and the follow-up is 26 weeks.
Hypothesis 1: For community-dwelling older people, an intervention that increases the appropriateness of existing or new assistive technology(AT) for mobility or self-care will alter established patterns of human assistance, such that caregiver burden is reduced or eliminated.
Hypothesis 2: At the same time, AT users will report less difficulty in mobility or self-care, as well as enhanced subjective well-being, and satisfaction with their modified personal assistance strategy.
Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or psychological demands and increased satisfaction with their caregiving-related activities compared with
- the pre-intervention period
- caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical and/or psychological demands on helpers will be associated with increases in device users' satisfaction with their personal assistance strategies.
調査の概要
研究の種類
介入
入学 (実際)
88
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
British Columbia
-
Vancovuer、British Columbia、カナダ、V6B 5K3
- Simon Fraser University
-
-
Quebec
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Montreal、Quebec、カナダ
- Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
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Montreal、Quebec、カナダ
- the Centre de santé et des services sociaux Cavendish
-
Montreal、Quebec、カナダ
- the Centre de santé et des services sociaux de Laval
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Users: Aged 65 years and over
- Have moderate to severe disability that limits their ability to move from place to place independently and/or to perform self-care activities.
- Living at home
- Receiving 2 or more hour per week of assistance with mobility and/or self-care activities from a non-professional, caregiver who is also willing to take part in the study.
- Those caregivers will be adults aged 18 years and over.
Exclusion Criteria:
- Assistive technology users will be excluded if they have severe aphasia, are currently on a community occupational therapist caseload, or are unable to communicate in English or French.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
実験的：Immediate intervention
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
|
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
|
|
実験的：Delayed Intervention
Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).
|
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
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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 |
時間枠 |
|---|---|
|
Assessment of Life Habits
時間枠：baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
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baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
|
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Caregivers: Caregiver Assistive Technology Outcome Measure
時間枠：base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
|
base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Individually Prioritized Problem Assessment
時間枠：Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
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Functional Autonomy Measurement System
時間枠：Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Psychological Impact of Assistive Devices Scale
時間枠：Imediately after intervention. 16 weeks later
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Imediately after intervention. 16 weeks later
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Satisfaction with Personal Assistance Strategy
時間枠：Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Louise Demers, PhD、Université de Montréal
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年6月1日
一次修了 (実際)
2011年8月1日
研究の完了 (実際)
2011年8月1日
試験登録日
最初に提出
2009年6月24日
QC基準を満たした最初の提出物
2009年6月24日
最初の投稿 (見積もり)
2009年6月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月19日
QC基準を満たした最後の更新が送信されました
2014年2月14日
最終確認日
2014年2月1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。