Help Optimise and Mobilise Elders (H.O.M.E) (HOME)
2022年8月1日 更新者：JurongHealth
During hospitalisations, older inpatients commonly face issues such as immobility, loss of independence, and functional decline.
This leads them down the cascade of dependency with consequent increased risk of adverse outcomes, institutionalisation as well as higher post-acute care costs.
The investigators hypothesize that by implementing a mobility intervention in the inpatient setting, patients would be able to maintain their function upon discharge and avoid the cascade of dependency.
As such, the investigators aim to do this by implementing and evaluating a mobility intervention, while optimising reversible factors affecting mobility among inpatients admitted to a geriatric unit in Singapore.
The investigators will also examine the cost impact of a mobility focused model of care and also adopt the effectiveness-implementation hybrid Type 2 design where both effectiveness and implementation spheres are tested simultaneously.
調査の概要
詳細な説明
Aim 1: To examine the effectiveness of multicomponent, mobility-focused model of care in reducing iatrogenic complications and improving patient outcomes. Adopting the Institute for Healthcare Improvement's (IHI) 4Ms framework ("Mobility", "Mentation, "Medication", and "What Matters"), the investigators will examine the effectiveness of timely and individually catered mobility interventions which not only increase mobilization but also optimize factors inhibiting mobility for elderly inpatients. It is hypothesized that the mobility outcomes, such as maximum distance walked and mobilization frequency will be significantly improved for patients who receive the intervention compared to those who receive standard care.
Aim 2: To examine the cost impact of a mobility-focused model of care. The investigators will examine whether the cost of these multicomponent, mobility-focused interventions can be offset from cost savings from early mobilisation benefits, by comparing healthcare utilization costs between-groups. Further to that, a cost effectiveness analysis will be performed should functional effectiveness be observed. For the primary cost impact objective, it is hypothesized that the cost savings arising from reduction in bed days of hospitalization and other medical costs incurred during study period will outweigh the cost of implementing this model of care. In addition, it is also hypothesized that the proposed intervention will be cost-effective through achieving better functional outcomes for patients, with lower costs required.
Aim 3: To evaluate the implementation outcomes of multicomponent, mobility-focused model of care in the process of this intervention. It is hypothesized that this intervention will have good acceptability, feasibility, penetration, implementation costs and sustainability.
研究の種類
介入
入学 (予想される)
90
段階
- 適用できない
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。
研究連絡先
- 名前：Melanie Tan Dr
- 電話番号：67165237
- メール：melanie_tan@nuhs.edu.sg
研究場所
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Singapore、シンガポール、609606
- Ng Teng Fong Hospital
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コンタクト：
- Melanie Tan Dr
- 電話番号：67165237
- メール：melanie_tan@nuhs.edu.sg
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副調査官：
- Seok Mei Lim Dr
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副調査官：
- Dina Ee Dr
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副調査官：
- Weng Kin Lai
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副調査官：
- Russell Yoong
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副調査官：
- Lydia Au Dr
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副調査官：
- Bing Kit Chan
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Singapore、シンガポール、768024
- Geriatrics Education and Research Institute
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コンタクト：
- Lau Lay Khoon Dr
- 電話番号：68078031
- メール：lau.charlene.lk@geri.com.sg
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副調査官：
- Tou Nien Xiang Dr
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副調査官：
- Ding Yew Yoong Prof
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副調査官：
- Michelle Jessica Pereira Dr
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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
21年～110年 (大人、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:
- Newly admitted patients to the geriatric service
- Aged 75 years and above
- Mobile with or without the use of a walking aid
Exclusion Criteria:
- Vancomycin-resistant enterococcus (VRE) status
- Requires droplet or airborne precautions
- Critically ill
- Haemodynamically instability
- Requires more than 4-hourly parameters
- Systolic blood pressure <90 mmHg
- Heart rate >100beats/min
- Non-ambulant patients
- With advanced dementia (Functional Assessment Staging Scale [FAST] 7 dementia)
- Fulfills direct admission to another subspecialty unit
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：防止
- 割り当て：非ランダム化
- 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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実験的：Intervention
Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.
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The intervention group will receive early therapist review (within one working day of admission to HOME unit), to be mobilised at least three times a day.
They will also receive additional group exercise therapy sessions, as well as nurse screening for geriatric syndromes.
Besides that, they will be screened for 4Ms (Mobility, Mentation, Medication, What Matters) by doctor on admission.
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介入なし：Control
The control group will receive usual care as per current ward practice.
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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 |
|---|---|---|
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Change in maximum distance walked
時間枠：Upon admission and at the point of discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The total distance covered by the research participant (in meter)
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Upon admission and at the point of discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Mobilisation frequency
時間枠：Through the duration of admission
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Number of times mobilised.
The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.
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Through the duration of admission
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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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Change in modified barthel score
時間枠：Upon admission, at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay), and one-month post discharge
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The score ranges from 0 to 100 with 0 as the worst outcome
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Upon admission, at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay), and one-month post discharge
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Change in gait speed
時間枠：Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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4 meter gait speed test (meter/second)
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Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Inpatient length of stay and discharge location
時間枠：The duration of admission and upon discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The duration of admission (days) and the location the respective participant is discharged to
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The duration of admission and upon discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
時間枠：At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Each of the complication will be measured in nominal scale; 0 denotes the absence of the complication while 1 denotes the presence of the complications.
The total number of complications arise will be calculated.
The greater the number indicates poorer outcome
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At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Gross amount of patient's bill during index admission, considering subsidy level
時間枠：At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The total gross amount of participant's bill during index admission.
The subsidy level will be documented
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At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The intervention related costs for group therapy
時間枠：At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The number of group therapy sessions attended by the participant multiply by the cost for one group therapy session.
The subsidy level will be documented.
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At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mortality
時間枠：1-month follow-up post-discharge
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1 denotes survival while 0 denotes the participant passed away
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1-month follow-up post-discharge
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Readmission
時間枠：1-month follow-up post-discharge
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The number of readmission due to the index admission within 30 days post discharged
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1-month follow-up post-discharge
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Healthcare utilisation data and associated costs
時間枠：1-month follow-up post-discharge
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Number of visits (associated with index admission) to emergency department, specialist outpatient clinic, general practitioner and the associated costs within 30 days post-discharged
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1-month follow-up post-discharge
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Ambulatory status
時間枠：1-month follow-up post-discharge
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Self-reported by the participant.
Four options: 0 denotes bed-bound, 1 denotes chair-bound, 2 denotes assisted (furniture cruiser, walking frame, rollator frame, quadstick, single point stick); 4 denotes independent
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1-month follow-up post-discharge
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Fall
時間枠：1-month follow-up post-discharge
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0 denotes no fall; 1 denotes fall(s) occured (within 30days post-discharged)
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1-month follow-up post-discharge
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Utilisation of community resources
時間枠：1-month follow-up post-discharge
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Self-reported by the participant: Five options: 0 denotes home care; 1 denotes day care; 2 denotes meals on wheels; 3 denotes medical escort service; 4 denotes home personal care
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1-month follow-up post-discharge
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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。
スポンサー
捜査官
- 主任研究者：Melanie Tan Dr、Ng Teng Fong General Hospital
- 主任研究者：Lau Lay Khoon Dr、Geriatric Education and Research Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.
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- Hastings SN, Sloane R, Morey MC, Pavon JM, Hoenig H. Assisted early mobility for hospitalized older veterans: preliminary data from the STRIDE program. J Am Geriatr Soc. 2014 Nov;62(11):2180-4. doi: 10.1111/jgs.13095. Epub 2014 Oct 30.
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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 (予想される)
2022年7月25日
一次修了 (予想される)
2023年1月31日
研究の完了 (予想される)
2023年9月30日
試験登録日
最初に提出
2022年6月25日
QC基準を満たした最初の提出物
2022年8月1日
最初の投稿 (実際)
2022年8月2日
学習記録の更新
投稿された最後の更新 (実際)
2022年8月2日
QC基準を満たした最後の更新が送信されました
2022年8月1日
最終確認日
2022年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GERI1627
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services & Outcomes Research).
IPD 共有時間枠
During study period.
IPD 共有アクセス基準
Via secure platforms (files to be encrypted with password).
For the purposes of data sharing and data analysis.
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書（CSR）
- 分析コード
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。