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Help Optimise and Mobilise Elders (H.O.M.E) (HOME)

1. August 2022 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Singapur
      • Singapore, Singapur, 609606
        • Ng Teng Fong Hospital
        • Kontakt:
        • Unterermittler:
          • Seok Mei Lim Dr
        • Unterermittler:
          • Dina Ee Dr
        • Unterermittler:
          • Weng Kin Lai
        • Unterermittler:
          • Russell Yoong
        • Unterermittler:
          • Lydia Au Dr
        • Unterermittler:
          • Bing Kit Chan
      • Singapore, Singapur, 768024
        • Geriatrics Education and Research Institute
        • Kontakt:
        • Unterermittler:
          • Tou Nien Xiang Dr
        • Unterermittler:
          • Ding Yew Yoong Prof
        • Unterermittler:
          • Michelle Jessica Pereira Dr

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre bis 110 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention
Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.
Sonstiges: Multicomponent, mobility-focused intervention
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.
Kein Eingriff: Control
The control group will receive usual care as per current ward practice.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in maximum distance walked
Zeitfenster: 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)
The total distance covered by the research participant (in meter)
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)
Mobilisation frequency
Zeitfenster: Through the duration of admission
Number of times mobilised. The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.
Through the duration of admission

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in modified barthel score
Zeitfenster: 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
The score ranges from 0 to 100 with 0 as the worst outcome
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
Change in gait speed
Zeitfenster: Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
4 meter gait speed test (meter/second)
Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Inpatient length of stay and discharge location
Zeitfenster: 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)
The duration of admission (days) and the location the respective participant is discharged to
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)
Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
Zeitfenster: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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
At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Gross amount of patient's bill during index admission, considering subsidy level
Zeitfenster: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
The total gross amount of participant's bill during index admission. The subsidy level will be documented
At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
The intervention related costs for group therapy
Zeitfenster: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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.
At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mortality
Zeitfenster: 1-month follow-up post-discharge
1 denotes survival while 0 denotes the participant passed away
1-month follow-up post-discharge
Readmission
Zeitfenster: 1-month follow-up post-discharge
The number of readmission due to the index admission within 30 days post discharged
1-month follow-up post-discharge
Healthcare utilisation data and associated costs
Zeitfenster: 1-month follow-up post-discharge
Number of visits (associated with index admission) to emergency department, specialist outpatient clinic, general practitioner and the associated costs within 30 days post-discharged
1-month follow-up post-discharge
Ambulatory status
Zeitfenster: 1-month follow-up post-discharge
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
1-month follow-up post-discharge
Fall
Zeitfenster: 1-month follow-up post-discharge
0 denotes no fall; 1 denotes fall(s) occured (within 30days post-discharged)
1-month follow-up post-discharge
Utilisation of community resources
Zeitfenster: 1-month follow-up post-discharge
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
1-month follow-up post-discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

JurongHealth

Mitarbeiter

National Healthcare Group, Singapore
Geriatric Education and Research Institute

Ermittler

  • Hauptermittler: Melanie Tan Dr, Ng Teng Fong General Hospital
  • Hauptermittler: Lau Lay Khoon Dr, Geriatric Education and Research Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

25. Juli 2022

Primärer Abschluss (Voraussichtlich)

31. Januar 2023

Studienabschluss (Voraussichtlich)

30. September 2023

Studienanmeldedaten

Zuerst eingereicht

25. Juni 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. August 2022

Zuerst gepostet (Tatsächlich)

2. August 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. August 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. August 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GERI1627

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services & Outcomes Research).

IPD-Sharing-Zeitrahmen

During study period.

IPD-Sharing-Zugriffskriterien

Via secure platforms (files to be encrypted with password). For the purposes of data sharing and data analysis.

Art der unterstützenden IPD-Freigabeinformationen

  • Studienprotokoll
  • Statistischer Analyseplan (SAP)
  • Einwilligungserklärung (ICF)
  • Klinischer Studienbericht (CSR)
  • Analytischer Code

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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