Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

1 augusti 2022 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år till 110 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention
Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.
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.
Inget ingripande: Control
The control group will receive usual care as per current ward practice.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in maximum distance walked
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in modified barthel score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mortality
Tidsram: 1-month follow-up post-discharge
1 denotes survival while 0 denotes the participant passed away
1-month follow-up post-discharge
Readmission
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

25 juli 2022

Primärt slutförande (Förväntat)

31 januari 2023

Avslutad studie (Förväntat)

30 september 2023

Studieregistreringsdatum

Först inskickad

25 juni 2022

Först inskickad som uppfyllde QC-kriterierna

1 augusti 2022

Första postat (Faktisk)

2 augusti 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 augusti 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 augusti 2022

Senast verifierad

1 juni 2022

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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

Tidsram för IPD-delning

During study period.

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • Studieprotokoll
  • Statistisk analysplan (SAP)
  • Informerat samtycke (ICF)
  • Klinisk studierapport (CSR)
  • Analytisk kod

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera