- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT05484063
Help Optimise and Mobilise Elders (H.O.M.E) (HOME)
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Melanie Tan Dr
- Telefonszám: 67165237
- E-mail: melanie_tan@nuhs.edu.sg
Tanulmányi helyek
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Singapore, Szingapúr, 609606
- Ng Teng Fong Hospital
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Kapcsolatba lépni:
- Melanie Tan Dr
- Telefonszám: 67165237
- E-mail: melanie_tan@nuhs.edu.sg
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Alkutató:
- Seok Mei Lim Dr
-
Alkutató:
- Dina Ee Dr
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Alkutató:
- Weng Kin Lai
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Alkutató:
- Russell Yoong
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Alkutató:
- Lydia Au Dr
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Alkutató:
- Bing Kit Chan
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Singapore, Szingapúr, 768024
- Geriatrics Education and Research Institute
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Kapcsolatba lépni:
- Lau Lay Khoon Dr
- Telefonszám: 68078031
- E-mail: lau.charlene.lk@geri.com.sg
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Alkutató:
- Tou Nien Xiang Dr
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Alkutató:
- Ding Yew Yoong Prof
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Alkutató:
- Michelle Jessica Pereira Dr
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: 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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Nincs beavatkozás: Control
The control group will receive usual care as per current ward practice.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Change in maximum distance walked
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Change in modified barthel score
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Mortality
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Melanie Tan Dr, Ng Teng Fong General Hospital
- Kutatásvezető: Lau Lay Khoon Dr, Geriatric Education and Research Institute
Publikációk és hasznos linkek
Általános kiadványok
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- Olson EV, Johnson BJ, Thompson LF. The hazards of immobility. 1967. Am J Nurs. 1990 Mar;90(3):43-8. No abstract available.
- Hirsch CH, Sommers L, Olsen A, Mullen L, Winograd CH. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990 Dec;38(12):1296-303. doi: 10.1111/j.1532-5415.1990.tb03451.x.
- Mate KS, Berman A, Laderman M, Kabcenell A, Fulmer T. Creating Age-Friendly Health Systems - A vision for better care of older adults. Healthc (Amst). 2018 Mar;6(1):4-6. doi: 10.1016/j.hjdsi.2017.05.005. Epub 2017 Aug 1.
- Surkan MJ, Gibson W. Interventions to Mobilize Elderly Patients and Reduce Length of Hospital Stay. Can J Cardiol. 2018 Jul;34(7):881-888. doi: 10.1016/j.cjca.2018.04.033. Epub 2018 May 9.
- Smith TO, Sreekanta A, Walkeden S, Penhale B, Hanson S. Interventions for reducing hospital-associated deconditioning: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Sep-Oct;90:104176. doi: 10.1016/j.archger.2020.104176. Epub 2020 Jul 6.
- Murray ME, Wells TJ, Callen BL. Hospital resource utilization and functional decline of geriatric patients. Nurs Econ. 2003 May-Jun;21(3):114-9. No abstract available.
- Loyd C, Markland AD, Zhang Y, Fowler M, Harper S, Wright NC, Carter CS, Buford TW, Smith CH, Kennedy R, Brown CJ. Prevalence of Hospital-Associated Disability in Older Adults: A Meta-analysis. J Am Med Dir Assoc. 2020 Apr;21(4):455-461.e5. doi: 10.1016/j.jamda.2019.09.015. Epub 2019 Nov 14.
- Wu HY, Sahadevan S, Ding YY. Factors associated with functional decline of hospitalised older persons following discharge from an acute geriatric unit. Ann Acad Med Singap. 2006 Jan;35(1):17-23.
- Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x.
- 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.
- Liu B, Moore JE, Almaawiy U, Chan WH, Khan S, Ewusie J, Hamid JS, Straus SE; MOVE ON Collaboration. Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation. Age Ageing. 2018 Jan 1;47(1):112-119. doi: 10.1093/ageing/afx128.
- 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.
- Hastings SN, Choate AL, Mahanna EP, Floegel TA, Allen KD, Van Houtven CH, Wang V. Early Mobility in the Hospital: Lessons Learned from the STRIDE Program. Geriatrics (Basel). 2018 Dec;3(4):61. doi: 10.3390/geriatrics3040061. Epub 2018 Sep 26.
- Smart DA, Dermody G, Coronado ME, Wilson M. Mobility Programs for the Hospitalized Older Adult: A Scoping Review. Gerontol Geriatr Med. 2018 Nov 1;4:2333721418808146. doi: 10.1177/2333721418808146. eCollection 2018 Jan-Dec.
- Hoyer EH, Friedman M, Lavezza A, Wagner-Kosmakos K, Lewis-Cherry R, Skolnik JL, Byers SP, Atanelov L, Colantuoni E, Brotman DJ, Needham DM. Promoting mobility and reducing length of stay in hospitalized general medicine patients: A quality-improvement project. J Hosp Med. 2016 May;11(5):341-7. doi: 10.1002/jhm.2546. Epub 2016 Feb 5.
- Lim SH, Ang SY, Ong HK, Lee TZY, Lee TXL, Luo EZ, Thilarajah S. Promotion of mobility among hospitalised older adults: An exploratory study on perceptions of patients, carers and nurses. Geriatr Nurs. 2020 Sep-Oct;41(5):608-614. doi: 10.1016/j.gerinurse.2020.03.015. Epub 2020 Apr 5.
- Chan EY, Samsudin SA, Lim YJ. Older patients' perception of engagement in functional self-care during hospitalization: A qualitative study. Geriatr Nurs. 2020 May - Jun;41(3):297-304. doi: 10.1016/j.gerinurse.2019.11.009. Epub 2019 Nov 29.
- Raymond MJ, Jeffs KJ, Winter A, Soh SE, Hunter P, Holland AE. The effects of a high-intensity functional exercise group on clinical outcomes in hospitalised older adults: an assessor-blinded, randomised-controlled trial. Age Ageing. 2017 Mar 1;46(2):208-213. doi: 10.1093/ageing/afw215.
- Wallin M, Talvitie U, Cattan M, Karppi SL. Construction of group exercise sessions in geriatric inpatient rehabilitation. Health Commun. 2008;23(3):245-52. doi: 10.1080/10410230802055349.
- Renner CIe, Outermans J, Ludwig R, Brendel C, Kwakkel G, Hummelsheim H. Group therapy task training versus individual task training during inpatient stroke rehabilitation: a randomised controlled trial. Clin Rehabil. 2016 Jul;30(7):637-48. doi: 10.1177/0269215515600206. Epub 2015 Aug 27.
- Kongkasuwan R, Voraakhom K, Pisolayabutra P, Maneechai P, Boonin J, Kuptniratsaikul V. Creative art therapy to enhance rehabilitation for stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1016-1023. doi: 10.1177/0269215515607072. Epub 2015 Sep 22.
- Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
- Lavis JN, Lomas J, Hamid M, Sewankambo NK. Assessing country-level efforts to link research to action. Bull World Health Organ. 2006 Aug;84(8):620-8. doi: 10.2471/blt.06.030312. Erratum In: Bull World Health Organ. 2006 Oct;84(10):840.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Várható)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- GERI1627
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- Tanulmányi Protokoll
- Statisztikai elemzési terv (SAP)
- Tájékozott hozzájárulási űrlap (ICF)
- Klinikai vizsgálati jelentés (CSR)
- Analitikai kód
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