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

Primary Purpose

Mobility Limitation, Functional Disturbance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Multicomponent, mobility-focused intervention
Sponsored by
JurongHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation focused on measuring Elderly, Geriatric, Mobility, Inpatient, Functional Decline, Mobility Intervention, Gait speed, Maximum distance walked, Cost impact, length of stay, Multidisciplinary, Implementation study, 4Ms (Mobility, Mentation, Medication, What Matters), Nursing screen, Group therapy

Eligibility Criteria

21 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ng Teng Fong Hospital
  • Geriatrics Education and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.

The control group will receive usual care as per current ward practice.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2022
Last Updated
August 1, 2022
Sponsor
JurongHealth
Collaborators
Geriatric Education and Research Institute, National Healthcare Group, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05484063
Brief Title
Help Optimise and Mobilise Elders (H.O.M.E)
Acronym
HOME
Official Title
Help Optimise and Mobilise Elders (H.O.M.E)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 25, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JurongHealth
Collaborators
Geriatric Education and Research Institute, National Healthcare Group, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Functional Disturbance
Keywords
Elderly, Geriatric, Mobility, Inpatient, Functional Decline, Mobility Intervention, Gait speed, Maximum distance walked, Cost impact, length of stay, Multidisciplinary, Implementation study, 4Ms (Mobility, Mentation, Medication, What Matters), Nursing screen, Group therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a quasi-experimental design study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive usual care as per current ward practice.
Intervention Type
Other
Intervention Name(s)
Multicomponent, mobility-focused intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in maximum distance walked
Description
The total distance covered by the research participant (in meter)
Time Frame
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)
Title
Mobilisation frequency
Description
Number of times mobilised. The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.
Time Frame
Through the duration of admission
Secondary Outcome Measure Information:
Title
Change in modified barthel score
Description
The score ranges from 0 to 100 with 0 as the worst outcome
Time Frame
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
Title
Change in gait speed
Description
4 meter gait speed test (meter/second)
Time Frame
Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Title
Inpatient length of stay and discharge location
Description
The duration of admission (days) and the location the respective participant is discharged to
Time Frame
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)
Title
Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
Description
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
Time Frame
At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Title
Gross amount of patient's bill during index admission, considering subsidy level
Description
The total gross amount of participant's bill during index admission. The subsidy level will be documented
Time Frame
At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Title
The intervention related costs for group therapy
Description
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.
Time Frame
At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Other Pre-specified Outcome Measures:
Title
Mortality
Description
1 denotes survival while 0 denotes the participant passed away
Time Frame
1-month follow-up post-discharge
Title
Readmission
Description
The number of readmission due to the index admission within 30 days post discharged
Time Frame
1-month follow-up post-discharge
Title
Healthcare utilisation data and associated costs
Description
Number of visits (associated with index admission) to emergency department, specialist outpatient clinic, general practitioner and the associated costs within 30 days post-discharged
Time Frame
1-month follow-up post-discharge
Title
Ambulatory status
Description
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
Time Frame
1-month follow-up post-discharge
Title
Fall
Description
0 denotes no fall; 1 denotes fall(s) occured (within 30days post-discharged)
Time Frame
1-month follow-up post-discharge
Title
Utilisation of community resources
Description
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
Time Frame
1-month follow-up post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Tan Dr
Phone
67165237
Email
melanie_tan@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Tan Dr
Organizational Affiliation
Ng Teng Fong General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lau Lay Khoon Dr
Organizational Affiliation
Geriatric Education and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ng Teng Fong Hospital
City
Singapore
ZIP/Postal Code
609606
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Tan Dr
Phone
67165237
Email
melanie_tan@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Seok Mei Lim Dr
First Name & Middle Initial & Last Name & Degree
Dina Ee Dr
First Name & Middle Initial & Last Name & Degree
Weng Kin Lai
First Name & Middle Initial & Last Name & Degree
Russell Yoong
First Name & Middle Initial & Last Name & Degree
Lydia Au Dr
First Name & Middle Initial & Last Name & Degree
Bing Kit Chan
Facility Name
Geriatrics Education and Research Institute
City
Singapore
ZIP/Postal Code
768024
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lau Lay Khoon Dr
Phone
68078031
Email
lau.charlene.lk@geri.com.sg
First Name & Middle Initial & Last Name & Degree
Tou Nien Xiang Dr
First Name & Middle Initial & Last Name & Degree
Ding Yew Yoong Prof
First Name & Middle Initial & Last Name & Degree
Michelle Jessica Pereira Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services & Outcomes Research).
IPD Sharing Time Frame
During study period.
IPD Sharing Access Criteria
Via secure platforms (files to be encrypted with password). For the purposes of data sharing and data analysis.
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