Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001761257
Ethics application status
Approved
Date submitted
3/10/2018
Date registered
25/10/2018
Date last updated
1/10/2019
Date data sharing statement initially provided
1/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospitalization Process Effects on Mobility Outcomes and Recovery
Scientific title
Hospitalization Process Effects on Mobility Outcomes and Recovery
Secondary ID [1] 296245 0
none
Universal Trial Number (UTN)
None
Trial acronym
HoPE MOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute hospitalization 309899 0
acute illness 309900 0
Condition category
Condition code
Public Health 308686 308686 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
The exposure is acute hospitalization. Each participants is followed up to five days during the hospitalization period and after month via a phone call.
Intervention code [1] 312574 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307657 0
1. Subjective changes in functional status between 2 weeks prior to admission and discharge will be measured using the Modified Barthel Index (MBI).
Timepoint [1] 307657 0
End of hospitalization
Primary outcome [2] 307744 0
2, Functioning objectively using a mobility-associated functional status measure, the De Morton Mobility Index (DEMMI),
Timepoint [2] 307744 0
discharge
Secondary outcome [1] 352506 0
One month post discharge, Activities of Daily Living (IADLs), using MBI questioner.
Timepoint [1] 352506 0
one month post hospitalization
Secondary outcome [2] 352763 0
Alabama at Birmingham Life-Space Assessment (LSA), measuring community mobility.
Timepoint [2] 352763 0
one month post discharge

Eligibility
Key inclusion criteria
(1) age 70 or older, (2) self-reported pre-admission ability to walk with or without personal or assistive device, (3) cognitively intact or having available caregivers willing to participate based on intermediary reporting, and (4) the patient or the caregiver speaks Hebrew, Arabic, or Russian
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Admission diagnosis of acute Cerbro Vascular Accident (CVA) (2) need for mechanical ventilation, (3) patient admitted for end-of-life care, (4) prescribed mobility restriction for 24 hours or longer, or (5) patient in prescribed isolation.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics: Descriptive statistics of variables will be obtained to understand the characteristics of the study population, to evaluate distribution of subjects across subgroups for stratified analyses (e.g., age and functioning subgroups), and to identify potential confounders (in addition to a priori selected confounders, such as ethnicity, illness severity, premorbid mobility) to inform subsequent analyses. We will evaluate associations between these variables and the variable of primary interest, in-hospital mobility.
Accounting for the nested design: As patients are nested within units/hospitals, some of the variation may be attributable to the unit’s/hospital’s characteristics; thus a nested design will be used. We will test the level of nesting using the Intraclass Correlation coefficient (ICC) and account for the nested design (patients within units/hospitals) using the generalized estimating equation (GEE) approach. GEE accounts for the correlation between observations in generalized linear regression models by use of an empirical (sandwich/robust) variance estimator. GEEs estimate regression coefficients and standard errors with sampling distributions that are asymptotically normal, can be applied to test main effects and interactions, and can be used to evaluate categorical or continuous independent variables. We will specify an “identity” link and test an exchangeable working correlation matrix against an independence correlation matrix and an unstructured correlation matrix for the model that fits best..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
200
Final
Recruitment outside Australia
Country [1] 20894 0
Israel
State/province [1] 20894 0

Funding & Sponsors
Funding source category [1] 300843 0
Government body
Name [1] 300843 0
Israel Science Foundation ISF
Country [1] 300843 0
Israel
Primary sponsor type
University
Name
University of Haifa
Address
Abba Hushi Haifa 31905
Country
Israel
Secondary sponsor category [1] 300391 0
Hospital
Name [1] 300391 0
HaEmek,
Address [1] 300391 0

Afula (HaEMEK)
David 15 street
Country [1] 300391 0
Israel
Secondary sponsor category [2] 300469 0
Hospital
Name [2] 300469 0
Carmel,
Address [2] 300469 0
Michal 7
Haifa Israel
Country [2] 300469 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301611 0
University of Haifa IRB board
Ethics committee address [1] 301611 0
Abba Hushi 140
Haifa
Israel
Ethics committee country [1] 301611 0
Israel
Date submitted for ethics approval [1] 301611 0
04/10/2017
Approval date [1] 301611 0
31/10/2017
Ethics approval number [1] 301611 0

Summary
Brief summary
For hospitalized older adults, every day of immobility is associated with reduced muscle mass and strength, leading to a host of negative outcomes, including short- and long-term functional decline. Despite the established knowledge of the deleterious effects of immobility, older adults, even those able to ambulate independently, spend most of their hospital stay lying in bed. Emergent evidence suggests that in-hospital immobility is a complex phenomenon affected by a wide range of factors, such as personal predisposing characteristics, intrinsically related to patients’ clinical, physical, mental, and emotional condition; and hospitalization process factors, related to the care processes, the characteristics of the healthcare organization, and the assistance of informal caregiving. Nonetheless, a comprehensive model postulating the relative contribution of and interrelations between these risk factors has yet to be proposed and empirically tested. Moreover, despite increasing realization of the importance of tailoring mobility recommendations that account for patients’ predisposing clinical and functional conditions, specific mobility thresholds are yet to be established.
To achieve this goal, we will conduct a prospective multi-center study of 1,200 hospitalized older adults nested in 40 internal medical units in nine hospitals across Israel and a sample of 340 nurses, nurse aides, and physicians from these units. Data will be collected in five phases: (1) prior to patients’ recruitment, on the hospital setting and on staff knowledge and attitudes; (2) at admission, on personal risk factors including physical, medical, and cognitive function; (3) during the hospitalization period, on healthcare and caregiving-related factors (from patient-survey and electronic health record data) and on actual mobility levels (assessed up to 5 hospitalization days using accelerometers); (4) at discharge, on physical, medical, and cognitive function; (5) and 1 month post-discharge via a telephone interview, on hospitalization outcomes. Analysis will employ multiple linear regressions and structural equation modeling, accounting for the multilevel design.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87550 0
Dr Maayan Agmon
Address 87550 0
Abba Hushi 140
University of Haifa
Country 87550 0
Israel
Phone 87550 0
+972549001609
Fax 87550 0
Email 87550 0
[email protected]
Contact person for public queries
Name 87551 0
Dr Maayan Agmon
Address 87551 0
Abba Hushi 140
University of Haifa
Haifa Israel
Country 87551 0
Israel
Phone 87551 0
+972549001609
Fax 87551 0
Email 87551 0
[email protected]
Contact person for scientific queries
Name 87552 0
Dr Maayan Agmon
Address 87552 0
Abba Hushi 140
University of Haifa
Haifa Israel
Country 87552 0
Israel
Phone 87552 0
+972549001609
Fax 87552 0
Email 87552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5088Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.