ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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]

none

Universal Trial Number (UTN)

None

Trial acronym

HoPE MOR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

acute hospitalization

acute illness

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

End of hospitalization

Primary outcome [2]

2, Functioning objectively using a mobility-associated functional status measure, the De Morton Mobility Index (DEMMI),

Timepoint [2]

discharge

Secondary outcome [1]

One month post discharge, Activities of Daily Living (IADLs), using MBI questioner.

Timepoint [1]

one month post hospitalization

Secondary outcome [2]

Alabama at Birmingham Life-Space Assessment (LSA), measuring community mobility.

Timepoint [2]

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?

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]

Israel

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Israel Science Foundation ISF

Address [1]

Jabotisky 31
Jerusalem 9104001
Israel

Country [1]

Israel

Primary sponsor type

University

Name

University of Haifa

Address

Abba Hushi Haifa 31905

Country

Israel

Secondary sponsor category [1]

Hospital

Name [1]

HaEmek,

Address [1]

Afula (HaEMEK)
David 15 street

Country [1]

Israel

Secondary sponsor category [2]

Hospital

Name [2]

Carmel,

Address [2]

Michal 7
Haifa Israel

Country [2]

Israel

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Haifa IRB board

Ethics committee address [1]

Abba Hushi 140
Haifa 
Israel

Ethics committee country [1]

Israel

Date submitted for ethics approval [1]

04/10/2017

Approval date [1]

31/10/2017

Ethics approval number [1]

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

Dr Maayan Agmon

Address

Abba Hushi 140
University of Haifa

Country

Israel

Phone

+972549001609

Fax

magmon@univ.haifa.ac.il

Contact person for public queries

Name

Maayan Agmon

Address

Abba Hushi 140
University of Haifa
Haifa Israel

Country

Israel

Phone

+972549001609

Fax

magmon@univ.haifa.ac.il

Contact person for scientific queries

Name

Maayan Agmon

Address

Abba Hushi 140
University of Haifa
Haifa Israel

Country

Israel

Phone

+972549001609

Fax

magmon@univ.haifa.ac.il

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5088	Study protocol			agmon.mn@gmail.com

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically