Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001274460
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
9/09/2016
Date last updated
11/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Walk to improve hospitalization outcomes for older adults
Scientific title
Evaluation of mobility intervention for prevention of acquired hospitalization functional decline among older adults
Secondary ID [1] 289779 0
N/A
Secondary ID [2] 290086 0
None
Universal Trial Number (UTN)
Trial acronym
WALK FOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospitalized older adults 299666 0
Hospital aquired functional decline 299667 0
Mobility decline 299668 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299610 299610 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will be involved in the evaluation of the changes associated with the new practice that will be implemented in the hospital. However, the new practice will be conducted by the hospital and we will no be not involved in the intervention phase. In each of the two stages we will recruit 200 participants to evaluate their level of mobility. All eligible participants will be invited to participate. The new practice will include brochures that explain the importance of in hospital mobility that will distribute by the nurses, encouragement to walk by the nursing assistants, marks on the floor of meters (to acknowledge the patients of distance walked) and record mobility in the medical records by the medical and nursing team.
Intervention code [1] 295679 0
Not applicable
Comparator / control treatment
Standard of care defined as the standard treatment in internal wards in Israel i.e., changing position, encouragement to sit on chair instead of lying in bed. Data is collected before implementation of practice change within the same hospital.
Control group
Active

Outcomes
Primary outcome [1] 299081 0
Modified Barthel Index (MBI)
Timepoint [1] 299081 0
Discharge from hospital
Secondary outcome [1] 326088 0
Phone interview that includes Modified Barthel Index (MBI)
Timepoint [1] 326088 0
one month post discharge

Eligibility
Key inclusion criteria
Cognitively intact patients age 65 and older being ambulatory with or without an assistive device in the 2 weeks before admissions
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who, on admission, had a major stroke or were in a coma, suffered from delirium (ATM4 score, 0) , were mechanically ventilated, admitted for end of life care, required staying in isolation, prescribed mobility restriction for 24 hours or longer, or were completely not mobile prior to hospitalization

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
ANCOVA to compare functional outcomes between the pre practice change and post practice change while controlling for personal risk factors.Based on G power calculation and an effect size of o.o5, 400 participants will recruit to detect significant change in function.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
30/11/2016
Actual
30/09/2016
Date of last data collection
Anticipated
31/03/2017
Actual
31/03/2017
Sample size
Target
400
Accrual to date
Final
406
Recruitment outside Australia
Country [1] 8056 0
Israel
State/province [1] 8056 0

Funding & Sponsors
Funding source category [1] 294159 0
Hospital
Name [1] 294159 0
HaEmek Medical Center
Country [1] 294159 0
Israel
Primary sponsor type
Hospital
Name
HaEmek Medical Center
Address
Yitzhak Rabin Boulevard 21, Afula 1834111 Israel
Country
Israel
Secondary sponsor category [1] 292992 0
University
Name [1] 292992 0
University of Haifa
Address [1] 292992 0
Abba Khoushy Ave 199, Haifa, 3498838, Israel
Country [1] 292992 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295567 0
University of Haifa Faculty of Health and Social Welfare
Ethics committee address [1] 295567 0
Ethics committee country [1] 295567 0
Israel
Date submitted for ethics approval [1] 295567 0
03/03/2016
Approval date [1] 295567 0
14/04/2016
Ethics approval number [1] 295567 0
1314
Ethics committee name [2] 295568 0
HaEmek Medical Center
Ethics committee address [2] 295568 0
Ethics committee country [2] 295568 0
Israel
Date submitted for ethics approval [2] 295568 0
27/07/2015
Approval date [2] 295568 0
08/08/2015
Ethics approval number [2] 295568 0
0100-15-EMC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67790 0
Dr Maayan Agmon
Address 67790 0
University of Haifa, Abba Khoushy Ave 199, Haifa, 3498838, Israel
Country 67790 0
Israel
Phone 67790 0
+972-54-9001609
Fax 67790 0
Email 67790 0
[email protected]
Contact person for public queries
Name 67791 0
Anna Zisberg
Address 67791 0
University of Haifa, Abba Khoushy Ave 199, Haifa, 3498838, Israel
Country 67791 0
Israel
Phone 67791 0
+972-58-4877772
Fax 67791 0
Email 67791 0
[email protected]
Contact person for scientific queries
Name 67792 0
Maayan Agmon
Address 67792 0
University of Haifa, Abba Khoushy Ave 199, Haifa, 3498838, Israel
Country 67792 0
Israel
Phone 67792 0
+972-54-9001609
Fax 67792 0
Email 67792 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.