Trial Review

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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
ACTRN12609000821291
Ethics application status
Approved
Date submitted
18/09/2009
Date registered
21/09/2009
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Date results information initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Maintaining Independence: The effect of regular telephone follow-up on residential care admission and hospital readmissions in frail elderly patients recently discharged from hospital.
Scientific title
Maintaining Independence: A pilot feasibility study of regular telephone follow-up in frail elderly patients recently discharged from hospital to prevent residential care admission and hospital readmissions.
Secondary ID [1] 297738 0
nil known
Universal Trial Number (UTN)
U1111-1111-8574
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frail elderly 243874 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252045 252045 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Regular monthly telephone follow-up post-discharge, participants will be asked about their own self-rated health. If they report their health is deteriorating they will be brought for discussion at a multidisciplinary team metting and one or more relevant members of the team will then visit them at home. The intervention will continue for 3 months.
Intervention code [1] 241308 0
Prevention
Comparator / control treatment
General practitioner (GP) follow-up
Historical control cohorts recruited between January to May 2007, and November to December 2008 who recieved GP only follow-up in a study by Heppenstall et al (publication in progress)
Control group
Historical

Outcomes
Primary outcome [1] 252947 0
Institutional care admission as recorded on computerised medical records system
Timepoint [1] 252947 0
3 & 6 months post-discharge
Secondary outcome [1] 257678 0
Acute hospital admissions as recorded on computerised medical records system
Timepoint [1] 257678 0
3 & 6 months post-discharge

Eligibility
Key inclusion criteria
Aged >65 years
Discharged to own home from post-acute geriatric assessment and rehabilitation hospital
Minimum age
65 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe dementia
terminal care
non-english speaking

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients being discharged to their own home are eligible
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2009
Actual
25/11/2013
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
28/08/2014
Sample size
Target
50
Accrual to date
Final
81
Recruitment outside Australia
Country [1] 2147 0
New Zealand
State/province [1] 2147 0
Canterbury

Funding & Sponsors
Funding source category [1] 243761 0
Government body
Name [1] 243761 0
Health Research Council
Country [1] 243761 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
c/o Department of Medicine,
Princess Margaret Hospital,
PO Box 800,
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 237118 0
None
Name [1] 237118 0
Address [1] 237118 0
Country [1] 237118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243891 0
Upper South A Regional Ethics Committe
Ethics committee address [1] 243891 0
Ministry of Health,
PO Box 3877
Christchurch 8011
Ethics committee country [1] 243891 0
New Zealand
Date submitted for ethics approval [1] 243891 0
01/05/2009
Approval date [1] 243891 0
07/07/2009
Ethics approval number [1] 243891 0
URA/09/05/032

Summary
Brief summary
This study aims to improve the outcomes for frail elderly people follwoing a hospital admission. Subjects will be telephoned once per month and asked about their self-rated health. If they report their health is deteriorating following discharge they will be discussed at a multi-disciplinary team meeting and one or more relevant members of the team will visit them at home. This is a pilot feasibility/ acceptability study so participants, carers and health professionals involved will also be interviewad about their views of the study. Outcomes of residential care admission and subsequent hospital admissions will be compared with historical controls. The results will be used for a power calculation for a subsequent randomised controlled trial (RCT).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30305 0
Dr Claire Heppenstall
Address 30305 0
University of Otago, Chrsitchurch,
Department of Medicine,
Portacom A,
Burwood Hospital,
Marehau Road,
Christchurch
Country 30305 0
New Zealand
Phone 30305 0
+64 27 349 4703
Fax 30305 0
Email 30305 0
claire.heppenstall@otago.ac.nz
Contact person for public queries
Name 13552 0
Claire Heppenstall
Address 13552 0
University of Otago, Christchurch
Department of Medicine,
Portacom A, Burwood Hospital.
Christchurch
Country 13552 0
New Zealand
Phone 13552 0
+64 27 349 4703
Fax 13552 0
0064 3 337 8797
Email 13552 0
ClaireH@cdhb.govt.nz
Contact person for scientific queries
Name 4480 0
Claire Heppenstall
Address 4480 0
University of Otago, Christchurch
Department of Medicine,
Portacom A, Burwood Hospital.
Christchurch
Country 4480 0
New Zealand
Phone 4480 0
+64 27 349 4703
Fax 4480 0
0064 3 337 8797
Email 4480 0
claire.heppenstall@otago.ac.nz

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 2018 Heppenstall CP, Hanger HC, Wilkinson TJ, Dha... [More Details]
Plain language summaryNo High readmission rates. Patients welcomed interve... [More Details]

Documents added automatically
No additional documents have been identified.