Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000202369
Ethics application status
Approved
Date submitted
15/04/2008
Date registered
16/04/2008
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing hospital readmissions and loss of functional ability in high risk older adults: a randomised controlled trial
Scientific title
An evaluation of the effectiveness of transitional care interventions, (including individual exercise programs, comprehensive discharge planning, and home and telephone follow-up care for 24 weeks from discharge) in preventing hospital readmissions and loss of functional ability in older adults at high risk of hospital readmission: a randomised controlled trial
Secondary ID [1] 283187 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Rio2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital readmissions and loss of functional ability in older adults at high risk of hospital readmission 3042 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3196 3196 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1. Gerontic Nurse (GN) comprehensive assessment within 72 hours of hospital admission, discharge planning, home visit within 72 hours from discharge, telephone follow-up care weekly for 4 weeks then monthly for 24 weeks post-discharge.

Intervention 2. Physiotherapist comprehensive assessment within 72 hours of hospital admission, individualised exercise program commencing within 72 hours of hospital admission.

Intervention 3. Gerontic Nurse (GN) and Physiotherapist comprehensive assessment within 72 hours of hospital admission, individualised exercise program commencing within 72 hours of hospital admission, discharge planning (GN), home visit within 72 hours from discharge (GN), telephone follow-up care weekly for 4 weeks then monthly for 24 weeks post-discharge (GN).
Intervention code [1] 2790 0
Prevention
Comparator / control treatment
Standard Treatment: routine assessments, discharge planning and follow-up care undertaken and organised by hospital staff. This follow-up care involves a follow-up appointment with either the hospital Outpatients Department Medical clinic, or their local General Practitioner, organisation of 'Home Help' (assistance with shopping and housework, Meals-on-Wheels) community services if the patient fits the criteria, and organisation of community nursing services and/or allied health services (e.g. physiotherapy, occupational therapy) if the patient has particular needs for these types of care following discharge.
Control group
Active

Outcomes
Primary outcome [1] 4082 0
Hospital readmissions and unplanned health service use (Emergency Department visits, emergency visits to General Practitioners or other health professionals)
Timepoint [1] 4082 0
4 weeks, 12 weeks and 24 weeks from discharge from hospital
Primary outcome [2] 4083 0
Functional Ability, as measured with Instrumental Activities of Daily Living Scale, Activities of Daily Living Scae, and Walking Impairment Questionnaire (Modified)
Timepoint [2] 4083 0
On admission to the study, then 4 weeks, 12 weeks, and 24 weeks following hospital discharge
Primary outcome [3] 4084 0
Cost effectiveness, using measures of cost of care, cost of unplanned health service use, costs related to decreased functional ability and loss of independence in activities of daily living
Timepoint [3] 4084 0
On admission to the study (baseline), 4 weeks, 12 weeks and 24 weeks from hospital discharge
Secondary outcome [1] 6875 0
Quality of Life, using the SF-12v2
Timepoint [1] 6875 0
On admission to the study, 4 weeks, 12 weeks, and 24 weeks from hospital discharge
Secondary outcome [2] 6876 0
Physical strength and endurance, measured with grip strength, Timed Get Up and Go Test, Berg Balance Scale, 6 metre walk test
Timepoint [2] 6876 0
On admission to the study, 4 weeks, 12 weeks and 24 weeks from hospital dishcarge
Secondary outcome [3] 6877 0
Psychosocial outcomes, as measured with the Geriatric Depression Scale, Medical Outcomes Study Social Support Scale and Chronic Disease Self-Efficacy Scales
Timepoint [3] 6877 0
On admission to the study, then 4 weeks, 12 weeks and 24 weeks from hospital discharge

Eligibility
Key inclusion criteria
1. Aged 65 years or older
2. Admitted to a hospital wards with a medical (i.e. non-surgical) diagnosis
3. Have at least one of the following known risk factors for hospital readmission:
a. aged 75 years or older
b. live alone
c. poor social support available at home
d. 2 or more hospital admissions within the previous 6 months
e. previous hopsitalisation in the past 30 days
f. moderate to severe functional impairment
g. history of depression
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to be contacted via telephone
2. Resident of a high care nursing home
3. Unable to speak or understand English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to commencement of the study a randomisation allocation sequence will be generated with a computerised randomisation program. A staff member not working on this project will then fill sealed opaque envelopes with the allocation sequence. A Research Assistant at the clnical site will determine if the patient is elibible for inclusion in the trial, then obtain informed consent and collect baseline data. THe research assistant will then open the sealed envelope to determine the participant's allocated group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2008
Actual
24/04/2008
Date of last participant enrolment
Anticipated
Actual
28/10/2010
Date of last data collection
Anticipated
Actual
14/04/2011
Sample size
Target
328
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 644 0
4101

Funding & Sponsors
Funding source category [1] 3292 0
Government body
Name [1] 3292 0
ARC Discovery Projects Grant
Country [1] 3292 0
Australia
Primary sponsor type
Individual
Name
Professor Mary Courtney
Address
Professor M. Courtney
Faculty of Health
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 2947 0
Individual
Name [1] 2947 0
Professor Helen Edwards
Address [1] 2947 0
Professor H. Edwards
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country [1] 2947 0
Australia
Other collaborator category [1] 261 0
Hospital
Name [1] 261 0
Professor Anne Chang, Mater Health Services
Address [1] 261 0
Professor Anne Chang
Centre for Nursing Research
Mater Health Services
Raymond Tce
South Brisbane QLD 4101
Country [1] 261 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5278 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 5278 0
Ethics committee country [1] 5278 0
Australia
Date submitted for ethics approval [1] 5278 0
Approval date [1] 5278 0
03/04/2008
Ethics approval number [1] 5278 0
Ref. No. 1173A

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

Contacts
Principal investigator
Name 28523 0
Prof Anne Chang
Address 28523 0
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove
Qld, 4059
Country 28523 0
Australia
Phone 28523 0
+61 0731383842
Fax 28523 0
Email 28523 0
[email protected]
Contact person for public queries
Name 11680 0
Anne Chang
Address 11680 0
Faculty of Health
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 11680 0
Australia
Phone 11680 0
+61 7 31383842
Fax 11680 0
+61 7 31383814
Email 11680 0
[email protected]
Contact person for scientific queries
Name 2608 0
Anne Chang
Address 2608 0
Faculty of Health
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 2608 0
Australia
Phone 2608 0
+61 7 31393842
Fax 2608 0
+61 7 31383814
Email 2608 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

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