Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000715572
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
10/07/2015
Date last updated
30/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a telephone support service for older patients to improve quality of life after discharge from the emergency department.
Scientific title
Volunteer-peer telephone support for older patients to improve quality of life after discharge from the emergency department - a feasibility study.
Secondary ID [1] 286955 0
Nil known
Universal Trial Number (UTN)
U1111-1171-4018
Trial acronym
HOspitals and patients WoRking in Unity - The HOW R U study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptoms of depression 295406 0
loneliness 295407 0
social isolation 295523 0
Condition category
Condition code
Mental Health 295663 295663 0 0
Other mental health disorders
Public Health 295664 295664 0 0
Health service research
Mental Health 295835 295835 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a volunteer-peer telephone service that provides emotional and social support, together with social stimulation and informal guidance about strategies that might help address social isolation and loneliness.
Each telephone support session will be approximately 30 minutes, and will be delivered to participants once per week over a three month period (up to 12 telephone support calls).
The telephone support sessions will be delivered by hospital volunteers who are trained to help support patients and families during an acute hospital admission or emergency department visit. Each session will be unstructured and participant-directed, however participants will be asked to describe any changes since the previous call, the outcomes of any planned actions, and agree on new social goals. Any medical issues will be directed to the patient’s GP.
Telephone call logs will record the dates, times and length of each call, and the number of attempts required to make contact with the participant on each occasion. The content of calls made will be described using a simple template. Participant drop-outs and their reasons for doing so will also be recorded. Random audits of the telephone calls and the call logs will ensure a standard approach is being used and fidelity of the intervention.
Intervention code [1] 292157 0
Lifestyle
Intervention code [2] 292158 0
Treatment: Other
Comparator / control treatment
This is an uncontrolled pilot study that will examine the acceptability and feasibility of providing the volunteer-peer telephone support to the study cohort.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295368 0
perceived helpfulness of the peer support telephone service will be assessed by participant feedback questionnaire designed specifically for this study.
Timepoint [1] 295368 0
3 months after commencement of the intervention
Secondary outcome [1] 315438 0
mood, using the Geriatric Depression Scale - 5 item (GDS-5)
Timepoint [1] 315438 0
immediately prior to, and 3 months after commencement of the intervention
Secondary outcome [2] 315439 0
health-related quality of life, using EQ-5D-5L and EQ VAS
Timepoint [2] 315439 0
immediately prior to, and 3 months after commencement of the intervention
Secondary outcome [3] 315440 0
loneliness, using the UCLA 3 Item Loneliness Scale
Timepoint [3] 315440 0
immediately prior to, and 3 months after commencement of the intervention

Eligibility
Key inclusion criteria
Community-dwelling men and women, aged 70 years or more, who attend the Emergency Department (ED), and screen positive for symptoms of social isolation, depression and/or loneliness, with the Social Isolation Index, Geriatric Depression Scale–5 items (GDS-5) and/or UCLA 3-item Loneliness Scale
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients triaged in ED as category 1 or 2 level of urgency, or requiring surgery; living in nursing care homes; receiving end-of life care or likely to be approaching end-of-life within 12 months using the Supportive Care and Palliative Care Indicators Tool (SPICT) criteria; with moderate to severe cognitive impairment: Montreal Cognitive Assessment <18 (MoCA); with a confirmed diagnosis of dementia or severe mental illness such as schizophrenia or psychosis; or an inability or unwillingness to communicate by telephone

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is not a randomised controlled trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
this is a pragmatic uncontrolled feasibility study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used, alongside thematic analysis of participants' experiences.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/11/2015
Actual
19/11/2015
Date of last participant enrolment
Anticipated
18/11/2016
Actual
7/07/2016
Date of last data collection
Anticipated
31/10/2016
Actual
5/10/2016
Sample size
Target
50
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3953 0
The Alfred - Prahran
Recruitment hospital [2] 3954 0
Cabrini Hospital - Malvern - Malvern

Funding & Sponsors
Funding source category [1] 291513 0
Hospital
Name [1] 291513 0
Alfred Health
Country [1] 291513 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Public Health and Preventive Medicine
Level 6
99 Commercial Road
Melbourne
Victoria 3004
Country
Australia
Secondary sponsor category [1] 290194 0
Hospital
Name [1] 290194 0
Alfred Health
Address [1] 290194 0
55 Commercial Road
Melbourne
Victoria 3004
Country [1] 290194 0
Australia
Other collaborator category [1] 278503 0
Hospital
Name [1] 278503 0
Cabrini Health
Address [1] 278503 0
183 Wattletree Road
Malvern
Victoria 3144
Country [1] 278503 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293054 0
The Alfred Research and Ethics Unit
Ethics committee address [1] 293054 0
55 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 293054 0
Australia
Date submitted for ethics approval [1] 293054 0
02/09/2015
Approval date [1] 293054 0
07/10/2015
Ethics approval number [1] 293054 0
432/15
Ethics committee name [2] 293055 0
Cabrini HREC
Ethics committee address [2] 293055 0
183 Wattletree Road
Malvern
Victoria 3144
Ethics committee country [2] 293055 0
Australia
Date submitted for ethics approval [2] 293055 0
16/10/2015
Approval date [2] 293055 0
Ethics approval number [2] 293055 0
Ethics committee name [3] 293056 0
Monash University HREC
Ethics committee address [3] 293056 0
Monash Research Office
Monash University - Clayton Campus
151 Wellington Road
Clayton
Victoria, 3800
Ethics committee country [3] 293056 0
Australia
Date submitted for ethics approval [3] 293056 0
22/10/2015
Approval date [3] 293056 0
Ethics approval number [3] 293056 0

Summary
Brief summary
to test the feasibility and acceptability of HOW R U, an innovative volunteer-peer telephone-support intervention designed to support older vulnerable people after hospitalisation with the aim of improving their quality of life and reducing their risk of avoidable re-attendance and hospitalisation.

Hypothesis: Volunteer-peer telephone-support will help reduce symptoms of social isolation, loneliness and depressive feelings, through an improvement in mood and quality of life.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 585 585 0 0
/AnzctrAttachments/368803-Alfred 432-15 Ethics approval certificate 7-Oct-2015.pdf

Contacts
Principal investigator
Name 58270 0
Dr Judy Lowthian
Address 58270 0
School of Public Health and Preventive Medicine
Faculty of Medicine, Nursing and Health Sciences
Monash University
Level 6, Alfred Centre
99 Commercial Road
Melbourne
Victoria 3004
Country 58270 0
Australia
Phone 58270 0
+61 3 9903 0360
Fax 58270 0
Email 58270 0
[email protected]
Contact person for public queries
Name 58271 0
Judy Lowthian
Address 58271 0
School of Public Health and Preventive Medicine
Faculty of Medicine, Nursing and Health Sciences
Monash University
Level 6, Alfred Centre
99 Commercial Road
Melbourne
Victoria 3004
Country 58271 0
Australia
Phone 58271 0
+61 3 9903 0360
Fax 58271 0
Email 58271 0
[email protected]
Contact person for scientific queries
Name 58272 0
Judy Lowthian
Address 58272 0
School of Public Health and Preventive Medicine
Faculty of Medicine, Nursing and Health Sciences
Monash University
Level 6, Alfred Centre
99 Commercial Road
Melbourne
Victoria 3004
Country 58272 0
Australia
Phone 58272 0
+61 3 9903 0360
Fax 58272 0
Email 58272 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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