Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000975998
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
30/09/2020
Date last updated
17/12/2020
Date data sharing statement initially provided
30/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a volunteer-peer telephone support programme - A COVID-19 response
Scientific title
Feasibility and acceptability of a volunteer-peer telephone support programme for individuals affected by COVID-19
Secondary ID [1] 302147 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HOspitals and patients WoRking in Unity Care Transition Program (HOW-R-U? CTP)
Linked study record
ACTRN12615000715572 is the pilot of this study

Health condition
Health condition(s) or problem(s) studied:
symptoms of depression 318782 0
loneliness 318997 0
social isolation 318998 0
COVID-19 318999 0
Condition category
Condition code
Mental Health 316797 316797 0 0
Depression
Mental Health 316798 316798 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with weekly individual social telephone calls of approximately 20-40 minutes duration, by volunteers who are supported by psychologists. Calls are social in nature, not clinical, and topics for discussion will be driven by study participants. These calls will occur for approximately 12 weeks, and will be logged at the conclusion of each call.
Intervention code [1] 318445 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324911 0
Feasibility of the intervention, assessed using process data collected throughout the study e.g. participant and volunteer recruitment, participant and volunteer retention, number of calls delivered as recorded in the study database
Timepoint [1] 324911 0
Post-intervention (12 weeks)
Primary outcome [2] 325071 0
Acceptability of the intervention assessed using participant feedback questionnaire and one-on-one structured interviews designed specifically for this study and conducted over the phone.
Timepoint [2] 325071 0
Post-intervention (12 weeks)
Secondary outcome [1] 386175 0
Feelings of social isolation assessed using the Lubben Social Network Scale
Timepoint [1] 386175 0
Post-intervention (12 weeks)
Secondary outcome [2] 386730 0
Feelings of loneliness assessed using the UCLA-3 item
Timepoint [2] 386730 0
Post-intervention (12 weeks)
Secondary outcome [3] 386731 0
Feelings of depression assessed using the Patient Health Questionnaire-9 item (PHQ-9)
Timepoint [3] 386731 0
Post-intervention (12 weeks)

Eligibility
Key inclusion criteria
Community-dwelling individuals aged 18 or over from Northern Health with a) a diagnosis of COVID-19, or are close contacts of diagnosed cases, or b) accessing Northern Health community programs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moderate to severe cognitive impairment and/or a confirmed diagnosis of dementia; a diagnosis of severe mental illness such as schizophrenia or psychosis; and participants whose preferred language is other than English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306572 0
Government body
Name [1] 306572 0
Better Care Victoria
Country [1] 306572 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bolton Clarke
Address
347 Burwood Hwy, Burwood East VIC 3151
Country
Australia
Secondary sponsor category [1] 307095 0
Hospital
Name [1] 307095 0
Northern Hospital
Address [1] 307095 0
185 Cooper St, Epping VIC 3076
Country [1] 307095 0
Australia
Secondary sponsor category [2] 307096 0
Charities/Societies/Foundations
Name [2] 307096 0
Friends for Good
Address [2] 307096 0
247 Flinders Ln, Melbourne VIC 3000
Country [2] 307096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306757 0
Bolton Clarke Human Research Ethics Committe
Ethics committee address [1] 306757 0
347 Burwood Hwy, Burwood East VIC 3151
Ethics committee country [1] 306757 0
Australia
Date submitted for ethics approval [1] 306757 0
09/07/2020
Approval date [1] 306757 0
24/07/2020
Ethics approval number [1] 306757 0
170029
Ethics committee name [2] 306758 0
Northern Health Human Research Ethics Committe
Ethics committee address [2] 306758 0
185 Cooper St, Epping VIC 3076
Ethics committee country [2] 306758 0
Australia
Date submitted for ethics approval [2] 306758 0
25/08/2020
Approval date [2] 306758 0
26/08/2020
Ethics approval number [2] 306758 0
68220

Summary
Brief summary
This project aims to implement and evaluate the HOW-R-U? telephone peer support program to address social isolation, loneliness and depressive feelings in a COVID-19 affected cohort served by Northern Health. This project will provide supportive telephone calls in the time after being diagnosed with COVID-19, or working and living with those with COVID-19, which we hypothesise will help improve these feelings of isolation, loneliness and depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104918 0
Prof Judy Lowthian
Address 104918 0
Bolton Clarke Research Institute, Bolton Clarke, Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country 104918 0
Australia
Phone 104918 0
+61 412 116 571
Fax 104918 0
Email 104918 0
[email protected]
Contact person for public queries
Name 104919 0
Dr Marissa Dickins
Address 104919 0
Bolton Clarke Research Institute, Bolton Clarke, Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country 104919 0
Australia
Phone 104919 0
+61439043501
Fax 104919 0
Email 104919 0
[email protected]
Contact person for scientific queries
Name 104920 0
Dr Marissa Dickins
Address 104920 0
Bolton Clarke Research Institute, Bolton Clarke, Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country 104920 0
Australia
Phone 104920 0
+61439043501
Fax 104920 0
Email 104920 0
[email protected]

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


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.