Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001223628
Ethics application status
Approved
Date submitted
19/10/2023
Date registered
28/11/2023
Date last updated
11/06/2024
Date data sharing statement initially provided
28/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The "Osteoarthritis (OA) Coach" feasibility study
Scientific title
Evaluation of the usability of the "OA Coach" mobile application for adults aged 45 and over with activity-related knee pain: a feasibility study
Secondary ID [1] 310817 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 331807 0
Condition category
Condition code
Musculoskeletal 328555 328555 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to use the "OA Coach" mobile application, which includes educational modules on topics related to osteoarthritis management

Each module will be provided in the format of a short article and resource library at the end with links to existing Youtube videos or podcast episodes on the topic. A summary of the modules is provided below.

Module 1: Weight loss
1.1.1 Understanding weight
1.1.2 Benefits of weight loss
1.1.3 Navigating weight loss.

1.2.1 Digital tools for managing weight loss

1.3.1 Where to get expert help

Module 2: Sleep and osteoarthritis
2.1.1 What is sleep?
2.1.2 Benefits of sleep
2.1.3 Tips for improving sleep

2.2.1 Digital tools for sleep

2.3.1 Where to get expert help

Module 3: Mood
3.1.1 Understanding mood
3.1.2 The interplay of mood and osteoarthritis
3.1.3 Benefits of a good mood

3.2.1 Digital tools for mood

3.3.1 Where to get expert help

Module 4: Flare management

Participants will also receive an activity tracker (Fitbit) that will be used to track their step count and sleep. Participants will be asked to use the app daily (total time up to participant discretion) for a total of 6 weeks. We will use app analytics, as well as Fitibit data (step counts) to monitor adherence to the intervention.
Intervention code [1] 327229 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336361 0
Usability of the OA Coach mobile application.
Timepoint [1] 336361 0
6 weeks post-baseline
Secondary outcome [1] 428015 0
Average knee pain over the past week
Timepoint [1] 428015 0
Baseline and 6-weeks post-baseline
Secondary outcome [2] 428333 0
Physical activity
Timepoint [2] 428333 0
Baseline and 6-weeks post-baseline
Secondary outcome [3] 428334 0
Time asleep
Timepoint [3] 428334 0
Baseline and 6-weeks post-baseline
Secondary outcome [4] 428341 0
Feelings of depression
Timepoint [4] 428341 0
Baseline and 6-weeks post-baseline
Secondary outcome [5] 428342 0
Sleep quality and disturbances
Timepoint [5] 428342 0
Baseline and 6-weeks post-baseline
Secondary outcome [6] 428343 0
Technology self-efficacy
Timepoint [6] 428343 0
Baseline and 6-weeks post-baseline
Secondary outcome [7] 428354 0
Feelings of social isolation; feelings of co-presence with health providers (composite measure)
Timepoint [7] 428354 0
6 weeks post-baseline
Secondary outcome [8] 429303 0
Feelings of anxiety
Timepoint [8] 429303 0
Baseline and 6-weeks post-baseline
Secondary outcome [9] 429304 0
Feelings of stress
Timepoint [9] 429304 0
Baseline and 6-weeks post-baseline

Eligibility
Key inclusion criteria
• Aged greater or equal to 45 years
• Activity related knee pain greater or equal to 4 on a 0 to 10 numerical rating scale (NRS)
• No morning stiffness or of short duration (less than 30 minutes) or a diagnosis of knee osteoarthritis from a health professional or x-ray
• Ownership of a smart phone with internet access
• Ability to communicate in English
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will not be eligible to participate if they have co-existing inflammatory arthritis, history of total knee preplacement, or any serious medical condition that would prevent them in taking part in the physical activity component of the mobile app.

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
8/03/2024
Date of last participant enrolment
Anticipated
12/02/2024
Actual
16/04/2024
Date of last data collection
Anticipated
26/06/2024
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25886 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 41719 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 315057 0
Charities/Societies/Foundations
Name [1] 315057 0
Lenity Australia
Country [1] 315057 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW, 2050
Country
Australia
Secondary sponsor category [1] 317083 0
None
Name [1] 317083 0
Address [1] 317083 0
Country [1] 317083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314011 0
Northern Sydney Local Health District Ethics Committee
Ethics committee address [1] 314011 0
Ethics committee country [1] 314011 0
Australia
Date submitted for ethics approval [1] 314011 0
25/10/2023
Approval date [1] 314011 0
23/11/2023
Ethics approval number [1] 314011 0
2023/ETH02288

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

Contacts
Principal investigator
Name 130114 0
Dr Vicky Duong
Address 130114 0
Level 10 Kolling Building, Reserve Road, Royal North Shore Hospital, St Leonards 2065, New South Wales
Country 130114 0
Australia
Phone 130114 0
+61 413047483
Fax 130114 0
Email 130114 0
[email protected]
Contact person for public queries
Name 130115 0
Vicky Duong
Address 130115 0
Level 10 Kolling Building, Reserve Road, Royal North Shore Hospital, St Leonards 2065, New South Wales
Country 130115 0
Australia
Phone 130115 0
+61 413047483
Fax 130115 0
Email 130115 0
[email protected]
Contact person for scientific queries
Name 130116 0
Vicky Duong
Address 130116 0
Level 10 Kolling Building, Reserve Road, Royal North Shore Hospital, St Leonards 2065, New South Wales
Country 130116 0
Australia
Phone 130116 0
+61 413047483
Fax 130116 0
Email 130116 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.