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Trial registered on ANZCTR


Registration number
ACTRN12617000921381
Ethics application status
Approved
Date submitted
5/06/2017
Date registered
22/06/2017
Date last updated
8/04/2019
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a smartphone app help older people with arthritis pain manage their pain better?: DigiTech Pain Project.
Scientific title
Feasibility and preliminary outcome evaluation of a pain self-management app intervention among older people living with arthritic pain.
Secondary ID [1] 291895 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritic Condition 303188 0
Condition category
Condition code
Musculoskeletal 302628 302628 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention details
The RAISE App has been designed by the collaborative effort of Rheumatology department of St James hospital in Ireland, and Arthritis Ireland for the self-management management of Arthritic pain [53]. The RAISE App features could be broadly classed as encompassing:
• Assessment and documentation: RAISE offers an option to assess pain in a 0-5 Numeric Rating Scale (NRS) and keeps a time-stamped record of the NRS score. This pain intensity scale can be used as frequently as the user desires. Users can also record their activity level on a 0-5 NRS; and
Pain self-management education: The RAISE app provides education on a range of different topics relating to pain self-management such as provision of education on pain/pain self-management process, medication use, communication with health professionals and pain related problem solving. Information on fatigue, sleep, and psychological issues management. CBT pain management instruction on relaxation, goal-setting, and activity pacing (20-30 minutes session). Videos of stretching, isotonic and aerobic exercise with warm-up and cool-down stages. Duration and frequency of exercise is also indicated.
Intervention delivery:
Consenting older participants will be met for a face-to-face session conducted by the PhD student undertaking this study (Ms Bhattarai), who is an experienced clinical trials nurse and a research assistant. This session will be carried out at a mutually convenient location- which includes any one of the following: the university of Notre Dame, participant’s home, or at a local library. The session is estimated to take approximately 45 minutes. The session will be aimed at providing all the relevant intervention details to the participants and also to organise the App download to their device. The baseline (Day 0) data collection will also be carried out during this meeting using a collection of questionnaires. A wireless enabled device will be purchased for the purpose of this trial that will be used for downloading the App to the face-to-face meeting participant’s device. If a face-to-face meeting is not feasible; and the participant is willing and able to use their own wireless or mobile internet for the App download, this session will be carried out over the phone (tele-meeting).
During this session participants will be provided a brief training on how to use the intervention App while providing a detailed demonstration of the App features. As the RAISE App features clear menu structure and simplistic user interface, it is expected that the participants will be able to use this app following a brief training. Participants will be advised to use the app however they want throughout the trial period (i.e the use of the app will not be prescribed).
In addition, participants will be provided with a contact card with the name and contact number of the research team and instruction to contact if assistance is needed. The contact card will be posted out to those taking part in the tele-meeting. The meeting will then be summarised, and participant will be instructed to use the app for four weeks (Day 1-14). Participants will be contacted again on Day 15 for the follow-up data collection. This data collection session is expected take approximately 30 minutes and will be carried out over the phone or face-to-face whichever is convenient for the participant.

Reference: Bhattarai, P., T.R.O. Newton-John, and J.L. Phillips, Quality and Usability of Arthritic Pain Self-Management Apps for Older Adults: A Systematic Review. Pain Medicine, 2017.
Intervention code [1] 298011 0
Treatment: Other
Intervention code [2] 298278 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302036 0
Feasibility:
Evaluated measuring the recruitment, refusal, and attrition rates; and patterns of missing data.
The recruitment, refusal, and attrition rates are measured by evaluating the screening recruitment and participant log which will be maintained by the research team throughout the study period.
The pattern of missing data will be assessed by evaluating the paper based data collected before the intervention (Day 0/pre-test) and after the intervention (Day 29/post test).
Timepoint [1] 302036 0
At the end of intervention period.
Secondary outcome [1] 334598 0
Pain severity and interference, measured using the Brief Pain inventory- Short form.
Timepoint [1] 334598 0
Before the intervention (Day 0/pre-test), and after the intervention (Day 15/post-test).
Secondary outcome [2] 335705 0
Pain self-efficacy, measured using the Pain Self-Efficacy Questionnaire- Short form.
Timepoint [2] 335705 0
Before the intervention (Day 0/pre-test), and after the intervention (Day 15/post-test).
Secondary outcome [3] 335706 0
Online technology self-efficacy, measured using the Online Technology Self-Efficacy Scale.
Timepoint [3] 335706 0
Before the intervention (Day 0/pre-test), and after the intervention (Day 15/post-test).

Eligibility
Key inclusion criteria
• People aged 65 years or over living in the community,
• presence of arthritic pain for 3 or more months,
• ability to read and write in English,
• ownership of a smartphone/tablet-computer, and
• ability to give written informed consent.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for older people:
• Presence of cancer pain
• under end-of-life care pathways, and
• people living in institutional homes receiving clinical care from health professionals such as a nurse.

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)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-post-test design
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to synthesize socio-demographic data of the participants. Frequencies and percentages will be reported for categorical variables, normally distributed continuous variables will be presented as mean and standard deviations, and median and inter-quartile range will be reported for non-normally distributed continuous variables. Participant’s pre-test self-reported pain data (pain intensity and pain interference), pain self-efficacy, and online technology self-efficacy will be compared with their post-test reports. A paired t-test analysis will be conducted to compare the pre-test reports with post-test so as to identify any statistically significant differences. The paired t-test is an appropriate statistical test for when there is just one observation for each combination of nominal values, i.e. before and after the intervention. The difference between the two time points will be considered significant if the p value is less that 0.05 (p<0.05). The data analysis results will be presented in tabular and/or graphical form as appropriate.
Additional information regarding sample size and outcomes:
We consulted with a senior statistician and referred to relevant literature with regards to sample size. As this study is a Phase I feasibility study which is a non-randomised, non-stratified, pilot study to gauge acceptability of this treatment modality with older adults, a sample size calculation was considered to be inappropriate. However, based on comparable feasibility studies in the literature, we are aiming to recruit 30 participants for the study.
Further we also note that the outcomes this feasibility study aims to measure are preliminary outcomes only The preliminary outcomes data is expected to indicate if there is any evidence of likely effect of the intervention on the outcomes of interest.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2017
Actual
7/08/2017
Date of last participant enrolment
Anticipated
15/12/2018
Actual
17/08/2018
Date of last data collection
Anticipated
30/12/2018
Actual
31/08/2018
Sample size
Target
30
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 296398 0
Government body
Name [1] 296398 0
Australian Government: Department of Education and training
Country [1] 296398 0
Australia
Primary sponsor type
Individual
Name
Professor Jane L Phillips
Address
ImPACCT – Improving Palliative, Aged and Chronic Care through Clinical and Translational Research,
University of Technology Sydney
Level 3, 235 Jones St,
Ultimo NSW 2007
(PO Box 123)
Country
Australia
Secondary sponsor category [1] 295339 0
Individual
Name [1] 295339 0
Dr Toby Newton-John
Address [1] 295339 0
Graduate School of Health
University of Technology, Sydney
Level 4, Building 7, 67
Thomas St, Ultimo NSW 2007
(PO Box 123)
Country [1] 295339 0
Australia
Secondary sponsor category [2] 295342 0
Individual
Name [2] 295342 0
Ms Priyanka Bhattarai
Address [2] 295342 0
The University of Notre Dame Australia
School of Nursing
Cnr Broadway and Abercrombie St
Broadway NSW 2007 Australia
(PO Box 944)
Country [2] 295342 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297627 0
The University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 297627 0
Ethics committee country [1] 297627 0
Australia
Date submitted for ethics approval [1] 297627 0
04/04/2017
Approval date [1] 297627 0
06/06/2017
Ethics approval number [1] 297627 0
017049s

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1774 1774 0 0
/AnzctrAttachments/372895-Ethics Approval_DigiTech Pain Project. 6.6.2017 .pdf

Contacts
Principal investigator
Name 74638 0
Prof Jane L Phillips
Address 74638 0
University of Technology Sydney
Level 3, 235 Jones St,
Ultimo NSW 2007
(PO Box 123)
Country 74638 0
Australia
Phone 74638 0
+61 2 9514 4862
Fax 74638 0
Email 74638 0
jane.phillips@uts.edu.au
Contact person for public queries
Name 74639 0
Priyanka Bhattarai
Address 74639 0
The University of Notre Dame Australia
School of Nursing | Cnr Broadway and Abercrombie St
(PO Box 944)
Broadway NSW 2007 Australia
Country 74639 0
Australia
Phone 74639 0
+61 423 882 700
Fax 74639 0
Email 74639 0
Priyanka.Bhattarai1@my.nd.edu.au
Contact person for scientific queries
Name 74640 0
Priyanka Bhattarai
Address 74640 0
The University of Notre Dame Australia
School of Nursing | Cnr Broadway and Abercrombie St
(PO Box 944)
Broadway NSW 2007 Australia
Country 74640 0
Australia
Phone 74640 0
+61423882700
Fax 74640 0
Email 74640 0
Priyanka.Bhattarai1@my.nd.edu.au

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?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    372895-(Uploaded-06-04-2019-16-02-49)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility evaluation of a pain selfmanagement app-based intervention among older people living with arthritic pain: Study protocol.2019https://dx.doi.org/10.1186/s40814-019-0442-5
N.B. These documents automatically identified may not have been verified by the study sponsor.