Pilot Feasibility Study of a Sjögren's Syndrome Self-management App
NCT ID: NCT04653935
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
996 participants
INTERVENTIONAL
2020-01-06
2021-07-31
Brief Summary
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Detailed Description
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The fully-remote evaluation will involve minimal contact with researchers. Potential participants will be recruited internationally online through social media and mailing lists for Sjogren's syndrome support groups. Adverts will direct people to download the self-management app on app stores (Apple App Store and Google Play). The app has been designed to automate all study procedures, by guiding users through the following processes: screening, informed consent, randomisation, and the collection of outcome data through in-app surveys sent at 0, 5, and 10 weeks. Users will be randomised to receive the full intervention or a control:
* Intervention group: full version of the app containing multiple behavioural components: Symptom and Lifestyle Information, Energy Management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.
* Control Group: minimal version of the app containing only the Symptom and Lifestyle Information component.
To pilot and assess the feasibility of the planned methodology, and inform the design of a future definitive randomised control trial of the app, the primary objectives of this study are to: characterise users (i.e. international recruitment and consent rates), and test screening, randomisation and data collection procedures (i.e. outcome measure completion rates and score variability). The secondary objectives are to explore app engagement patterns (using log data) and the acceptability of the study procedures and the app (using remote semi-structured interviews).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Full app with all app components
Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.
Self-management app with all intervention components
A behavioural self-management app, containing multiple cognitive- and behavioural self-management techniques for those living with Sjögren's syndrome. The intervention is comprised of several components and modules that holistically target several key symptoms: fatigue, sleep disturbances, chronic pain, and dryness. The app has been developed using user-centred methods, and is theory- and evidence-based.
Control minimal app with information component only
Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.
Self-management app with Information component only
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
Interventions
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Self-management app with all intervention components
A behavioural self-management app, containing multiple cognitive- and behavioural self-management techniques for those living with Sjögren's syndrome. The intervention is comprised of several components and modules that holistically target several key symptoms: fatigue, sleep disturbances, chronic pain, and dryness. The app has been developed using user-centred methods, and is theory- and evidence-based.
Self-management app with Information component only
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)
* Own an iPhone or Android smartphone
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Newcastle University
OTHER
Teesside University
OTHER
Versus Arthritis
OTHER
Northumbria University
OTHER
Responsible Party
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Principal Investigators
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Katie L Hackett, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Claire H McCallum, PhD
Role: STUDY_CHAIR
Northumbria University
Locations
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Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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Other Identifiers
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118742
Identifier Type: -
Identifier Source: org_study_id
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