NCT04653935

Pilot Feasibility Study of a Sjögren's Syndrome Self-management App

Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 996 (actual)
• Sponsor: Northumbria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the feasibility of a fully remote effectiveness evaluation of a self-management smartphone application for those with Sjogren's syndrome.

Detailed description

The aim of this study is to pilot and assess the feasibility of a fully remote effectiveness evaluation of a smartphone self-management app for those living with Sjogren's syndrome. 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

• Sjogren's Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Self-management app with Information component only	self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.

Timeline

• Start date: 2020-01-06
• Primary completion: 2021-05-01
• Completion: 2021-07-01
• First posted: 2020-12-04
• Last updated: 2021-04-15

Locations

1 site across 1 country: United Kingdom