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

Northumbria University

Status: Unknown

Conditions: Sjogren's Syndrome

Treatments: Behavioral: Self-management app with Information component only; Behavioral: Self-management app with all intervention components

Study type: Interventional

Funder types: Other

Identifiers

NCT04653935

118742

Details and patient eligibility

About

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

Full 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).

Enrollment: 996 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years of age
• Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)
• Own an iPhone or Android smartphone

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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996 participants in 2 patient groups

Full app with all app components

Experimental group

Description:

Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.

Treatment:

Behavioral: Self-management app with all intervention components

Control minimal app with information component only

Active Comparator group

Description:

Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.

Treatment:

Behavioral: Self-management app with Information component only