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

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

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).

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

Users receive app that contains only Symptom and Lifestyle information, and cannot see other 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 for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.

Proportion of those who are eligible to participate that complete all surveys at week 0 and then automatically randomised to one of two app versions.

Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms).

Percentage of those who consent to take part that complete all 3 questions of ESSPRI survey (assessing dryness, fatigue and pain symptoms).

Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms).

Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale

Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale

Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale

Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks

Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression

Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks

Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression

Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks

Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression

Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks

Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety

Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks

Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety

Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks

Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety

Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)

Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)

Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)

Investigator-developed questionnaire asking users to enter their gender (M/F/Other/Prefer not to say), age (years), whether users have primary or secondary Sjogren's syndrome, number of years since diagnosis, country of residence, and any other conditions users wish to report.

Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs

The maximum, minimum and average number of times users interact with specific app features after launching the app

All users will be invited to participate in a remote qualitative interview (up to 60 minutes). We do not expect that all participants will take part, and aim to recruit n=20 (10 in experimental group, 10 in control group). Interested users will be contacted via email to consent and arrange a suitable interview time. Semi-structured interviews will explore acceptability of the app and study procedures (i.e. affective attitude, burden, perceived effectiveness of the app, ethicality, app coherence, and opportunity costs) and usability of the app (informed by items on the System Usability Scale.

Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent

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

Data sets (including answers to questionnaires, smartphone interaction data, and qualitative interview data) may be used to support future student projects at Northumbria University, however these datasets will be fully anonymised before being shared.