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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Behavioral: Self-management app with all intervention components
* Behavioral: Self-management app with Information component only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full app with all app components<br>Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills. | Behavioral: Self-management app with all intervention components<br>* 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.<br>* Other names: Sjogo app;|
| Active Comparator: Control minimal app with information component only<br>Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components. | Behavioral: Self-management app with Information component only<br>* self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.<br>* Other names: Sjogo app_information only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of people downloading the app | Total number of people who download the app from App Stores | Through to completion of data collection period of up to 6 months | 
| Percentage of eligible users (denominator is number downloading) | Proportion of users who have downloaded the app that are eligible to participate | Through to completion of data collection period up to 6 months | 
| Percentage of consenting users (denominator is number eligible) | Proportion of those who are eligible to participate that consented to take part in the study | Through to completion of data collection period up to 6 months | 
| Percentage of randomised users (denominator is number eligible) | 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. | Through to completion of data collection period up to 6 months | 
| Percentage of retained users (denominator is number consenting) at 5 weeks | Proportion of those who those who consent to participate that complete all surveys at 5 weeks | Through to completion of data collection period up to 6 months | 
| Percentage of retained users (denominator is number consenting) at 10 weeks | Proportion of those who those who consent to participate that complete all surveys at 10 weeks | Through to completion of data collection period up to 6 months | 
| ICECAP-A Completion rate (denominator is number consenting) at 0 weeks | Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey | 0 weeks from date of consent | 
| ICECAP-A Completion rate (denominator is number consenting) at 5 weeks | Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey | 5 weeks from date of consent | 
| ICECAP-A Completion rate (denominator is number consenting) at 10 weeks | Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey | 10 weeks from date of consent | 
| ICECAP-A Mean Score at 0 weeks | Average score on ICECAP-A Quality of Life Measure across participants | 0 weeks from date of consent | 
| ICECAP-A Mean Score at 5 weeks | Average score on ICECAP-A Quality of Life Measure across participants | 5 weeks from date of consent | 
| ICECAP-A Mean Score at 10 weeks | Average score on ICECAP-A Quality of Life measure across participants | 10 weeks from date of consent | 
| ICECAP-A Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on ICECAP-A Quality of Life Measure across participants | 0 weeks from date of consent | 
| ICECAP-A Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on ICECAP-A Quality of Life Measure across participants | 5 weeks from date of consent | 
| ICECAP-A Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on ICECAP-A Quality of Life Measure across participants | 10 weeks from date of consent | 
| ESSPRI Completion Rate (denominator is number consenting) at 0 weeks | Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms). | 0 weeks from date of consent | 
| ESSPRI Completion Rate (denominator is number consenting) at 5 weeks | Percentage of those who consent to take part that complete all 3 questions of ESSPRI survey (assessing dryness, fatigue and pain symptoms). | 5 weeks from date of consent | 
| ESSPRI Completion Rate (denominator is number consenting) at 10 weeks | Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms). | 10 weeks from date of consent | 
| ESSPRI Mean Score at 0 weeks | Average score on ESSPRI symptom severity measure across participants | 0 weeks from date of consent | 
| ESSPRI Mean Score at 5 weeks | Average score on ESSPRI symptom severity measure across participants | 5 weeks from date of consent | 
| ESSPRI Mean Score at 10 weeks | Average score on ESSPRI symptom severity measure across participants | 10 weeks from date of consent | 
| ESSPRI Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on ESSPRI symptom severity measure across participants | 0 weeks from date of consent | 
| ESSPRI Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on ESSPRI symptom severity measure across participants | 5 weeks from date of consent | 
| ESSPRI Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on ESSPRI symptom severity measure across participants | 10 weeks from date of consent | 
| MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks | Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale | 0 weeks from date of consent | 
| MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks | Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale | 5 weeks from date of consent | 
| MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks | Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale | 10 weeks from date of consent | 
| MFIS-5 Mean Score at 0 weeks | Average score on the MFIS-5 fatigue impact measure, across participants | 0 weeks from date of consent | 
| MFIS-5 Mean Score at 5 weeks | Average score on the MFIS-5 fatigue impact measure, across participants | 5 weeks from date of consent | 
| MFIS-5 Mean Score at 10 weeks | Average score on the MFIS-5 fatigue impact measure, across participants | 10 weeks from date of consent | 
| MFIS-5 Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants | 0 weeks from date of consent | 
| MFIS-5 Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants | 5 weeks from date of consent | 
| MFIS-5 Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants | 10 weeks from date of consent | 
| 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 | 0 weeks from date of consent | 
| 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 | 5 weeks from date of consent | 
| 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 | 10 weeks from date of consent | 
| Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks | Average score on the 100 point digital VAS across participants | 0 weeks from date of consent | 
| Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks | Average score on the 100 point digital VAS across participants | 5 weeks from date of consent | 
| Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks | Average score on the 100 point digital VAS across participants | 10 weeks from date of consent | 
| Depression Digital VAS Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on depression VAS across participants | 0 weeks from date of consent | 
| Depression Digital VAS Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on depression VAS across participants | 5 weeks from date of consent | 
| Depression Digital VAS Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on depression VAS across participants | 10 weeks from date of consent | 
| 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 | 0 weeks from date of consent | 
| 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 | 5 weeks from date of consent | 
| 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 | 10 weeks from date of consent | 
| Anxiety Digital VAS Mean Score at 0 weeks | Average score on the 100 point digital VAS across participants | 0 weeks from date of consent | 
| Anxiety Digital VAS Mean Score at 5 weeks | Average score on the 100 point digital VAS across participants | 5 weeks from date of consent | 
| Anxiety Digital VAS Mean Score at 10 weeks | Average score on the 100 point digital VAS across participants | 10 weeks from date of consent | 
| Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on the Anxiety digital VAS across participants | 0 weeks from date of consent | 
| Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on the Anxiety digital VAS across participants | 5 weeks from date of consent | 
| Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on the Anxiety digital VAS across participants | 10 weeks from date of consent | 
| Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks | Percentage of those who consent to take part that complete all 8 questions of the SCI | 0 weeks from date of consent | 
| Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks | Percentage of those who consent to take part that complete all 8 questions of the SCI | 5 weeks from date of consent | 
| Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks | Percentage of those who consent to take part that complete all 8 questions of the SCI | 10 weeks from date of consent | 
| Sleep Condition Index (SCI) Mean Score at 0 weeks | Average score on the SCI across participants | 0 weeks from date of consent | 
| Sleep Condition Index (SCI) Mean Score at 5 weeks | Average score on the SCI across participants | 5 weeks from date of consent | 
| Sleep Condition Index (SCI) Mean Score at 10 weeks | Average score on the SCI across participants | 10 weeks from date of consent | 
| Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on the SCI across participants | 0 weeks from date of consent | 
| Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on the SCI across participants | 5 weeks from date of consent | 
| Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on the SCI across participants | 10 weeks from date of consent | 
| PAM-10 Completion Rate (denominator is number consenting) at 0 weeks | Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10) | 0 weeks from date of consent | 
| PAM-10 Completion Rate (denominator is number consenting) at 5 weeks | Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10) | 5 weeks from date of consent | 
| PAM-10 Completion Rate (denominator is number consenting) at 10 weeks | Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10) | 10 weeks from date of consent | 
| PAM-10 Mean Score at 0 weeks | Average score on the PAM-10 across participants | 0 weeks from date of consent | 
| PAM-10 Mean Score at 5 weeks | Average score on the PAM-10 across participants | 5 weeks from date of consent | 
| PAM-10 Mean Score at 10 weeks | Average score on the PAM-10 across participants | 10 weeks from date of consent | 
| PAM-10 Standard Deviation of Mean Score at 0 weeks | Standard deviation around Mean Score on the PAM-10 across participants | 0 weeks from date of consent | 
| PAM-10 Standard Deviation of Mean Score at 5 weeks | Standard deviation around Mean Score on the PAM-10 across participants | 5 weeks from date of consent | 
| PAM-10 Standard Deviation of Mean Score at 10 weeks | Standard deviation around Mean Score on the PAM-10 across participants | 10 weeks from date of consent | 
| User Demographics | 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. | 0 weeks from date of consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App user retention | Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs | Interaction data will be collected continuously for up to 13 weeks for each participant. | 
| Frequency of app engagement | The maximum, minimum and average number of times the app is launched | Interaction data will be collected continuously for up to 13 weeks for each participant. | 
| Duration of app engagement | The maximum, minimum and average length of time users interact with app | Interaction data will be collected continuously for up to 13 weeks for each participant. | 
| Depth of app engagement | The maximum, minimum and average number of times users interact with specific app features after launching the app | Interaction data will be collected continuously for up to 13 weeks for each participant. | 
| Acceptability of app and study procedures | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Smartphone, Autoimmune, Rheumatology