Clinical trial NCT04653935: Pilot Feasibility Study of a Sjögren's Syndrome Self-management App
Official title: Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sjogren's Syndrome
Keywords: Self-management
Smartphone
Autoimmune
Rheumatology
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Newcastle University
name: Teesside University
name: Versus Arthritis
First posted: 2020-12-04
Enrollment: 996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of people downloading the app
timeFrame: Through to completion of data collection period of up to 6 months
measure: Percentage of eligible users (denominator is number downloading)
timeFrame: Through to completion of data collection period up to 6 months
measure: Percentage of consenting users (denominator is number eligible)
timeFrame: Through to completion of data collection period up to 6 months
measure: Percentage of randomised users (denominator is number eligible)
timeFrame: Through to completion of data collection period up to 6 months
measure: Percentage of retained users (denominator is number consenting) at 5 weeks
timeFrame: Through to completion of data collection period up to 6 months
measure: Percentage of retained users (denominator is number consenting) at 10 weeks
timeFrame: Through to completion of data collection period up to 6 months
measure: ICECAP-A Completion rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: ICECAP-A Completion rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: ICECAP-A Completion rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: ICECAP-A Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: ICECAP-A Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: ICECAP-A Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: ICECAP-A Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: ICECAP-A Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: ICECAP-A Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: ESSPRI Completion Rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: ESSPRI Completion Rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: ESSPRI Completion Rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: ESSPRI Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: ESSPRI Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: ESSPRI Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: ESSPRI Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: ESSPRI Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: ESSPRI Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: MFIS-5 Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: MFIS-5 Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: MFIS-5 Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: MFIS-5 Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: MFIS-5 Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: MFIS-5 Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Depression Digital VAS Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Depression Digital VAS Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Depression Digital VAS Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Anxiety Digital VAS Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Anxiety Digital VAS Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Anxiety Digital VAS Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Sleep Condition Index (SCI) Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Sleep Condition Index (SCI) Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Sleep Condition Index (SCI) Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: PAM-10 Completion Rate (denominator is number consenting) at 0 weeks
timeFrame: 0 weeks from date of consent
measure: PAM-10 Completion Rate (denominator is number consenting) at 5 weeks
timeFrame: 5 weeks from date of consent
measure: PAM-10 Completion Rate (denominator is number consenting) at 10 weeks
timeFrame: 10 weeks from date of consent
measure: PAM-10 Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: PAM-10 Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: PAM-10 Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: PAM-10 Standard Deviation of Mean Score at 0 weeks
timeFrame: 0 weeks from date of consent
measure: PAM-10 Standard Deviation of Mean Score at 5 weeks
timeFrame: 5 weeks from date of consent
measure: PAM-10 Standard Deviation of Mean Score at 10 weeks
timeFrame: 10 weeks from date of consent
measure: User Demographics
timeFrame: 0 weeks from date of consent
Secondary outcomes:
measure: App user retention
timeFrame: Interaction data will be collected continuously for up to 13 weeks for each participant.
measure: Frequency of app engagement
timeFrame: Interaction data will be collected continuously for up to 13 weeks for each participant.
measure: Duration of app engagement
timeFrame: Interaction data will be collected continuously for up to 13 weeks for each participant.
measure: Depth of app engagement
timeFrame: Interaction data will be collected continuously for up to 13 weeks for each participant.
measure: Acceptability of app and study procedures
timeFrame: Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne And Wear
Study officials:
affiliation: Northumbria University
name: Katie L Hackett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northumbria University
name: Claire H McCallum, PhD
role: STUDY_CHAIR
References: