Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Northumbria University
- Enrollment
- 996
- Locations
- 1
- Primary Endpoint
- Percentage of consenting users (denominator is number eligible)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Full app with all app components
Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.
Intervention: Self-management app with all intervention components (Behavioral)
Control minimal app with information component only
Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.
Intervention: Self-management app with Information component only (Behavioral)
Outcomes
Primary Outcomes
Percentage of consenting users (denominator is number eligible)
Time Frame: Through to completion of data collection period up to 6 months
Proportion of those who are eligible to participate that consented to take part in the study
ICECAP-A Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on "ICECAP-A" Quality of Life measure across participants
Number of people downloading the app
Time Frame: Through to completion of data collection period of up to 6 months
Total number of people who download the app from App Stores
Percentage of randomised users (denominator is number eligible)
Time Frame: Through to completion of data collection period up to 6 months
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 retained users (denominator is number consenting) at 10 weeks
Time Frame: Through to completion of data collection period up to 6 months
Proportion of those who those who consent to participate that complete all surveys at 10 weeks
ICECAP-A Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Completion rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey
Percentage of retained users (denominator is number consenting) at 5 weeks
Time Frame: Through to completion of data collection period up to 6 months
Proportion of those who those who consent to participate that complete all surveys at 5 weeks
ICECAP-A Completion rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey
MFIS-5 Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on the MFIS-5 fatigue impact measure, across participants
Percentage of eligible users (denominator is number downloading)
Time Frame: Through to completion of data collection period up to 6 months
Proportion of users who have downloaded the app that are eligible to participate
ICECAP-A Completion rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey
ICECAP-A Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale
ESSPRI Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on "ESSPRI" symptom severity measure across participants
ESSPRI Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
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) Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on the 100 point digital VAS across participants
Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety
Anxiety Digital VAS Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on the 100 point digital VAS across participants
MFIS-5 Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on the MFIS-5 fatigue impact measure, across participants
Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression
Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on the 100 point digital VAS across participants
Depression Digital VAS Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on depression VAS across participants
Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety
Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete all 8 questions of the SCI
Sleep Condition Index (SCI) Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on the SCI across participants
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on the SCI across participants
PAM-10 Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on the PAM-10 across participants
PAM-10 Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on the PAM-10 across participants
ESSPRI Completion Rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms).
ESSPRI Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
ESSPRI Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
MFIS-5 Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on the MFIS-5 fatigue impact measure, across participants
MFIS-5 Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
MFIS-5 Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression
Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete all 8 questions of the SCI
PAM-10 Completion Rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)
ESSPRI Completion Rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete all 3 questions of ESSPRI survey (assessing dryness, fatigue and pain symptoms).
ESSPRI Completion Rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms).
ESSPRI Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on "ESSPRI" symptom severity measure across participants
ESSPRI Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on "ESSPRI" symptom severity measure across participants
MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale
MFIS-5 Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression
Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on the 100 point digital VAS across participants
Depression Digital VAS Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on depression VAS across participants
Anxiety Digital VAS Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Average score on the 100 point digital VAS across participants
Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Sleep Condition Index (SCI) Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on the SCI across participants
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on the SCI across participants
Depression Digital VAS Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on depression VAS across participants
Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety
Anxiety Digital VAS Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on the 100 point digital VAS across participants
Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on the Anxiety digital VAS across participants
PAM-10 Standard Deviation of Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Standard deviation around Mean Score on the PAM-10 across participants
Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks
Time Frame: 10 weeks from date of consent
Percentage of those who consent to take part that complete all 8 questions of the SCI
Sleep Condition Index (SCI) Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Average score on the SCI across participants
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on the SCI across participants
PAM-10 Completion Rate (denominator is number consenting) at 0 weeks
Time Frame: 0 weeks from date of consent
Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)
PAM-10 Completion Rate (denominator is number consenting) at 5 weeks
Time Frame: 5 weeks from date of consent
Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)
PAM-10 Standard Deviation of Mean Score at 0 weeks
Time Frame: 0 weeks from date of consent
Standard deviation around Mean Score on the PAM-10 across participants
PAM-10 Mean Score at 5 weeks
Time Frame: 5 weeks from date of consent
Average score on the PAM-10 across participants
PAM-10 Standard Deviation of Mean Score at 10 weeks
Time Frame: 10 weeks from date of consent
Standard deviation around Mean Score on the PAM-10 across participants
User Demographics
Time Frame: 0 weeks from date of consent
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.
Secondary Outcomes
- Depth of app engagement(Interaction data will be collected continuously for up to 13 weeks for each participant.)
- Acceptability of app and study procedures(Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent)
- App user retention(Interaction data will be collected continuously for up to 13 weeks for each participant.)
- Duration of app engagement(Interaction data will be collected continuously for up to 13 weeks for each participant.)
- Frequency of app engagement(Interaction data will be collected continuously for up to 13 weeks for each participant.)