An interventional study of Self-management app with all intervention components and Self-management app with Information component only in Sjogren's Syndrome, sponsored by Northumbria University. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Northumbria University · Not applicable, Interventional, and Treatment
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:
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).
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's enrollment of 996 is above the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.
Behavioral: Self-management app with Information component only
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.
Also known as: Sjogo app
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
Also known as: Sjogo app_information only
Number of people downloading the app
Total number of people who download the app from App Stores
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 weeks from date of consent
ICECAP-A Mean Score at 0 weeks
Average score on "ICECAP-A" Quality of Life Measure across participants
Time frame: 0 weeks from date of consent
ICECAP-A Mean Score at 5 weeks
Average score on "ICECAP-A" Quality of Life Measure across participants
Time frame: 5 weeks from date of consent
ICECAP-A Mean Score at 10 weeks
Average score on "ICECAP-A" Quality of Life measure across participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 10 weeks from date of consent
ESSPRI Mean Score at 0 weeks
Average score on "ESSPRI" symptom severity measure across participants
Time frame: 0 weeks from date of consent
ESSPRI Mean Score at 5 weeks
Average score on "ESSPRI" symptom severity measure across participants
Time frame: 5 weeks from date of consent
ESSPRI Mean Score at 10 weeks
Average score on "ESSPRI" symptom severity measure across participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 weeks from date of consent
MFIS-5 Mean Score at 0 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
Time frame: 0 weeks from date of consent
MFIS-5 Mean Score at 5 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
Time frame: 5 weeks from date of consent
MFIS-5 Mean Score at 10 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 weeks from date of consent
Anxiety Digital VAS Mean Score at 0 weeks
Average score on the 100 point digital VAS across participants
Time frame: 0 weeks from date of consent
Anxiety Digital VAS Mean Score at 5 weeks
Average score on the 100 point digital VAS across participants
Time frame: 5 weeks from date of consent
Anxiety Digital VAS Mean Score at 10 weeks
Average score on the 100 point digital VAS across participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 weeks from date of consent
Sleep Condition Index (SCI) Mean Score at 0 weeks
Average score on the SCI across participants
Time frame: 0 weeks from date of consent
Sleep Condition Index (SCI) Mean Score at 5 weeks
Average score on the SCI across participants
Time frame: 5 weeks from date of consent
Sleep Condition Index (SCI) Mean Score at 10 weeks
Average score on the SCI across participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 10 weeks from date of consent
PAM-10 Mean Score at 0 weeks
Average score on the PAM-10 across participants
Time frame: 0 weeks from date of consent
PAM-10 Mean Score at 5 weeks
Average score on the PAM-10 across participants
Time frame: 5 weeks from date of consent
PAM-10 Mean Score at 10 weeks
Average score on the PAM-10 across participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 0 weeks from date of consent
App user retention
Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Northumbria University