Sjogren's SyndromeNCT04653935
Pilot Feasibility Study of a Sjögren's Syndrome Self-management App
A study testing Self-management app with all intervention components and Self-management app with Information component only in people with Sjogren's Syndrome, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This study investigates the feasibility of a fully remote effectiveness evaluation of a self-management smartphone application for those with Sjogren's syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Self-management app with all intervention components and Self-management app with Information component only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 996 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)
- Own an iPhone or Android smartphone
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE7 7YR
About this study
Official title: 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.
Read the 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).
- Conditions
- Sjogren's Syndrome
- Being tested
- Self-management app with all intervention components, Self-management app with Information component only
- Keywords
- Self-management, Smartphone, Autoimmune, Rheumatology
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management app with all intervention componentsBehavioural
Also called Sjogo app
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 with Information component onlyBehavioural
Also called Sjogo app_information only
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
| Study group | Role | What they receive |
|---|---|---|
| Full app with all app components | Experimental | Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills. Receives: Behavioral: Self-management app with all intervention components |
| Control minimal app with information component only | Active comparator | Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components. Receives: Behavioral: Self-management app with Information component only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people downloading the app
Total number of people who download the app from App Stores
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 weeks from date of consent
ICECAP-A Mean Score at 0 weeks
Average score on "ICECAP-A" Quality of Life Measure across participants
Measured: 0 weeks from date of consent
ICECAP-A Mean Score at 5 weeks
Average score on "ICECAP-A" Quality of Life Measure across participants
Measured: 5 weeks from date of consent
ICECAP-A Mean Score at 10 weeks
Average score on "ICECAP-A" Quality of Life measure across participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 10 weeks from date of consent
ESSPRI Mean Score at 0 weeks
Average score on "ESSPRI" symptom severity measure across participants
Measured: 0 weeks from date of consent
ESSPRI Mean Score at 5 weeks
Average score on "ESSPRI" symptom severity measure across participants
Measured: 5 weeks from date of consent
ESSPRI Mean Score at 10 weeks
Average score on "ESSPRI" symptom severity measure across participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 weeks from date of consent
MFIS-5 Mean Score at 0 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
Measured: 0 weeks from date of consent
MFIS-5 Mean Score at 5 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
Measured: 5 weeks from date of consent
MFIS-5 Mean Score at 10 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 weeks from date of consent
Anxiety Digital VAS Mean Score at 0 weeks
Average score on the 100 point digital VAS across participants
Measured: 0 weeks from date of consent
Anxiety Digital VAS Mean Score at 5 weeks
Average score on the 100 point digital VAS across participants
Measured: 5 weeks from date of consent
Anxiety Digital VAS Mean Score at 10 weeks
Average score on the 100 point digital VAS across participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 weeks from date of consent
Sleep Condition Index (SCI) Mean Score at 0 weeks
Average score on the SCI across participants
Measured: 0 weeks from date of consent
Sleep Condition Index (SCI) Mean Score at 5 weeks
Average score on the SCI across participants
Measured: 5 weeks from date of consent
Sleep Condition Index (SCI) Mean Score at 10 weeks
Average score on the SCI across participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 10 weeks from date of consent
PAM-10 Mean Score at 0 weeks
Average score on the PAM-10 across participants
Measured: 0 weeks from date of consent
PAM-10 Mean Score at 5 weeks
Average score on the PAM-10 across participants
Measured: 5 weeks from date of consent
PAM-10 Mean Score at 10 weeks
Average score on the PAM-10 across participants
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 0 weeks from date of consent
Secondary outcomes (5)
App user retention
Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start6 Jan 2020
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 996 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Teesside University, Versus Arthritis
- Responsible party
- Sponsor
- Investigators
- Katie L Hackett, PhD, Principal investigator, Northumbria UniversityClaire H McCallum, PhD, Study chair, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653935
- Sponsor's protocol ID
- 118742
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT04653935
- Acronym / sponsor ID
- 118742
- Conditions
- Sjogren's Syndrome
- Keywords
- Self-management, Smartphone, Autoimmune, Rheumatology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 996 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Newcastle University, Teesside University, Versus Arthritis
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full app with all app components | Experimental | Behavioral: Self-management app with all intervention componentsUsers receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills. |
| Control minimal app with information component only | Active comparator | Behavioral: Self-management app with Information component onlyUsers receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)
- Own an iPhone or Android smartphone
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management app with all intervention componentsAlso: Sjogo appA 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. | Behavioural | Full app with all app components |
| Self-management app with Information component onlyAlso: Sjogo app_information onlyself-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only. | Behavioural | Control minimal app with information component only |
Primary outcome
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 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
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
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 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
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 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
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
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 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 Mean Score at 10 weeks
Time frame: 10 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 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
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 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
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
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 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
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 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
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
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
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 5 weeks
Time frame: 5 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 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) 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
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 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
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
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
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 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 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
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 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 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 0 weeks
Time frame: 0 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 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) 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
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) 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) Mean Score at 5 weeks
Time frame: 5 weeks from date of consent
Average score on the SCI across participants
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 0 weeks
Time frame: 0 weeks from date of consent
Standard deviation around Mean 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
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 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)
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 5 weeks
Time frame: 5 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
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 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
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.
5 secondary outcomes
App user retention
Time frame: Interaction data will be collected continuously for up to 13 weeks for each participant.
Frequency of app engagement
Time frame: Interaction data will be collected continuously for up to 13 weeks for each participant.
Duration of app engagement
Time frame: Interaction data will be collected continuously for up to 13 weeks for each participant.
Depth of app engagement
Time frame: Interaction data will be collected continuously for up to 13 weeks for each participant.
Acceptability of app and study procedures
Time frame: Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie L Hackett, PhD principal investigator
Northumbria University
Claire H McCallum, PhD study chair
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management app with all intervention components and Self-management app with Information component only in people with Sjogren's Syndrome, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people downloading the app (time frame: Through to completion of data collection period of up to 6 months). The study lists 70 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.