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

Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04653935
• Other study ID #: 118742
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: July 2021

Study information

• Verified date: November 2020
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 996
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Behavioral:
• Self-management app with all intervention components
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 only
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle Upon Tyne	Tyne And Wear

Sponsors (4)

Lead Sponsor	Collaborator
Northumbria University	Newcastle University, Teesside University, Versus Arthritis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of people downloading the app	Total number of people who download the app from App Stores	Through to completion of data collection period of up to 6 months
Primary	Percentage of eligible users (denominator is number downloading)	Proportion of users who have downloaded the app that are eligible to participate	Through to completion of data collection period up to 6 months
Primary	Percentage of consenting users (denominator is number eligible)	Proportion of those who are eligible to participate that consented to take part in the study	Through to completion of data collection period up to 6 months
Primary	Percentage of randomised users (denominator is number eligible)	Proportion of those who are eligible to participate that complete all surveys at week 0 and then automatically randomised to one of two app versions.	Through to completion of data collection period up to 6 months
Primary	Percentage of retained users (denominator is number consenting) at 5 weeks	Proportion of those who those who consent to participate that complete all surveys at 5 weeks	Through to completion of data collection period up to 6 months
Primary	Percentage of retained users (denominator is number consenting) at 10 weeks	Proportion of those who those who consent to participate that complete all surveys at 10 weeks	Through to completion of data collection period up to 6 months
Primary	ICECAP-A Completion rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey	0 weeks from date of consent
Primary	ICECAP-A Completion rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey	5 weeks from date of consent
Primary	ICECAP-A Completion rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey	10 weeks from date of consent
Primary	ICECAP-A Mean Score at 0 weeks	Average score on "ICECAP-A" Quality of Life Measure across participants	0 weeks from date of consent
Primary	ICECAP-A Mean Score at 5 weeks	Average score on "ICECAP-A" Quality of Life Measure across participants	5 weeks from date of consent
Primary	ICECAP-A Mean Score at 10 weeks	Average score on "ICECAP-A" Quality of Life measure across participants	10 weeks from date of consent
Primary	ICECAP-A Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants	0 weeks from date of consent
Primary	ICECAP-A Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants	5 weeks from date of consent
Primary	ICECAP-A Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants	10 weeks from date of consent
Primary	ESSPRI Completion Rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms).	0 weeks from date of consent
Primary	ESSPRI Completion Rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete all 3 questions of ESSPRI survey (assessing dryness, fatigue and pain symptoms).	5 weeks from date of consent
Primary	ESSPRI Completion Rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms).	10 weeks from date of consent
Primary	ESSPRI Mean Score at 0 weeks	Average score on "ESSPRI" symptom severity measure across participants	0 weeks from date of consent
Primary	ESSPRI Mean Score at 5 weeks	Average score on "ESSPRI" symptom severity measure across participants	5 weeks from date of consent
Primary	ESSPRI Mean Score at 10 weeks	Average score on "ESSPRI" symptom severity measure across participants	10 weeks from date of consent
Primary	ESSPRI Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on ESSPRI symptom severity measure across participants	0 weeks from date of consent
Primary	ESSPRI Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on ESSPRI symptom severity measure across participants	5 weeks from date of consent
Primary	ESSPRI Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on ESSPRI symptom severity measure across participants	10 weeks from date of consent
Primary	MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale	0 weeks from date of consent
Primary	MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale	5 weeks from date of consent
Primary	MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale	10 weeks from date of consent
Primary	MFIS-5 Mean Score at 0 weeks	Average score on the MFIS-5 fatigue impact measure, across participants	0 weeks from date of consent
Primary	MFIS-5 Mean Score at 5 weeks	Average score on the MFIS-5 fatigue impact measure, across participants	5 weeks from date of consent
Primary	MFIS-5 Mean Score at 10 weeks	Average score on the MFIS-5 fatigue impact measure, across participants	10 weeks from date of consent
Primary	MFIS-5 Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants	0 weeks from date of consent
Primary	MFIS-5 Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants	5 weeks from date of consent
Primary	MFIS-5 Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants	10 weeks from date of consent
Primary	Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression	0 weeks from date of consent
Primary	Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression	5 weeks from date of consent
Primary	Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression	10 weeks from date of consent
Primary	Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks	Average score on the 100 point digital VAS across participants	0 weeks from date of consent
Primary	Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks	Average score on the 100 point digital VAS across participants	5 weeks from date of consent
Primary	Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks	Average score on the 100 point digital VAS across participants	10 weeks from date of consent
Primary	Depression Digital VAS Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on depression VAS across participants	0 weeks from date of consent
Primary	Depression Digital VAS Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on depression VAS across participants	5 weeks from date of consent
Primary	Depression Digital VAS Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on depression VAS across participants	10 weeks from date of consent
Primary	Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety	0 weeks from date of consent
Primary	Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety	5 weeks from date of consent
Primary	Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety	10 weeks from date of consent
Primary	Anxiety Digital VAS Mean Score at 0 weeks	Average score on the 100 point digital VAS across participants	0 weeks from date of consent
Primary	Anxiety Digital VAS Mean Score at 5 weeks	Average score on the 100 point digital VAS across participants	5 weeks from date of consent
Primary	Anxiety Digital VAS Mean Score at 10 weeks	Average score on the 100 point digital VAS across participants	10 weeks from date of consent
Primary	Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on the Anxiety digital VAS across participants	0 weeks from date of consent
Primary	Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on the Anxiety digital VAS across participants	5 weeks from date of consent
Primary	Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on the Anxiety digital VAS across participants	10 weeks from date of consent
Primary	Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete all 8 questions of the SCI	0 weeks from date of consent
Primary	Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete all 8 questions of the SCI	5 weeks from date of consent
Primary	Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete all 8 questions of the SCI	10 weeks from date of consent
Primary	Sleep Condition Index (SCI) Mean Score at 0 weeks	Average score on the SCI across participants	0 weeks from date of consent
Primary	Sleep Condition Index (SCI) Mean Score at 5 weeks	Average score on the SCI across participants	5 weeks from date of consent
Primary	Sleep Condition Index (SCI) Mean Score at 10 weeks	Average score on the SCI across participants	10 weeks from date of consent
Primary	Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on the SCI across participants	0 weeks from date of consent
Primary	Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on the SCI across participants	5 weeks from date of consent
Primary	Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on the SCI across participants	10 weeks from date of consent
Primary	PAM-10 Completion Rate (denominator is number consenting) at 0 weeks	Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)	0 weeks from date of consent
Primary	PAM-10 Completion Rate (denominator is number consenting) at 5 weeks	Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)	5 weeks from date of consent
Primary	PAM-10 Completion Rate (denominator is number consenting) at 10 weeks	Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)	10 weeks from date of consent
Primary	PAM-10 Mean Score at 0 weeks	Average score on the PAM-10 across participants	0 weeks from date of consent
Primary	PAM-10 Mean Score at 5 weeks	Average score on the PAM-10 across participants	5 weeks from date of consent
Primary	PAM-10 Mean Score at 10 weeks	Average score on the PAM-10 across participants	10 weeks from date of consent
Primary	PAM-10 Standard Deviation of Mean Score at 0 weeks	Standard deviation around Mean Score on the PAM-10 across participants	0 weeks from date of consent
Primary	PAM-10 Standard Deviation of Mean Score at 5 weeks	Standard deviation around Mean Score on the PAM-10 across participants	5 weeks from date of consent
Primary	PAM-10 Standard Deviation of Mean Score at 10 weeks	Standard deviation around Mean Score on the PAM-10 across participants	10 weeks from date of consent
Primary	User Demographics	Investigator-developed questionnaire asking users to enter their gender (M/F/Other/Prefer not to say), age (years), whether users have primary or secondary Sjogren's syndrome, number of years since diagnosis, country of residence, and any other conditions users wish to report.	0 weeks from date of consent
Secondary	App user retention	Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs	Interaction data will be collected continuously for up to 13 weeks for each participant.
Secondary	Frequency of app engagement	The maximum, minimum and average number of times the app is launched	Interaction data will be collected continuously for up to 13 weeks for each participant.
Secondary	Duration of app engagement	The maximum, minimum and average length of time users interact with app	Interaction data will be collected continuously for up to 13 weeks for each participant.
Secondary	Depth of app engagement	The maximum, minimum and average number of times users interact with specific app features after launching the app	Interaction data will be collected continuously for up to 13 weeks for each participant.
Secondary	Acceptability of app and study procedures	All users will be invited to participate in a remote qualitative interview (up to 60 minutes). We do not expect that all participants will take part, and aim to recruit n=20 (10 in experimental group, 10 in control group). Interested users will be contacted via email to consent and arrange a suitable interview time. Semi-structured interviews will explore acceptability of the app and study procedures (i.e. affective attitude, burden, perceived effectiveness of the app, ethicality, app coherence, and opportunity costs) and usability of the app (informed by items on the System Usability Scale.	Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent