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

• ClinicalTrials.gov Identifier: NCT04653935
• Recruitment Status: Active, not recruiting
• First Posted: December 4, 2020
• Last Update Posted: April 15, 2021
• Sponsor: Northumbria University
• Collaborators: Newcastle University; Teesside University; Versus Arthritis
• Information provided by (Responsible Party): Northumbria University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sjogren's Syndrome	Behavioral: Self-management app with all intervention components; Behavioral: Self-management app with Information component only	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 996 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study
• Actual Study Start Date: January 6, 2020
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: July 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: Sjogo app
Active Comparator: Control minimal app with information component only; Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.	Behavioral: Self-management app with Information component only; self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.; Other Name: Sjogo app_information only

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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.
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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).
17. 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).
18. 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).
19. ESSPRI Mean Score at 0 weeks [ Time Frame: 0 weeks from date of consent ]
    Average score on "ESSPRI" symptom severity measure across participants
20. ESSPRI Mean Score at 5 weeks [ Time Frame: 5 weeks from date of consent ]
    Average score on "ESSPRI" symptom severity measure across participants
21. ESSPRI Mean Score at 10 weeks [ Time Frame: 10 weeks from date of consent ]
    Average score on "ESSPRI" symptom severity measure across participants
22. 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
23. 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
24. 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
25. 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
26. 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
27. 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
28. 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
29. 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
30. 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
31. 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
32. 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
33. 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
34. 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
35. 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
36. 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
37. 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
38. 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
39. 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
40. 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
41. 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
42. 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
43. 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
44. 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
45. 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
46. 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
47. 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
48. 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
49. 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
50. 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
51. 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
52. 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
53. 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
54. 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
55. Sleep Condition Index (SCI) Mean Score at 0 weeks [ Time Frame: 0 weeks from date of consent ]
    Average score on the SCI across participants
56. Sleep Condition Index (SCI) Mean Score at 5 weeks [ Time Frame: 5 weeks from date of consent ]
    Average score on the SCI across participants
57. Sleep Condition Index (SCI) Mean Score at 10 weeks [ Time Frame: 10 weeks from date of consent ]
    Average score on the SCI across participants
58. 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
59. 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
60. 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
61. 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)
62. 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)
63. 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)
64. PAM-10 Mean Score at 0 weeks [ Time Frame: 0 weeks from date of consent ]
    Average score on the PAM-10 across participants
65. PAM-10 Mean Score at 5 weeks [ Time Frame: 5 weeks from date of consent ]
    Average score on the PAM-10 across participants
66. PAM-10 Mean Score at 10 weeks [ Time Frame: 10 weeks from date of consent ]
    Average score on the PAM-10 across participants
67. 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
68. 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
69. 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
70. 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 Outcome Measures :

1. App user retention [ Time Frame: Interaction data will be collected continuously for up to 13 weeks for each participant. ]
   Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs
2. Frequency of app engagement [ Time Frame: Interaction data will be collected continuously for up to 13 weeks for each participant. ]
   The maximum, minimum and average number of times the app is launched
3. Duration of app engagement [ Time Frame: Interaction data will be collected continuously for up to 13 weeks for each participant. ]
   The maximum, minimum and average length of time users interact with app
4. Depth of app engagement [ Time Frame: Interaction data will be collected continuously for up to 13 weeks for each participant. ]
   The maximum, minimum and average number of times users interact with specific app features after launching the app
5. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Over 18 years of age
• Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)
• Own an iPhone or Android smartphone

Exclusion Criteria:

• None

Contacts and Locations

Locations

United Kingdom

Northumbria University

Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7YR

Sponsors and Collaborators

Northumbria University

Newcastle University

Teesside University

Versus Arthritis

Investigators

• Principal Investigator: Katie L Hackett, PhD; Northumbria University
• Study Chair: Claire H McCallum, PhD; Northumbria University

More Information

• Responsible Party: Northumbria University
• ClinicalTrials.gov Identifier: NCT04653935
• Other Study ID Numbers: 118742
• First Posted: December 4, 2020
• Last Update Posted: April 15, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Northumbria University:

Self-management; Smartphone; Autoimmune; Rheumatology

Additional relevant MeSH terms:

Sjogren's Syndrome; Syndrome; Disease; Pathologic Processes; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases