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

Primary Purpose

Sjogren's Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-management app with all intervention components
Self-management app with Information component only
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sjogren's Syndrome focused on measuring Self-management, Smartphone, Autoimmune, Rheumatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full app with all app components

Control minimal app with information component only

Arm Description

Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.

Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.

Outcomes

Primary Outcome Measures

Number of people downloading the app
Total number of people who download the app from App Stores
Percentage of eligible users (denominator is number downloading)
Proportion of users who have downloaded the app that are eligible to participate
Percentage of consenting users (denominator is number eligible)
Proportion of those who are eligible to participate that consented to take part in the study
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.
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
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
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
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
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
ICECAP-A Mean Score at 0 weeks
Average score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Mean Score at 5 weeks
Average score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Mean Score at 10 weeks
Average score on "ICECAP-A" Quality of Life measure across participants
ICECAP-A Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
ICECAP-A Standard Deviation of Mean Score at 10 weeks
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
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).
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).
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).
ESSPRI Mean Score at 0 weeks
Average score on "ESSPRI" symptom severity measure across participants
ESSPRI Mean Score at 5 weeks
Average score on "ESSPRI" symptom severity measure across participants
ESSPRI Mean Score at 10 weeks
Average score on "ESSPRI" symptom severity measure across participants
ESSPRI Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
ESSPRI Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
ESSPRI Standard Deviation of Mean Score at 10 weeks
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
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
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
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
MFIS-5 Mean Score at 0 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
MFIS-5 Mean Score at 5 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
MFIS-5 Mean Score at 10 weeks
Average score on the MFIS-5 fatigue impact measure, across participants
MFIS-5 Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
MFIS-5 Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
MFIS-5 Standard Deviation of Mean Score at 10 weeks
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
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
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
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
Average score on the 100 point digital VAS across participants
Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks
Average score on the 100 point digital VAS across participants
Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks
Average score on the 100 point digital VAS across participants
Depression Digital VAS Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on depression VAS across participants
Depression Digital VAS Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on depression VAS across participants
Depression Digital VAS Standard Deviation of Mean Score at 10 weeks
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
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
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
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
Average score on the 100 point digital VAS across participants
Anxiety Digital VAS Mean Score at 5 weeks
Average score on the 100 point digital VAS across participants
Anxiety Digital VAS Mean Score at 10 weeks
Average score on the 100 point digital VAS across participants
Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks
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
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
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
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
Average score on the SCI across participants
Sleep Condition Index (SCI) Mean Score at 5 weeks
Average score on the SCI across participants
Sleep Condition Index (SCI) Mean Score at 10 weeks
Average score on the SCI across participants
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on the SCI across participants
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on the SCI across participants
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks
Standard deviation around Mean Score on the SCI across participants
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)
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)
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)
PAM-10 Mean Score at 0 weeks
Average score on the PAM-10 across participants
PAM-10 Mean Score at 5 weeks
Average score on the PAM-10 across participants
PAM-10 Mean Score at 10 weeks
Average score on the PAM-10 across participants
PAM-10 Standard Deviation of Mean Score at 0 weeks
Standard deviation around Mean Score on the PAM-10 across participants
PAM-10 Standard Deviation of Mean Score at 5 weeks
Standard deviation around Mean Score on the PAM-10 across participants
PAM-10 Standard Deviation of Mean Score at 10 weeks
Standard deviation around Mean Score on the PAM-10 across participants
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.

Secondary Outcome Measures

App user retention
Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs
Frequency of app engagement
The maximum, minimum and average number of times the app is launched
Duration of app engagement
The maximum, minimum and average length of time users interact with app
Depth of app engagement
The maximum, minimum and average number of times users interact with specific app features after launching the app
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.

Full Information

First Posted
November 24, 2020
Last Updated
April 14, 2021
Sponsor
Northumbria University
Collaborators
Newcastle University, Teesside University, Versus Arthritis
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1. Study Identification

Unique Protocol Identification Number
NCT04653935
Brief Title
Pilot Feasibility Study of a Sjögren's Syndrome Self-management App
Official Title
Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University
Collaborators
Newcastle University, Teesside University, Versus Arthritis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome
Keywords
Self-management, Smartphone, Autoimmune, Rheumatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
996 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full app with all app components
Arm Type
Experimental
Arm Description
Users receive app that contains all intervention components including: Symptom and Lifestyle information, Energy management, Goal Setting, Managing Difficult Times, Assertiveness and Communication Skills.
Arm Title
Control minimal app with information component only
Arm Type
Active Comparator
Arm Description
Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.
Intervention Type
Behavioral
Intervention Name(s)
Self-management app with all intervention components
Other Intervention Name(s)
Sjogo app
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-management app with Information component only
Other Intervention Name(s)
Sjogo app_information only
Intervention Description
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
Primary Outcome Measure Information:
Title
Number of people downloading the app
Description
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
Title
Percentage of eligible users (denominator is number downloading)
Description
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
Title
Percentage of consenting users (denominator is number eligible)
Description
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
Title
Percentage of randomised users (denominator is number eligible)
Description
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
Title
Percentage of retained users (denominator is number consenting) at 5 weeks
Description
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
Title
Percentage of retained users (denominator is number consenting) at 10 weeks
Description
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
Title
ICECAP-A Completion rate (denominator is number consenting) at 0 weeks
Description
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
Title
ICECAP-A Completion rate (denominator is number consenting) at 5 weeks
Description
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
Title
ICECAP-A Completion rate (denominator is number consenting) at 10 weeks
Description
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
Title
ICECAP-A Mean Score at 0 weeks
Description
Average score on "ICECAP-A" Quality of Life Measure across participants
Time Frame
0 weeks from date of consent
Title
ICECAP-A Mean Score at 5 weeks
Description
Average score on "ICECAP-A" Quality of Life Measure across participants
Time Frame
5 weeks from date of consent
Title
ICECAP-A Mean Score at 10 weeks
Description
Average score on "ICECAP-A" Quality of Life measure across participants
Time Frame
10 weeks from date of consent
Title
ICECAP-A Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
Time Frame
0 weeks from date of consent
Title
ICECAP-A Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
Time Frame
5 weeks from date of consent
Title
ICECAP-A Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants
Time Frame
10 weeks from date of consent
Title
ESSPRI Completion Rate (denominator is number consenting) at 0 weeks
Description
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
Title
ESSPRI Completion Rate (denominator is number consenting) at 5 weeks
Description
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
Title
ESSPRI Completion Rate (denominator is number consenting) at 10 weeks
Description
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
Title
ESSPRI Mean Score at 0 weeks
Description
Average score on "ESSPRI" symptom severity measure across participants
Time Frame
0 weeks from date of consent
Title
ESSPRI Mean Score at 5 weeks
Description
Average score on "ESSPRI" symptom severity measure across participants
Time Frame
5 weeks from date of consent
Title
ESSPRI Mean Score at 10 weeks
Description
Average score on "ESSPRI" symptom severity measure across participants
Time Frame
10 weeks from date of consent
Title
ESSPRI Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
Time Frame
0 weeks from date of consent
Title
ESSPRI Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
Time Frame
5 weeks from date of consent
Title
ESSPRI Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on ESSPRI symptom severity measure across participants
Time Frame
10 weeks from date of consent
Title
MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks
Description
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
Title
MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks
Description
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
Title
MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks
Description
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
Title
MFIS-5 Mean Score at 0 weeks
Description
Average score on the MFIS-5 fatigue impact measure, across participants
Time Frame
0 weeks from date of consent
Title
MFIS-5 Mean Score at 5 weeks
Description
Average score on the MFIS-5 fatigue impact measure, across participants
Time Frame
5 weeks from date of consent
Title
MFIS-5 Mean Score at 10 weeks
Description
Average score on the MFIS-5 fatigue impact measure, across participants
Time Frame
10 weeks from date of consent
Title
MFIS-5 Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
Time Frame
0 weeks from date of consent
Title
MFIS-5 Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
Time Frame
5 weeks from date of consent
Title
MFIS-5 Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants
Time Frame
10 weeks from date of consent
Title
Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks
Description
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
Title
Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks
Description
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
Title
Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks
Description
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
Title
Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks
Description
Average score on the 100 point digital VAS across participants
Time Frame
0 weeks from date of consent
Title
Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks
Description
Average score on the 100 point digital VAS across participants
Time Frame
5 weeks from date of consent
Title
Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks
Description
Average score on the 100 point digital VAS across participants
Time Frame
10 weeks from date of consent
Title
Depression Digital VAS Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on depression VAS across participants
Time Frame
0 weeks from date of consent
Title
Depression Digital VAS Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on depression VAS across participants
Time Frame
5 weeks from date of consent
Title
Depression Digital VAS Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on depression VAS across participants
Time Frame
10 weeks from date of consent
Title
Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks
Description
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
Title
Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks
Description
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
Title
Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks
Description
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
Title
Anxiety Digital VAS Mean Score at 0 weeks
Description
Average score on the 100 point digital VAS across participants
Time Frame
0 weeks from date of consent
Title
Anxiety Digital VAS Mean Score at 5 weeks
Description
Average score on the 100 point digital VAS across participants
Time Frame
5 weeks from date of consent
Title
Anxiety Digital VAS Mean Score at 10 weeks
Description
Average score on the 100 point digital VAS across participants
Time Frame
10 weeks from date of consent
Title
Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Time Frame
0 weeks from date of consent
Title
Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Time Frame
5 weeks from date of consent
Title
Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on the Anxiety digital VAS across participants
Time Frame
10 weeks from date of consent
Title
Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks
Description
Percentage of those who consent to take part that complete all 8 questions of the SCI
Time Frame
0 weeks from date of consent
Title
Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks
Description
Percentage of those who consent to take part that complete all 8 questions of the SCI
Time Frame
5 weeks from date of consent
Title
Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks
Description
Percentage of those who consent to take part that complete all 8 questions of the SCI
Time Frame
10 weeks from date of consent
Title
Sleep Condition Index (SCI) Mean Score at 0 weeks
Description
Average score on the SCI across participants
Time Frame
0 weeks from date of consent
Title
Sleep Condition Index (SCI) Mean Score at 5 weeks
Description
Average score on the SCI across participants
Time Frame
5 weeks from date of consent
Title
Sleep Condition Index (SCI) Mean Score at 10 weeks
Description
Average score on the SCI across participants
Time Frame
10 weeks from date of consent
Title
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on the SCI across participants
Time Frame
0 weeks from date of consent
Title
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on the SCI across participants
Time Frame
5 weeks from date of consent
Title
Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on the SCI across participants
Time Frame
10 weeks from date of consent
Title
PAM-10 Completion Rate (denominator is number consenting) at 0 weeks
Description
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
Title
PAM-10 Completion Rate (denominator is number consenting) at 5 weeks
Description
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
Title
PAM-10 Completion Rate (denominator is number consenting) at 10 weeks
Description
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
Title
PAM-10 Mean Score at 0 weeks
Description
Average score on the PAM-10 across participants
Time Frame
0 weeks from date of consent
Title
PAM-10 Mean Score at 5 weeks
Description
Average score on the PAM-10 across participants
Time Frame
5 weeks from date of consent
Title
PAM-10 Mean Score at 10 weeks
Description
Average score on the PAM-10 across participants
Time Frame
10 weeks from date of consent
Title
PAM-10 Standard Deviation of Mean Score at 0 weeks
Description
Standard deviation around Mean Score on the PAM-10 across participants
Time Frame
0 weeks from date of consent
Title
PAM-10 Standard Deviation of Mean Score at 5 weeks
Description
Standard deviation around Mean Score on the PAM-10 across participants
Time Frame
5 weeks from date of consent
Title
PAM-10 Standard Deviation of Mean Score at 10 weeks
Description
Standard deviation around Mean Score on the PAM-10 across participants
Time Frame
10 weeks from date of consent
Title
User Demographics
Description
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
Secondary Outcome Measure Information:
Title
App user retention
Description
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.
Title
Frequency of app engagement
Description
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.
Title
Duration of app engagement
Description
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.
Title
Depth of app engagement
Description
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.
Title
Acceptability of app and study procedures
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie L Hackett, PhD
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire H McCallum, PhD
Organizational Affiliation
Northumbria University
Official's Role
Study Chair
Facility Information:
Facility Name
Northumbria University
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7YR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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