NCT04653935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
996

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 15, 2021

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

November 24, 2020

Last Update Submit

April 14, 2021

Conditions

Sjogren's Syndrome

Keywords

Self-managementSmartphoneAutoimmuneRheumatology

Outcome Measures

Primary Outcomes (70)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • ICECAP-A Mean Score at 0 weeks

    Average score on "ICECAP-A" Quality of Life Measure across participants

    0 weeks from date of consent

  • ICECAP-A Mean Score at 5 weeks

    Average score on "ICECAP-A" Quality of Life Measure across participants

    5 weeks from date of consent

  • ICECAP-A Mean Score at 10 weeks

    Average score on "ICECAP-A" Quality of Life measure across participants

    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

    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

    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

    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).

    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).

    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).

    10 weeks from date of consent

  • ESSPRI Mean Score at 0 weeks

    Average score on "ESSPRI" symptom severity measure across participants

    0 weeks from date of consent

  • ESSPRI Mean Score at 5 weeks

    Average score on "ESSPRI" symptom severity measure across participants

    5 weeks from date of consent

  • ESSPRI Mean Score at 10 weeks

    Average score on "ESSPRI" symptom severity measure across participants

    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

    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

    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

    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

    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

    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

    10 weeks from date of consent

  • MFIS-5 Mean Score at 0 weeks

    Average score on the MFIS-5 fatigue impact measure, across participants

    0 weeks from date of consent

  • MFIS-5 Mean Score at 5 weeks

    Average score on the MFIS-5 fatigue impact measure, across participants

    5 weeks from date of consent

  • MFIS-5 Mean Score at 10 weeks

    Average score on the MFIS-5 fatigue impact measure, across participants

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    10 weeks from date of consent

  • Anxiety Digital VAS Mean Score at 0 weeks

    Average score on the 100 point digital VAS across participants

    0 weeks from date of consent

  • Anxiety Digital VAS Mean Score at 5 weeks

    Average score on the 100 point digital VAS across participants

    5 weeks from date of consent

  • Anxiety Digital VAS Mean Score at 10 weeks

    Average score on the 100 point digital VAS across participants

    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

    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

    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

    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

    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

    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

    10 weeks from date of consent

  • Sleep Condition Index (SCI) Mean Score at 0 weeks

    Average score on the SCI across participants

    0 weeks from date of consent

  • Sleep Condition Index (SCI) Mean Score at 5 weeks

    Average score on the SCI across participants

    5 weeks from date of consent

  • Sleep Condition Index (SCI) Mean Score at 10 weeks

    Average score on the SCI across participants

    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

    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

    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

    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)

    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)

    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)

    10 weeks from date of consent

  • PAM-10 Mean Score at 0 weeks

    Average score on the PAM-10 across participants

    0 weeks from date of consent

  • PAM-10 Mean Score at 5 weeks

    Average score on the PAM-10 across participants

    5 weeks from date of consent

  • PAM-10 Mean Score at 10 weeks

    Average score on the PAM-10 across participants

    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

    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

    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

    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.

    0 weeks from date of consent

Secondary Outcomes (5)

  • App user retention

    Interaction data will be collected continuously for up to 13 weeks for each participant.

  • Frequency of app engagement

    Interaction data will be collected continuously for up to 13 weeks for each participant.

  • Duration of app engagement

    Interaction data will be collected continuously for up to 13 weeks for each participant.

  • Depth of app engagement

    Interaction data will be collected continuously for up to 13 weeks for each participant.

  • Acceptability of app and study procedures

    Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent

Study Arms (2)

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.

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.

Behavioral: Self-management app with Information component only

Interventions

Self-management app with all intervention componentsBEHAVIORAL

A behavioural self-management app, containing multiple cognitive- and behavioural self-management techniques for those living with Sjögren's syndrome. The intervention is comprised of several components and modules that holistically target several key symptoms: fatigue, sleep disturbances, chronic pain, and dryness. The app has been developed using user-centred methods, and is theory- and evidence-based.

Also known as: Sjogo app
Full app with all app components
Self-management app with Information component onlyBEHAVIORAL

self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.

Also known as: Sjogo app_information only
Control minimal app with information component only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE7 7YR, United Kingdom

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Katie L Hackett, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

  • Claire H McCallum, PhD

    Northumbria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 4, 2020

Study Start

January 6, 2020

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

April 15, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)