Sjogren's Syndrome
Conditions
Keywords
Self-management, Smartphone, Autoimmune, Rheumatology
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).
Interventions
BEHAVIORALSelf-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.
BEHAVIORALSelf-management app with Information component only
self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
Sponsors
Newcastle University
Teesside University
Versus Arthritis
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User Demographics | 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. |
| PAM-10 Mean Score at 5 weeks | 5 weeks from date of consent | Average score on the PAM-10 across participants |
| PAM-10 Mean Score at 10 weeks | 10 weeks from date of consent | Average score on the PAM-10 across participants |
| PAM-10 Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on the PAM-10 across participants |
| PAM-10 Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on the PAM-10 across participants |
| PAM-10 Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on the PAM-10 across participants |
| Number of people downloading the app | Through to completion of data collection period of up to 6 months | Total number of people who download the app from App Stores |
| Percentage of eligible users (denominator is number downloading) | Through to completion of data collection period up to 6 months | Proportion of users who have downloaded the app that are eligible to participate |
| Percentage of consenting users (denominator is number eligible) | Through to completion of data collection period up to 6 months | Proportion of those who are eligible to participate that consented to take part in the study |
| Percentage of randomised users (denominator is number eligible) | Through to completion of data collection period up to 6 months | Proportion of those who are eligible to participate that complete all surveys at week 0 and then automatically randomised to one of two app versions. |
| Percentage of retained users (denominator is number consenting) at 5 weeks | Through to completion of data collection period up to 6 months | Proportion of those who those who consent to participate that complete all surveys at 5 weeks |
| Percentage of retained users (denominator is number consenting) at 10 weeks | Through to completion of data collection period up to 6 months | Proportion of those who those who consent to participate that complete all surveys at 10 weeks |
| ICECAP-A Completion rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey |
| ICECAP-A Completion rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey |
| ICECAP-A Completion rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey |
| ICECAP-A Mean Score at 0 weeks | 0 weeks from date of consent | Average score on ICECAP-A Quality of Life Measure across participants |
| ICECAP-A Mean Score at 5 weeks | 5 weeks from date of consent | Average score on ICECAP-A Quality of Life Measure across participants |
| ICECAP-A Mean Score at 10 weeks | 10 weeks from date of consent | Average score on ICECAP-A Quality of Life measure across participants |
| ICECAP-A Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on ICECAP-A Quality of Life Measure across participants |
| ICECAP-A Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on ICECAP-A Quality of Life Measure across participants |
| ICECAP-A Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on ICECAP-A Quality of Life Measure across participants |
| ESSPRI Completion Rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms). |
| ESSPRI Completion Rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete all 3 questions of ESSPRI survey (assessing dryness, fatigue and pain symptoms). |
| ESSPRI Completion Rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete all 3 questions of ESSPRI symptom severity survey (assessing dryness, fatigue and pain symptoms). |
| ESSPRI Mean Score at 0 weeks | 0 weeks from date of consent | Average score on ESSPRI symptom severity measure across participants |
| ESSPRI Mean Score at 5 weeks | 5 weeks from date of consent | Average score on ESSPRI symptom severity measure across participants |
| ESSPRI Mean Score at 10 weeks | 10 weeks from date of consent | Average score on ESSPRI symptom severity measure across participants |
| ESSPRI Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on ESSPRI symptom severity measure across participants |
| ESSPRI Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on ESSPRI symptom severity measure across participants |
| ESSPRI Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on ESSPRI symptom severity measure across participants |
| MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale |
| MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale |
| MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale |
| MFIS-5 Mean Score at 0 weeks | 0 weeks from date of consent | Average score on the MFIS-5 fatigue impact measure, across participants |
| MFIS-5 Mean Score at 5 weeks | 5 weeks from date of consent | Average score on the MFIS-5 fatigue impact measure, across participants |
| MFIS-5 Mean Score at 10 weeks | 10 weeks from date of consent | Average score on the MFIS-5 fatigue impact measure, across participants |
| MFIS-5 Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants |
| MFIS-5 Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants |
| MFIS-5 Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants |
| Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression |
| Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression |
| Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression |
| Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks | 0 weeks from date of consent | Average score on the 100 point digital VAS across participants |
| Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks | 5 weeks from date of consent | Average score on the 100 point digital VAS across participants |
| Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks | 10 weeks from date of consent | Average score on the 100 point digital VAS across participants |
| Depression Digital VAS Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on depression VAS across participants |
| Depression Digital VAS Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on depression VAS across participants |
| Depression Digital VAS Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on depression VAS across participants |
| Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety |
| Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety |
| Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety |
| Anxiety Digital VAS Mean Score at 0 weeks | 0 weeks from date of consent | Average score on the 100 point digital VAS across participants |
| Anxiety Digital VAS Mean Score at 5 weeks | 5 weeks from date of consent | Average score on the 100 point digital VAS across participants |
| Anxiety Digital VAS Mean Score at 10 weeks | 10 weeks from date of consent | Average score on the 100 point digital VAS across participants |
| Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on the Anxiety digital VAS across participants |
| Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on the Anxiety digital VAS across participants |
| Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on the Anxiety digital VAS across participants |
| Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete all 8 questions of the SCI |
| Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete all 8 questions of the SCI |
| Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete all 8 questions of the SCI |
| Sleep Condition Index (SCI) Mean Score at 0 weeks | 0 weeks from date of consent | Average score on the SCI across participants |
| Sleep Condition Index (SCI) Mean Score at 5 weeks | 5 weeks from date of consent | Average score on the SCI across participants |
| Sleep Condition Index (SCI) Mean Score at 10 weeks | 10 weeks from date of consent | Average score on the SCI across participants |
| Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks | 0 weeks from date of consent | Standard deviation around Mean Score on the SCI across participants |
| Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks | 5 weeks from date of consent | Standard deviation around Mean Score on the SCI across participants |
| Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks | 10 weeks from date of consent | Standard deviation around Mean Score on the SCI across participants |
| PAM-10 Completion Rate (denominator is number consenting) at 0 weeks | 0 weeks from date of consent | Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10) |
| PAM-10 Completion Rate (denominator is number consenting) at 5 weeks | 5 weeks from date of consent | Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10) |
| PAM-10 Completion Rate (denominator is number consenting) at 10 weeks | 10 weeks from date of consent | Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10) |
| PAM-10 Mean Score at 0 weeks | 0 weeks from date of consent | Average score on the PAM-10 across participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of app engagement | 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 |
| Duration of app engagement | 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 |
| Depth of app engagement | 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 |
| 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 | 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. |
| App user retention | 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 |
Countries
United Kingdom
Outcome results
None listed