Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04653935
Status:
UNKNOWN
Last Update Posted:
2021-04-15
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Feasibility Study of a Sjögren's Syndrome Self-management App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 996}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of people downloading the app', 'timeFrame': 'Through to completion of data collection period of up to 6 months', 'description': 'Total number of people who download the app from App Stores'}, {'measure': 'Percentage of eligible users (denominator is number downloading)', 'timeFrame': 'Through to completion of data collection period up to 6 months', 'description': 'Proportion of users who have downloaded the app that are eligible to participate'}, {'measure': 'Percentage of consenting users (denominator is number eligible)', 'timeFrame': 'Through to completion of data collection period up to 6 months', 'description': 'Proportion of those who are eligible to participate that consented to take part in the study'}, {'measure': 'Percentage of randomised users (denominator is number eligible)', 'timeFrame': 'Through to completion of data collection period up to 6 months', '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.'}, {'measure': 'Percentage of retained users (denominator is number consenting) at 5 weeks', 'timeFrame': 'Through to completion of data collection period up to 6 months', 'description': 'Proportion of those who those who consent to participate that complete all surveys at 5 weeks'}, {'measure': 'Percentage of retained users (denominator is number consenting) at 10 weeks', 'timeFrame': 'Through to completion of data collection period up to 6 months', 'description': 'Proportion of those who those who consent to participate that complete all surveys at 10 weeks'}, {'measure': 'ICECAP-A Completion rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey'}, {'measure': 'ICECAP-A Completion rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey'}, {'measure': 'ICECAP-A Completion rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 5 questions of ICECAP-A survey'}, {'measure': 'ICECAP-A Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on "ICECAP-A" Quality of Life Measure across participants'}, {'measure': 'ICECAP-A Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on "ICECAP-A" Quality of Life Measure across participants'}, {'measure': 'ICECAP-A Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on "ICECAP-A" Quality of Life measure across participants'}, {'measure': 'ICECAP-A Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants'}, {'measure': 'ICECAP-A Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants'}, {'measure': 'ICECAP-A Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on "ICECAP-A" Quality of Life Measure across participants'}, {'measure': 'ESSPRI Completion Rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', '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).'}, {'measure': 'ESSPRI Completion Rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 3 questions of ESSPRI survey (assessing dryness, fatigue and pain symptoms).'}, {'measure': 'ESSPRI Completion Rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', '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).'}, {'measure': 'ESSPRI Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on "ESSPRI" symptom severity measure across participants'}, {'measure': 'ESSPRI Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on "ESSPRI" symptom severity measure across participants'}, {'measure': 'ESSPRI Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on "ESSPRI" symptom severity measure across participants'}, {'measure': 'ESSPRI Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on ESSPRI symptom severity measure across participants'}, {'measure': 'ESSPRI Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on ESSPRI symptom severity measure across participants'}, {'measure': 'ESSPRI Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on ESSPRI symptom severity measure across participants'}, {'measure': 'MFIS-5 Completion Rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale'}, {'measure': 'MFIS-5 Completion Rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale'}, {'measure': 'MFIS-5 Completion Rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 5 questions of the Modified Fatigue Impact Scale'}, {'measure': 'MFIS-5 Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on the MFIS-5 fatigue impact measure, across participants'}, {'measure': 'MFIS-5 Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on the MFIS-5 fatigue impact measure, across participants'}, {'measure': 'MFIS-5 Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on the MFIS-5 fatigue impact measure, across participants'}, {'measure': 'MFIS-5 Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants'}, {'measure': 'MFIS-5 Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants'}, {'measure': 'MFIS-5 Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on MFIS-5 fatigue impact measure across participants'}, {'measure': 'Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression'}, {'measure': 'Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression'}, {'measure': 'Depression Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete the single digital VAS regarding severity of depression'}, {'measure': 'Depression Digital Visual Analogue Scale (VAS) Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on the 100 point digital VAS across participants'}, {'measure': 'Depression Digital Visual Analogue Scale (VAS) Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on the 100 point digital VAS across participants'}, {'measure': 'Depression Digital Visual Analogue Scale (VAS) Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on the 100 point digital VAS across participants'}, {'measure': 'Depression Digital VAS Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on depression VAS across participants'}, {'measure': 'Depression Digital VAS Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on depression VAS across participants'}, {'measure': 'Depression Digital VAS Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on depression VAS across participants'}, {'measure': 'Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety'}, {'measure': 'Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety'}, {'measure': 'Anxiety Digital Visual Analogue Scale (VAS) Completion Rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete the single digital VAS regarding severity of anxiety'}, {'measure': 'Anxiety Digital VAS Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on the 100 point digital VAS across participants'}, {'measure': 'Anxiety Digital VAS Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on the 100 point digital VAS across participants'}, {'measure': 'Anxiety Digital VAS Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on the 100 point digital VAS across participants'}, {'measure': 'Anxiety Digital VAS Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the Anxiety digital VAS across participants'}, {'measure': 'Anxiety Digital VAS Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the Anxiety digital VAS across participants'}, {'measure': 'Anxiety Digital VAS Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the Anxiety digital VAS across participants'}, {'measure': 'Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 8 questions of the SCI'}, {'measure': 'Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 8 questions of the SCI'}, {'measure': 'Sleep Condition Index (SCI) Completion Rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 8 questions of the SCI'}, {'measure': 'Sleep Condition Index (SCI) Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on the SCI across participants'}, {'measure': 'Sleep Condition Index (SCI) Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on the SCI across participants'}, {'measure': 'Sleep Condition Index (SCI) Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on the SCI across participants'}, {'measure': 'Sleep Condition Index (SCI) Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the SCI across participants'}, {'measure': 'Sleep Condition Index (SCI) Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the SCI across participants'}, {'measure': 'Sleep Condition Index (SCI) Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the SCI across participants'}, {'measure': 'PAM-10 Completion Rate (denominator is number consenting) at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)'}, {'measure': 'PAM-10 Completion Rate (denominator is number consenting) at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)'}, {'measure': 'PAM-10 Completion Rate (denominator is number consenting) at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Percentage of those who consent to take part that complete all 10 questions of the Patient Activation Measure (PAM-10)'}, {'measure': 'PAM-10 Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Average score on the PAM-10 across participants'}, {'measure': 'PAM-10 Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Average score on the PAM-10 across participants'}, {'measure': 'PAM-10 Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Average score on the PAM-10 across participants'}, {'measure': 'PAM-10 Standard Deviation of Mean Score at 0 weeks', 'timeFrame': '0 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the PAM-10 across participants'}, {'measure': 'PAM-10 Standard Deviation of Mean Score at 5 weeks', 'timeFrame': '5 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the PAM-10 across participants'}, {'measure': 'PAM-10 Standard Deviation of Mean Score at 10 weeks', 'timeFrame': '10 weeks from date of consent', 'description': 'Standard deviation around Mean Score on the PAM-10 across participants'}, {'measure': 'User Demographics', 'timeFrame': '0 weeks from date of consent', '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."}], 'secondaryOutcomes': [{'measure': 'App user retention', 'timeFrame': 'Interaction data will be collected continuously for up to 13 weeks for each participant.', 'description': 'Percentage of participants who launch the app at least once a week as recorded by automatically-generated logs'}, {'measure': 'Frequency of app engagement', 'timeFrame': 'Interaction data will be collected continuously for up to 13 weeks for each participant.', 'description': 'The maximum, minimum and average number of times the app is launched'}, {'measure': 'Duration of app engagement', 'timeFrame': 'Interaction data will be collected continuously for up to 13 weeks for each participant.', 'description': 'The maximum, minimum and average length of time users interact with app'}, {'measure': 'Depth of app engagement', 'timeFrame': 'Interaction data will be collected continuously for up to 13 weeks for each participant.', 'description': 'The maximum, minimum and average number of times users interact with specific app features after launching the app'}, {'measure': 'Acceptability of app and study procedures', 'timeFrame': 'Interviews will take place after users have had the app installed on their device for 10 weeks after date of consent', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-management', 'Smartphone', 'Autoimmune', 'Rheumatology'], 'conditions': ["Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': "This study investigates the feasibility of a fully remote effectiveness evaluation of a self-management smartphone application for those with Sjogren's syndrome.", 'detailedDescription': "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.\n\nThe 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:\n\n* 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.\n* Control Group: minimal version of the app containing only the Symptom and Lifestyle Information component.\n\nTo 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 18 years of age\n* Diagnosed with either Primary or Secondary Sjogren's syndrome (self-report)\n* Own an iPhone or Android smartphone\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT04653935', 'briefTitle': "Pilot Feasibility Study of a Sjögren's Syndrome Self-management App", 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': "Fully-remote Trial of a Self-management App for Those Living With Sjögren's Syndrome: Randomised Pilot and Feasibility Study", 'orgStudyIdInfo': {'id': '118742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full app with all app components', '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.', 'interventionNames': ['Behavioral: Self-management app with all intervention components']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control minimal app with information component only', 'description': 'Users receive app that contains only Symptom and Lifestyle information, and cannot see other intervention components.', 'interventionNames': ['Behavioral: Self-management app with Information component only']}], 'interventions': [{'name': 'Self-management app with all intervention components', 'type': 'BEHAVIORAL', 'otherNames': ['Sjogo app'], '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.", 'armGroupLabels': ['Full app with all app components']}, {'name': 'Self-management app with Information component only', 'type': 'BEHAVIORAL', 'otherNames': ['Sjogo app_information only'], 'description': "self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.", 'armGroupLabels': ['Control minimal app with information component only']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE7 7YR', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Katie L Hackett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}, {'name': 'Claire H McCallum, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Northumbria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Newcastle University', 'class': 'OTHER'}, {'name': 'Teesside University', 'class': 'OTHER'}, {'name': 'Versus Arthritis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}