Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 4:14 AM
Study NCT ID:
NCT03851094
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2019-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@resmed.com.au', 'phone': '800-424-0737', 'title': 'Clinical Research Team', 'organization': 'ResMed'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data was collected over 90 days for each participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Control group\n\nStandard of care procedures for new CPAP patients were followed.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Wellth app\n\nWellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean PAP Usage at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (Group A)', 'description': 'Standard of care procedures for a new CPAP patient were applied.'}, {'id': 'OG001', 'title': 'Wellth App (Group B)', 'description': 'Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.67', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '4.59', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Average nightly CPAP use for the 90 day time frame.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants are included.'}, {'type': 'SECONDARY', 'title': '% of Participants That Meet Medicare Compliance Standard', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (Group A)', 'description': 'Standard of care procedures for a new CPAP patient were applied.'}, {'id': 'OG001', 'title': 'Wellth App (Group B)', 'description': 'Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Medicare compliance standard is using the PAP therapy for at least 4 hours per day on at least 70% of the days in a consecutive 30-day period any time in the first 90 days of therapy. Those that meet this standard are counted in the results below and divided by all patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in ESS Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (Group A)', 'description': 'Standard of care procedures for new CPAP patients were followed.'}, {'id': 'OG001', 'title': 'Wellth App (Group B)', 'description': 'Wellth app\n\nWellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '-2.63', 'spread': '3.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Epworth Sleepiness Scale (ESS) will be administered at baseline and 90 days. The unit for this outcome is points. The total score can range from 0 to 24. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome. A higher score indicates worse symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient reported outcomes data. If participant did not answer both questionnaires, their data is missing from this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in FOSQ-10 Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (Group A)', 'description': 'Standard of care procedures for new CPAP patients were followed.'}, {'id': 'OG001', 'title': 'Wellth App (Group B)', 'description': 'Wellth app\n\nWellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '2.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be administered at baseline and 90 days. The unit for this outcome is points. The range of scores is 5 to 20. Higher scores indicate better functional status. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient reported outcomes data. Only participants that completed both questionnaires are reported here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care (Group A)', 'description': 'Standard of care procedures for new CPAP patients were followed.'}, {'id': 'FG001', 'title': 'Wellth App (Group B)', 'description': 'Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant lost device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant returned device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care (Group A)', 'description': 'Standard of care procedures for new CPAP patients were followed.'}, {'id': 'BG001', 'title': 'Wellth App (Group B)', 'description': 'Wellth app: The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '48.9', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data was not included in this analysis.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'More than One', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Perceived Disease Severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.48', 'spread': '0.99', 'groupId': 'BG000'}, {'value': '5.33', 'spread': '1.31', 'groupId': 'BG001'}, {'value': '5.43', 'spread': '1.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is units on a scale, from 1 to 7. A higher score would mean increased agreeance with higher perceived disease severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Claustrophobia', 'classes': [{'title': 'Swimming, wearing a nose plug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '2.0', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'BG002'}]}]}, {'title': 'Catch breath during vigorous exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.0', 'groupId': 'BG002'}]}]}, {'title': 'Bad cold, difficult to breathe through nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '1.1', 'groupId': 'BG002'}]}]}, {'title': 'Wearing a mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'BG002'}]}]}, {'title': 'Snorkeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '2.0', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '1.2', 'groupId': 'BG002'}]}]}, {'title': 'Working under car or sink', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '1.0', 'groupId': 'BG002'}]}]}, {'title': 'Wearing CPAP mask/being on therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is units on a scale between 1 and 5. A higher score would indicate more anxiety with claustrophobic situations.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Coping Skills', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '0.46', 'groupId': 'BG000'}, {'value': '3.29', 'spread': '0.51', 'groupId': 'BG001'}, {'value': '3.45', 'spread': '0.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is points. Score ranges from 1 to 5. A higher score will have more of an influence on the relationship between the primary outcome (mean PAP usage) and the intervention.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Health Literacy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "These scores will be used as moderators of the intervention's effectiveness. The unit for this outcome is units on a scale, ranging from 1 to 5. A lower score would mean increased health literacy.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Baseline Analysis Population is comprised of participants that completed the first questionnaire. Missing data has been excluded.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-24', 'size': 1253723, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-02T17:34', 'hasProtocol': True}, {'date': '2019-07-24', 'size': 264347, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-02T17:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will consist of an allocation ratio of 2:1 (control:treatment).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2019-02-19', 'resultsFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-20', 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean PAP Usage at 90 Days', 'timeFrame': '90 days', 'description': 'Average nightly CPAP use for the 90 day time frame.'}], 'secondaryOutcomes': [{'measure': '% of Participants That Meet Medicare Compliance Standard', 'timeFrame': '90 days', 'description': 'Medicare compliance standard is using the PAP therapy for at least 4 hours per day on at least 70% of the days in a consecutive 30-day period any time in the first 90 days of therapy. Those that meet this standard are counted in the results below and divided by all patients.'}, {'measure': 'Change in ESS Questionnaire Scores', 'timeFrame': '90 days', 'description': 'Epworth Sleepiness Scale (ESS) will be administered at baseline and 90 days. The unit for this outcome is points. The total score can range from 0 to 24. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome. A higher score indicates worse symptoms.'}, {'measure': 'Change in FOSQ-10 Questionnaire Scores', 'timeFrame': '90 days', 'description': 'Functional Outcomes of Sleep Questionnaire (FOSQ-10) will be administered at baseline and 90 days. The unit for this outcome is points. The range of scores is 5 to 20. Higher scores indicate better functional status. A larger change or change that decreases from baseline will represent a better outcome. A smaller change or change that increases from baseline will represent a worse outcome.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to PAP therapy.', 'detailedDescription': "This is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to therapy. Randomization will include an allocation ratio of 2:1 (control:treatment).\n\nParticipants will be recruited based on evidence that they are struggling to achieve adherence to therapy after the first 3 nights of usage. Two 'site to participant' contacts are required during this study. These contacts can either occur at the clinical site or remotely (e.g., by telephone). During the initial contact, their interest in the study and eligibility will be confirmed, then they will be consented, asked to complete the Baseline Questionnaire, and their demographic information will be collected on case report forms (CRFs).\n\nParticipants randomized to the intervention (Group B) will be provided with information and assistance in downloading Restful to their smartphone and registering with Wellth.\n\nAt the final contact (90 days), the participant will be asked to complete an End of Study Questionnaire and the investigative staff will collect PAP therapy data for the trial period and record it on CRFs. Participants in Group B will have access to the Restful app discontinued. This completes the participant's active participation in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants (≥ 18 years of age)\n* New diagnosis of OSA\n* Prescribed CPAP or APAP for treatment of OSA\n* Prescribed a ResMed flow generator compatible with AirView\n* Owns a smart phone and is willing to download an app on their phone\n* Willing and able to give informed consent\n* Can read and comprehend written and spoken English\n\nExclusion Criteria:\n\n* Have used PAP therapy in the past\n* Have been prescribed bi-level or adaptive servo-ventilation therapy\n* Are participating in another app-based research study\n* Cannot participate for the full duration of the study (at least 90 days)\n* Participants who have a medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this study, or constitutes an unacceptable risk to the participant for the duration of the study'}, 'identificationModule': {'nctId': 'NCT03851094', 'acronym': 'Project Dahlia', 'briefTitle': 'Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients', 'orgStudyIdInfo': {'id': 'SLP-18-08-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care (Group A)', 'description': 'Standard of care is dictated by the HME normal practices for new CPAP patients.'}, {'type': 'EXPERIMENTAL', 'label': 'Wellth App (Group B)', 'description': 'Intervention is use of the Wellth app during the initial compliance period.', 'interventionNames': ['Behavioral: Wellth app']}], 'interventions': [{'name': 'Wellth app', 'type': 'BEHAVIORAL', 'otherNames': ['Restful'], 'description': 'The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.', 'armGroupLabels': ['Wellth App (Group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sleep Data', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Gina Merchant, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ResMed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wellth Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}