Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03299556
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2017-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.alfieri@pharma.com', 'phone': '(475) 299-6085', 'title': 'Thomas Alfieri, PhD - Director, Medical Affairs Strategic Research', 'organization': 'Purdue Pharma L.P.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected up to 12 months for participants in the WHT group. Up to a 12-month retrospective review of AE data was performed for the patients in the MPP and MPM control groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.', 'otherNumAtRisk': 146, 'deathsNumAtRisk': 146, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 0, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numerical Pain Score (NPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.'}, {'id': 'OG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'id': 'OG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.48', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '6.48', 'spread': '1.70', 'groupId': 'OG002'}]}]}, {'title': '12-month follow-up', 'categories': [{'measurements': [{'value': '5.22', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '6.10', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '6.15', 'spread': '1.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.'}, {'id': 'OG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'id': 'OG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.07', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '15.19', 'spread': '6.34', 'groupId': 'OG001'}, {'value': '14.63', 'spread': '4.90', 'groupId': 'OG002'}]}]}, {'title': '12-month follow-up', 'categories': [{'measurements': [{'value': '11.78', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '12.89', 'spread': '6.25', 'groupId': 'OG001'}, {'value': '11.31', 'spread': '5.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Daily Morphine Equivalents (MEQs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.'}, {'id': 'OG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'id': 'OG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '51.38', 'spread': '44.84', 'groupId': 'OG000'}, {'value': '56.83', 'spread': '76.30', 'groupId': 'OG001'}, {'value': '43.42', 'spread': '68.62', 'groupId': 'OG002'}]}]}, {'title': '12-month follow-up', 'categories': [{'measurements': [{'value': '38.36', 'spread': '34.88', 'groupId': 'OG000'}, {'value': '54.46', 'spread': '66.51', 'groupId': 'OG001'}, {'value': '43.69', 'spread': '51.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'calculated from health records, average amount of daily pain medication \\[as measured by the daily milligrams of morphine equivalents (MME)\\].', 'unitOfMeasure': 'MME', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.'}, {'id': 'OG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'id': 'OG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.'}], 'classes': [{'title': 'ODI (Back) Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.67', 'spread': '13.54', 'groupId': 'OG000'}, {'value': '55.05', 'spread': '12.43', 'groupId': 'OG001'}, {'value': '51.20', 'spread': '11.78', 'groupId': 'OG002'}]}]}, {'title': 'ODI (Back) 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.46', 'spread': '14.38', 'groupId': 'OG000'}, {'value': '53.99', 'spread': '12.99', 'groupId': 'OG001'}, {'value': '46.28', 'spread': '16.74', 'groupId': 'OG002'}]}]}, {'title': 'ODI (Neck) Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.07', 'spread': '14.51', 'groupId': 'OG000'}, {'value': '59.23', 'spread': '13.96', 'groupId': 'OG001'}, {'value': '53.10', 'spread': '13.70', 'groupId': 'OG002'}]}]}, {'title': 'ODI (Neck) 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.03', 'spread': '14.50', 'groupId': 'OG000'}, {'value': '59.59', 'spread': '13.79', 'groupId': 'OG001'}, {'value': '51.40', 'spread': '17.27', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers analyzed differ because two different measures were used - the ODI Back was administered only to patients with back pain, the ODI Neck was administered only to patients with neck pain.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Activity Levels (WHT Group Only)', 'timeFrame': '12 months', 'description': 'number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep (WHT Group Only)', 'timeFrame': '12 months', 'description': 'quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.'}, {'id': 'FG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'id': 'FG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '412', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Wearable Health Tracker (WHT)', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.'}, {'id': 'BG001', 'title': 'Historic Control (MPP)', 'description': 'Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'id': 'BG002', 'title': 'Concurrent Control (MPM)', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '47.1', 'spread': '12.5', 'groupId': 'BG002'}, {'value': '49.0', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '284', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '397', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-12', 'size': 191432, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-17T16:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2017-09-27', 'resultsFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-17', 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Activity Levels (WHT Group Only)', 'timeFrame': '12 months', 'description': 'number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.'}, {'measure': 'Sleep (WHT Group Only)', 'timeFrame': '12 months', 'description': 'quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.'}], 'primaryOutcomes': [{'measure': 'Numerical Pain Score (NPS)', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).'}, {'measure': 'Mean Daily Morphine Equivalents (MEQs)', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'calculated from health records, average amount of daily pain medication \\[as measured by the daily milligrams of morphine equivalents (MME)\\].'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline, 12-month follow-up', 'description': 'self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearable Health Technology', 'iPhone', 'Apple Watch', 'Pain Medication'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://journals.lww.com/clinicalpain/Fulltext/2022/12000/Long_term_Use_of_Wearable_Health_Technology_by.1.aspx', 'label': 'Long-term Use of Wearable Health Technology by Chronic Pain Patients'}]}, 'descriptionModule': {'briefSummary': 'This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.', 'detailedDescription': 'This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT.\n\nThe WHT will consist of:\n\n* AppleWatch and iPhone\n* Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph)\n* Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training\n\nSubjects will use the WHT 20 hours per day, every day for a period of 12 months.\n\nSubjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.\n\nOutcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to the MPP\n* Completion of the 3-day MPP training\n* Ability to understand and complete the informed consent form prior to the initiation of any study procedures\n* Adequate motor skills needed to utilize WHT\n* Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process\n* Ability to understand spoken and written English\n\nExclusion Criteria:\n\n* Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease\n* Hospitalization \\>30 days during the 12 months prior to Index Date\n* Nursing home or hospice care during the 12 months prior to Index Date\n* Presence of an EHR Diagnosis description "OPT-OUT CENTER RESEARCH" which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research\n* Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence'}, 'identificationModule': {'nctId': 'NCT03299556', 'briefTitle': 'Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System', 'orgStudyIdInfo': {'id': '2017-0196'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'WHT', 'description': 'The WHT group includes only patients newly enrolled in the Geisinger MPP program who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.', 'interventionNames': ['Other: WHT']}, {'label': 'Historic Control', 'description': 'Patients who were enrolled in the MPP in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.'}, {'label': 'Concurrent Control', 'description': 'Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment'}], 'interventions': [{'name': 'WHT', 'type': 'OTHER', 'description': 'Incorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training.', 'armGroupLabels': ['WHT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health System', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Thomas Alfieri, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Purdue Pharma LP'}, {'name': 'John J Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue Pharma LP', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Geisinger Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}