Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-03-01 @ 12:20 AM
Study NCT ID:
NCT02057068
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2014-01-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Sleep in Veterans and Their CGs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pcgriff@emory.edu', 'phone': '6783615462', 'title': 'Patricia C. Griffiths, PhD', 'organization': 'Atlanta Department of Veterans Affairs Medical Center CVNR'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a pilot and feasibility study involving dyads who self-selected into the program. The sample size is small, thus the results should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'Data were collected throughout the study. There were no adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Intervention\n\nAdaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching.\n\nThere were no adverse events.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait List Control Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. There were no adverse events.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Intervention\n\nAdaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching.'}, {'id': 'OG001', 'title': 'Wait List Control Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.41', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '8.31', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Post Intervention', 'categories': [{'measurements': [{'value': '5.98', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '4.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Intention to treat analysis with last observation carried forward', 'otherAnalysisDescription': 'Partial Eta Squared = .282'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) and Post-Intervention (T2) - 8 Weeks', 'description': 'Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score \\> 5 (some evidence for 8) is indicative of poor sleep quality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Six-Week Tele-Health Intervention\n\n1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.\n2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.\n3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).\n4. . SLEEP-E Dyads book\n5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching\n\nSLEEP-E Dyads Intervention: Described in arm/group description'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '82.19', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '82.55', 'spread': '5.71', 'groupId': 'OG001'}]}]}, {'title': 'Post Intervention', 'categories': [{'measurements': [{'value': '81.64', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '82.09', 'spread': '6.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Intention to treat analysis with last observation carried forward'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) and Post-Intervention (T2) - 8 Weeks', 'description': 'Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep.', 'unitOfMeasure': 'percentage of sleep/time in bed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BEF-SHI Total Number of Negative Sleep Hygiene Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Six-Week Tele-Health Intervention\n\n1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.\n2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.\n3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).\n4. . SLEEP-E Dyads book\n5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching\n\nSLEEP-E Dyads Intervention: Described in arm/group description'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.27', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Post Intervention', 'categories': [{'measurements': [{'value': '3.12', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (T1) and Post-Intervention (T2) - 8 Weeks', 'description': 'Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Intervention\n\nAdaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching.'}, {'id': 'FG001', 'title': 'Wait List Control Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '12 beta test dyads included in the intervention group, thus they were not randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Caregiver (CG) Health', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Carepartner (CP) Health', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment for the intervention occurred between 2014 and 2016. Participants were recruited from the Geriatrics Clinic, the CVNR Caregiver Registry and by referrals from Social Workers and Primary Care.', 'preAssignmentDetails': 'Participants were excluded from the study if both members of the dyad reported sleeping well (no sleep problems, high sleep quality) during baseline interview and/or had sleep efficiency of 85% or greater as measured by actigraphy during baseline week. Randomization occurred following baseline. Consented=102; Randomization=96.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Six-Week Tele-Health Intervention\n\n1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.\n2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.\n3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).\n4. . SLEEP-E Dyads book\n5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching\n\nSLEEP-E Dyads Intervention: Described in arm/group description'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.12', 'spread': '8.14', 'groupId': 'BG000'}, {'value': '70.11', 'spread': '9.43', 'groupId': 'BG001'}, {'value': '70.12', 'spread': '8.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures were collected in the home of the dyads by trained interviewers.\n\nIn addition dyads completed morning and evening daily diaries for 7 days.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This was dyadic data involving a Veteran and a co-habitating caregiver or a Veteran caregiver and his/her care-partner'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Dyads completed a comprehensive interview followed by a weeklong in-home sleep assessment (actigraphy) and journals. Dyads who didn't complete the week were excluded. Others reported sleeping well and were excluded based on that and/or actigraphic assessments. Dyads were randomized after baseline. Only completers were enrolled."}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This efficacy study was not blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Randomization to an immediate intervention group or a no-contact wait list control group. Following post intervention assessments the wait-list control group received the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2014-01-24', 'resultsFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-13', 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Sleep Quality', 'timeFrame': 'Baseline (T1) and Post-Intervention (T2) - 8 Weeks', 'description': 'Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score \\> 5 (some evidence for 8) is indicative of poor sleep quality.'}], 'secondaryOutcomes': [{'measure': 'Mean Sleep Efficiency', 'timeFrame': 'Baseline (T1) and Post-Intervention (T2) - 8 Weeks', 'description': 'Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep.'}, {'measure': 'BEF-SHI Total Number of Negative Sleep Hygiene Behaviors', 'timeFrame': 'Baseline (T1) and Post-Intervention (T2) - 8 Weeks', 'description': 'Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Caregivers', 'Telemedicine', 'Sleep Disorders', 'Meditation', 'Cognitive Behavioral Therapy', 'Activity Enhancement', 'Technology', 'Non-pharmacological sleep intervention'], 'conditions': ['Sleep Quality']}, 'descriptionModule': {'briefSummary': 'This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at home and being cared for by a family caregiver (CG). The purpose of the study was to develop and field test non-pharmacological, technology enhanced sleep hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving dyads.The conceptual framework of the intervention incorporated components of cognitive behavioral therapy, psycho-education and self-management support for individuals with chronic conditions with an emphasis on cultivating competence and mastery.', 'detailedDescription': 'Research Plan:\n\nSample. Veteran care receivers(CR s) or carepartners (CP) over the age of 60 who require assistance from a spousal or cohabitating caregiver (CG) and Veteran caregivers providing care for a cohabitating carepartner were recruited. Dyads underwent comprehensive baseline assessments consisting of in-person home-based interviews and iPad training (T1) followed by a week-long data collection of contemporaneous actigraphic sleep parameters and twice daily (morning and evening) indices of subjective sleep, activity, mood, behavior and sleep hygiene completed on the Tonic for Health Platform. Dyads were randomly assigned to an immediate intervention or wait-list control group. The immediate group received the intervention described below followed by post-intervention assessments (T2) identical to baseline. Wait-list participants then received the intervention followed by a final post-intervention assessment for the wait-list group only (T3).\n\nIntervention.\n\nDaily Videos: Video modules were delivered daily to the dyads\' iPads during the 6-week intervention. All participants received core programming of sleep hygiene education, and guided instruction for daily physical activity enhancement "Move-Out!" and meditation/relaxation/self-care "Stand Down!" sessions individualized to functional ability levels. The baseline data allowed for subsequent compilation and programming of individualized, algorithmically derived, adaptive prescriptions for relevant video modules, sleep hygiene recommendations and cognitive behavioral strategies based upon the three independent streams of objective and subjective data for each dyad member. During the intervention dyads completed brief morning and evening diaries to assess compliance with the intervention and capture daily mood and sleep/sleep hygiene data.\n\nTele-Video-Conferences: Each dyad participated in two tele-video conferences with the PI. The first was to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call was a check-in, encouragement, reinforcement and coaching call. Dyads were re-assessed following the 6-week intervention.\n\nEvaluations:\n\nStandardized quantitative evaluations regarding the utility of the program were completed following the post-intervention assessments on the iPads. A sub-sample of dyads also participated in qualitative interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,\n* have a life expectancy of greater than or equal to six (6) months,\n* have no plans for transitioning out of home in the next six months,\n* and have approval from the primary care provider to participate in the research.\n* Caregivers must live with care recipient\n* Caregivers must obtain a negative mini-cog assessment or negative TICS-m assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the care recipient so long as the two are cohabitating.\n* Caregiver can be any age.\n* For Phase 2 and Phase 3 of the study, either the care recipient or the caregiver must have difficulty sleeping as indicated by scores on the Insomnia Severity Index.\n\nExclusion Criteria:\n\n* Parkinson's with tremor or other movement disorder that would invalidate actigraphy\n* Untreated diagnosis of sleep apnea or restless leg syndrome\n* Inability to tolerate actigraphy\n* CG and CR sleep efficiency \\> 85% and/or both members of dyad report sleeping well\n* Caregivers must have a negative screen with the Mini-Cog or the ModifiedTelephone Interview for Cognitive Status (TICS-M) to demonstrate cognitive capacity to provide informed consent"}, 'identificationModule': {'nctId': 'NCT02057068', 'acronym': 'SLEEP-E Dyads', 'briefTitle': 'Improving Sleep in Veterans and Their CGs', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Sleep In Veterans and Their Family Caregivers', 'orgStudyIdInfo': {'id': 'E7249-W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLEEP-E Dyads Intervention', 'description': 'SLEEP-E Dyads Six-Week Tele-Health Intervention\n\n1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.\n2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.\n3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).\n4. . SLEEP-E Dyads book\n5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching', 'interventionNames': ['Behavioral: SLEEP-E Dyads Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group', 'description': 'During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.'}], 'interventions': [{'name': 'SLEEP-E Dyads Intervention', 'type': 'BEHAVIORAL', 'description': 'Described in arm/group description', 'armGroupLabels': ['SLEEP-E Dyads Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur, GA', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}], 'overallOfficials': [{'name': 'Patricia C Griffiths, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta VA Medical and Rehab Center, Decatur, GA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Emory University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}