Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-26 @ 2:10 PM
Study NCT ID:
NCT00386256
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2006-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home Telerehabilitation for Deconditioned Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Nancy.Harada@va.gov', 'phone': '310-268-3632', 'title': 'Nancy Harada, PhD', 'organization': 'VA Greater Los Angeles Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Intervention was developed on a male Veteran population, direct comparisons between groups were formed based on the participant's preference, exercise adherence was based on participants' self reports, small convenience sample."}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Health Buddy Outpatient', 'description': 'Received Health Buddy, recruited from outpatient setting', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Telephone Outpatient', 'description': 'Received telephone counseling, recruited from outpatient setting', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Health Buddy Inpatient', 'description': 'Received Health Buddy, recruited from inpatient setting', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Telephone Inpatient', 'description': 'Received telephone counseling, recruited from inpatient setting', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trips/Falls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exercise Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Buddy Outpatient', 'description': 'Received Health Buddy, recruited from outpatient setting'}, {'id': 'OG001', 'title': 'Telephone Outpatient', 'description': 'Received telephone counseling, recruited from outpatient setting'}, {'id': 'OG002', 'title': 'Health Buddy Inpatient', 'description': 'Received Health Buddy, recruited from inpatient setting'}, {'id': 'OG003', 'title': 'Telephone Inpatient', 'description': 'Received telephone counseling, recruited from inpatient setting'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '56.2', 'spread': '15.6', 'groupId': 'OG002'}, {'value': '35.1', 'spread': '20.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at monthly intervals, for 3-months', 'description': 'An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.', 'unitOfMeasure': 'percentage of days adhered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HB/Phone Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Buddy Outpatient', 'description': 'Received Health Buddy, recruited from outpatient setting'}, {'id': 'OG001', 'title': 'Telephone Outpatient', 'description': 'Received telephone counseling, recruited from outpatient setting'}, {'id': 'OG002', 'title': 'Health Buddy Inpatient', 'description': 'Received Health Buddy, recruited from inpatient setting'}, {'id': 'OG003', 'title': 'Telephone Inpatient', 'description': 'Received telephone counseling, recruited from inpatient setting'}], 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '24.2', 'groupId': 'OG001'}, {'value': '70.1', 'spread': '26.3', 'groupId': 'OG002'}, {'value': '43.7', 'spread': '25.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Monthly over 3 months', 'description': 'An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.', 'unitOfMeasure': 'percentage of days adhered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Health Buddy Outpatient', 'description': "Health Buddy(R), Home telehealth technology : Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety."}, {'id': 'FG001', 'title': 'Telephone Outpatient'}, {'id': 'FG002', 'title': 'Health Buddy Inpatient'}, {'id': 'FG003', 'title': 'Telephone Inpatient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from both the inpatient and outpatient settings of a large urban academic VA hospital. Potential participants were recruited through referrals from physicians, case managers, and social workers, participant recruitment fairs, and flyers posted around the hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Health Buddy Outpatient', 'description': 'Received Health Buddy, recruited from outpatient setting'}, {'id': 'BG001', 'title': 'Telephone Outpatient', 'description': 'Received telephone counseling, recruited from outpatient setting'}, {'id': 'BG002', 'title': 'Health Buddy Inpatient', 'description': 'Received Health Buddy, recruited from inpatient setting'}, {'id': 'BG003', 'title': 'Telephone Inpatient', 'description': 'Received telephone counseling, recruited from inpatient setting'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '65', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '78', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '76', 'spread': '7.5', 'groupId': 'BG003'}, {'value': '72.2', 'spread': '6.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2006-10-06', 'resultsFirstSubmitDate': '2013-09-11', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-12', 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Adherence', 'timeFrame': 'at monthly intervals, for 3-months', 'description': 'An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.'}, {'measure': 'HB/Phone Adherence', 'timeFrame': 'Monthly over 3 months', 'description': 'An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['telehealth', 'telerehabilitation', 'deconditioning', 'exercise'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '20803390', 'type': 'DERIVED', 'citation': 'Harada ND, Dhanani S, Elrod M, Hahn T, Kleinman L, Fang M. Feasibility study of home telerehabilitation for physically inactive veterans. J Rehabil Res Dev. 2010;47(5):465-75. doi: 10.1682/jrrd.2009.09.0149.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to develop a home exercise program for patients 60 years of age and over who are deconditioned following their discharge from the hospital, or recruited from GLA outpatient clinics. The program will be designed to monitor and improve patients' exercise behavior through the use of home technology, such as text messaging monitors.", 'detailedDescription': 'The aim of this study is to develop and determine the feasibility of implementing a home exercise and functional status monitoring telerehabilitation program, known as TEL-REHAB, for older adults 60 years of age and over who are deconditioned following their discharge from the inpatient setting, or recruited from GLA outpatient clinics. Deconditioning is a modifiable risk factor for preventing institutionalization of frail elderly patients who would otherwise be able to live independently. Home exercise programs are an effective intervention to reduce the risk, but patient compliance with home exercise programs, and assessments of patients during home exercise programs, are barriers to achieving maximal benefits. Face-to-face visits with physical medicine professionals are an effective means to perform these functions, but are problematic because of professional time impacts and patient transportation problems. A TEL-REHAB program will empower these patients to take responsibility for their own health by providing ongoing communication with a healthcare provider. In this way, telerehabilitation may assist older adults to remain independent in their homes as long as possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute decline in functional status while hospitalized as reported by the patient\n* physically inactive outpatients (exercise less than 30 min/day, 3 d/wk)\n* ability to hear and communicate via telephone\n* ability to read a video or text monitor\n* ability to manually operate the technology\n* have a working telephone and power source\n* willingness to use the TEL-REHAB technology\n\nExclusion Criteria:\n\n* does not speak English\n* poor cognition as determined by the Mini-Cog\n* non-ambulatory\n* had a stroke, myocardial infarction, hip fracture, or total hip or knee replacement within the prior 6 months'}, 'identificationModule': {'nctId': 'NCT00386256', 'briefTitle': 'Home Telerehabilitation for Deconditioned Older Adults', 'nctIdAliases': ['NCT00929149'], 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Home Based Telerehabilitation for Deconditioned Older Adults', 'orgStudyIdInfo': {'id': 'E4204-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health Buddy outpatient', 'description': 'Received home telehealth monitoring by Health Buddy', 'interventionNames': ['Device: Health Buddy, Home telehealth technology']}, {'type': 'EXPERIMENTAL', 'label': 'Telephone outpatient', 'interventionNames': ['Other: Telephone counseling']}, {'type': 'EXPERIMENTAL', 'label': 'health buddy inpatient', 'interventionNames': ['Device: Health Buddy, Home telehealth technology']}, {'type': 'EXPERIMENTAL', 'label': 'telephone inpatient', 'interventionNames': ['Other: Telephone counseling']}], 'interventions': [{'name': 'Health Buddy, Home telehealth technology', 'type': 'DEVICE', 'description': "Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.", 'armGroupLabels': ['Health Buddy outpatient', 'health buddy inpatient']}, {'name': 'Telephone counseling', 'type': 'OTHER', 'armGroupLabels': ['Telephone outpatient', 'telephone inpatient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, West LA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}], 'overallOfficials': [{'name': 'Nancy D. Harada, PhD MPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, West LA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}