Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-08 @ 12:40 AM
Study NCT ID:
NCT04423666
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2020-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were randomly assigned through a toss of a coin to either the intervention or control'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Convenience sample, randomized, intervention, pre-post design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '8 weeks', 'description': 'systolic/diastolic'}, {'measure': 'Pulse rate will be combined to report BMI in kg/m^2BMI', 'timeFrame': '8 weeks', 'description': 'count of pulse rate for one minute'}, {'measure': 'height', 'timeFrame': '8 weeks', 'description': 'in meters'}, {'measure': 'weight', 'timeFrame': '8 weeks', 'description': 'in kg'}, {'measure': 'BMI', 'timeFrame': '8 weeks', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}], 'secondaryOutcomes': [{'measure': 'wellbeing', 'timeFrame': '8 weeks', 'description': 'self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)'}, {'measure': 'Stress level', 'timeFrame': '8 weeks', 'description': 'self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress'}, {'measure': 'Qualitative Descriptive', 'timeFrame': 'At end of 8 weeks', 'description': 'interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caregiver', 'dementia', 'wellbeing', 'stress'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': "This study aims to:\n\n1. Establish the feasibility of a health-coached (HC) walking program utilizing motivational interviewing (MI) and wireless pedometers in family caregivers of persons with dementia.\n2. Examine preliminary outcomes of a HC walking program utilizing MI with wireless pedometers on family caregiver's perception of wellbeing, stress, and activity level.\n3. Explore caregivers' acceptability and experience of participating in a HC walking program utilizing MI with wireless pedometers and to explore additional person centered approaches.", 'detailedDescription': 'This comparative study will use a two group repeated measure design and mixed methods approach including well-validated questionnaires and qualitative descriptive methodology. Qualitative inquiry will provide data about the overall experience of caregivers in the intervention arm as well as inform web-based, person centered approaches as suggested by caregivers that will be used to inform future work on person-centered self-care strategies, aimed at improving caregiver health. Eligibility Criteria: having approval from the primary care provider to initiate a walking program, being a caregiver of a person with dementia, being greater than 18 years of age and having access to a computer or smartphone. "The "RSVP \\[research volunteer program\\] for Health," a registry comprised of individuals interested in receiving information on research studies conducted at Massachusetts General Hospital (MGH), will be utilized for recruitment. If a person states they are interested, they will be called to set up a screening visit to determine study eligibility at which time they will be given the IRB consent to review and a baseline visit will be set up.\n\nAt the baseline visit, the consent will be reviewed by the Principal Investigator (PI) and signed by participants meeting eligibility criteria. A member of the study team will obtain demographic and caregiver health characteristics and complete study questionnaires. After baseline measures are obtained, the study team will: 1) provide all participants with education about the CDC physical activity recommendations for adults, 2) set participants up with a wireless pedometer and 3) invite them to join a walking group on-line where they can monitor their activity as compared to others in the intervention arm. Members of the study team will then provide participants in the intervention arm with health coaching (HC) utilizing motivational interviewing (MI) weekly for 8 weeks by email, text message or telephone. The mode of delivery for the MI will be based on participant preference. The control group will be able to view the web page and monitor their activity compared to others in the control group arm, but will receive no coaching." At the end of the 8 weeks, study measures will be again be obtained in both groups. The PI will conduct semi-structured qualitative interviews with participants in the intervention arm to evaluate acceptability and acquire feedback on the intervention and ideas for other self-care strategies." Caregiver Measures Pre - Post\n\n1. Demographic variables\n2. General health characteristics\n3. Well-being\n4. Perceived stress\n5. Mini-cog\n6. Perceived Steps And post, a qualitative interview'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - must have/be:\n\nApproval from the primary care provider to initiate a walking program A caregiver of a person with dementia Greater than age 18 Access access to a computer or smartphone.\n\nExclusion Criteria:\n\nNot being able to commit to an 8 week walking program'}, 'identificationModule': {'nctId': 'NCT04423666', 'briefTitle': 'Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Boston College'}, 'officialTitle': 'Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia', 'orgStudyIdInfo': {'id': 'BostonCollege'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Will receive:\n\n1. education\n2. a wireless pedometer with set up\n3. nurse coaching via text message, email or telephone based on participant preference and at frequency determined by the participant', 'interventionNames': ['Behavioral: Walking using a wireless pedometer']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Will receive:\n\n1. education\n2. a wireless pedometer with set up', 'interventionNames': ['Behavioral: Walking using a wireless pedometer']}], 'interventions': [{'name': 'Walking using a wireless pedometer', 'type': 'BEHAVIORAL', 'description': 'See arm/group', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jane Flanagan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston College'}]}, 'ipdSharingStatementModule': {'url': 'http://www.bc.edu/bc-web/schools/cson/faculty-research/faculty-directory/jane-m--flanagan.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'April 2020 - indefinitely', 'ipdSharing': 'YES', 'description': 'The Pi will make available upon request the study protocol, SAP, ICF and CSR and as possible these will be shared via dissemination of the findings.', 'accessCriteria': 'notify PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}