Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-31 @ 7:11 PM
Study NCT ID:
NCT01577134
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personal Resources of Elderly People With Multimorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in physical activity', 'timeFrame': 'Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in quality of Life', 'timeFrame': 'Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months'}, {'measure': 'Change in self-reported perceived autonomy', 'timeFrame': 'Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multimorbidity', 'autonomy', 'older adults', 'physical activity', 'intervention', 'behavior change'], 'conditions': ['Multimorbidity']}, 'descriptionModule': {'briefSummary': 'PREFER II aims at developing psychological targeted theory- and evidence-based intervention components, which support older people with multiple illnesses in performing more physical activity. Many studies provide evidence for the importance of physical activity as a central mediator of health. This means that determinants of physical activity such as personal resources constitute an ideal target for interventions.\n\nWithin PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning and self-monitoring will be targeted in the interventions. These factors are important both for motivating older people with multiple illnesses to change their health behaviors and to translate such motivation into behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '64 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 64 years or older\n* community-residing\n\nExclusion Criteria:\n\n* regularly exercising'}, 'identificationModule': {'nctId': 'NCT01577134', 'acronym': 'PREFER', 'briefTitle': 'Personal Resources of Elderly People With Multimorbidity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'German Centre of Gerontology'}, 'officialTitle': 'Personal Resources of Elderly People With Multimorbidity: Fortification of Effective Health Behaviour', 'orgStudyIdInfo': {'id': '01ET1001B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention to enhance physical activity', 'description': 'Participants in this arm have high motivation to be regularly physically active. Face-to-face group intervention includes behavior change techniques to enhance physical activity.', 'interventionNames': ['Behavioral: Social-cognitive resource intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control intervention', 'description': 'Face-to-face group intervention includes behavior change techniques to enhance volunteering and improve attitudes towards volunteering.', 'interventionNames': ['Behavioral: Social-cognitive resource intervention']}, {'type': 'OTHER', 'label': 'Passive control intervention', 'description': 'Waiting-list control group, who receives all information (that the active groups got) via mail after completion of 8.5 months follow-up.', 'interventionNames': ['Behavioral: no intervention']}], 'interventions': [{'name': 'Social-cognitive resource intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention group that receives a behavior change technique intervention to increase volitional strategies and physical activity.', 'armGroupLabels': ['Intervention to enhance physical activity']}, {'name': 'Social-cognitive resource intervention', 'type': 'BEHAVIORAL', 'description': 'Active control group that receives a behavior change technique intervention to increase volitional strategies and volunteering.', 'armGroupLabels': ['Active control intervention']}, {'name': 'no intervention', 'type': 'BEHAVIORAL', 'description': 'Passive control group that receives no intervention until the 8.5 months follow-up. Subsequently, they receive the information by mail the active groups received within the intervention.', 'armGroupLabels': ['Passive control intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12101', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Centre of Gerontology', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Clemens Tesch-Römer, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'German Centre of Gerontology'}, {'name': 'Ralf Schwarzer, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Freie Universität Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Centre of Gerontology', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'Freie Universität Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}