Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 12:54 AM
Study NCT ID:
NCT01358032
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2011-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-09', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2011-05-19', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concerns about falling', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Falls Efficacy Scale International (FES-I)'}, {'measure': 'avoidance of activities due concerns about falling', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)'}], 'secondaryOutcomes': [{'measure': 'disability', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Groningen Activity Restriction Scale (GARS)'}, {'measure': 'number of falls', 'timeFrame': 'continuous registration during the course of the trial for a period of 1 year', 'description': 'Fall calendar'}, {'measure': 'catastrophic beliefs about falling', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Catastrophic beliefs about falling (CAFS)'}, {'measure': 'perceived consequences of falling', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'CoF - loss of functional independence subscale and damage to identity subscale'}, {'measure': 'perceived control over falling', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Perceived control over falling (PCOF)'}, {'measure': 'mastery', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Personal Mastery Scale'}, {'measure': 'feelings of anxiety', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Subscale of the Hospital Anxiety and Depression Scale (HADS-A)'}, {'measure': 'symptoms of depression', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Subscale of the Hospital Anxiety and Depression Scale (HADS-D)'}, {'measure': 'social support interactions', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'Social support interactions (SSL 12-I)'}, {'measure': 'health-related quality of life', 'timeFrame': 'baseline, 5 months and 12 months', 'description': 'SF-12 Health Survey'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fear of falling', 'Cognitive behavioral therapy', 'Randomized controlled trial', 'Frailty', 'Accidental Falls'], 'conditions': ['Concerns About Falling', 'Aged']}, 'referencesModule': {'references': [{'pmid': '22367355', 'type': 'BACKGROUND', 'citation': "Dorresteijn TA, Rixt Zijlstra GA, Van Eijs YJ, Vlaeyen JW, Kempen GI. Older people's preferences regarding programme formats for managing concerns about falls. Age Ageing. 2012 Jul;41(4):474-81. doi: 10.1093/ageing/afs007. Epub 2012 Feb 23."}, {'pmid': '21933436', 'type': 'BACKGROUND', 'citation': 'Dorresteijn TA, Zijlstra GA, Delbaere K, van Rossum E, Vlaeyen JW, Kempen GI. Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032]. BMC Health Serv Res. 2011 Sep 20;11:228. doi: 10.1186/1472-6963-11-228.'}, {'pmid': '39360568', 'type': 'DERIVED', 'citation': 'Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.'}, {'pmid': '37026185', 'type': 'DERIVED', 'citation': 'Kruisbrink M, Zijlstra GAR, Crutzen R, Dorresteijn TAC, Winkens B, Kempen GIJM. Participant Characteristics as Moderators of the Effects of Cognitive Behavioral Interventions on Concerns About Falling: Secondary Analyses of Two Randomized Controlled Trials. J Appl Gerontol. 2023 Aug;42(8):1877-1887. doi: 10.1177/07334648231165904. Epub 2023 Apr 6.'}, {'pmid': '31502897', 'type': 'DERIVED', 'citation': 'Evers SMAA, Dorresteijn TAC, Wijnen BFM, van Haastregt JCM, Kempen GIJM, Zijlstra GAR. Economic evaluation of a home-based programme to reduce concerns about falls in frail, independently-living older people. Expert Rev Pharmacoecon Outcomes Res. 2020 Dec;20(6):641-651. doi: 10.1080/14737167.2019.1666714. Epub 2019 Sep 20.'}, {'pmid': '26739339', 'type': 'DERIVED', 'citation': 'Dorresteijn TA, Zijlstra GA, Ambergen AW, Delbaere K, Vlaeyen JW, Kempen GI. Effectiveness of a home-based cognitive behavioral program to manage concerns about falls in community-dwelling, frail older people: results of a randomized controlled trial. BMC Geriatr. 2016 Jan 6;16:2. doi: 10.1186/s12877-015-0177-y.'}, {'pmid': '23533013', 'type': 'DERIVED', 'citation': 'Dorresteijn TA, Rixt Zijlstra GA, Van Haastregt JC, Vlaeyen JW, Kempen GI. Feasibility of a nurse-led in-home cognitive behavioral program to manage concerns about falls in frail older people: a process evaluation. Res Nurs Health. 2013 Jun;36(3):257-70. doi: 10.1002/nur.21534. Epub 2013 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'The main objectives of this study are:\n\n1. an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,\n2. a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and\n3. an economical evaluation on the impact of the program on healthcare utilization and related costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 70 years or over\n* At least some concerns about falling\n* At least some associated avoidance of activity\n* Fair or poor perceived general health\n* Living independently in the community\n* Written informed consent\n\nExclusion Criteria:\n\n* Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)\n* Language or hearing problems that impede completing an interview by telephone\n* Sight problems that impede completing the intervention\n* Confinement to bed\n* Waiting for nursing home admission\n* Permanent use of a wheelchair'}, 'identificationModule': {'nctId': 'NCT01358032', 'briefTitle': 'Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community', 'orgStudyIdInfo': {'id': 'MEC 07-3-064'}, 'secondaryIdInfos': [{'id': 'ZonMw 120610001', 'type': 'OTHER_GRANT', 'domain': 'ZonMw 120610001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioral program', 'description': 'an in-home cognitive behavioral program on managing concerns about falling and associated activity avoidance in frail community-dwelling older people facilitated by trained community nurses.', 'interventionNames': ['Behavioral: an in-home cognitive behavioral program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'no program, only care as usual'}], 'interventions': [{'name': 'an in-home cognitive behavioral program', 'type': 'BEHAVIORAL', 'description': 'The in-home cognitive behavioral program aims to learn older persons, living in the community, how to deal with concerns about falling and to increase physical, social and functional activity. The principles of cognitive restructuring are used for shifting maladaptive in adaptive attitudes with respect to falling as well as increasing self efficacy beliefs and feelings of control. The following themes are discussed during the program: concerns about falling, thoughts about falling, physical exercise, assert oneself, overcome personal barriers, recognizing fall-ty habits and managing concerns about falling. Duration of the program is 10 weeks with 7 individual sessions (3 home visits (60, 60 and 75 minutes, respectively) \\& 4 telephone contacts (35 minutes each). The program is facilitated by trained nurses qualified in the field of geriatrics and working for home care agencies.', 'armGroupLabels': ['Cognitive behavioral program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6221 GT', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}