Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People
9. juli 2012 oppdatert av: Maastricht University Medical Center
Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community
The main objectives of this study are:
- 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,
- 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
- an economical evaluation on the impact of the program on healthcare utilization and related costs.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
389
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maastricht, Nederland, 6221 GT
- Maastricht University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Aged 70 years or over
- At least some concerns about falling
- At least some associated avoidance of activity
- Fair or poor perceived general health
- Living independently in the community
- Written informed consent
Exclusion Criteria:
- Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
- Language or hearing problems that impede completing an interview by telephone
- Sight problems that impede completing the intervention
- Confinement to bed
- Waiting for nursing home admission
- Permanent use of a wheelchair
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Cognitive behavioral program
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.
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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.
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Ingen inngripen: Control group
no program, only care as usual
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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concerns about falling
Tidsramme: baseline, 5 months and 12 months
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Falls Efficacy Scale International (FES-I)
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baseline, 5 months and 12 months
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avoidance of activities due concerns about falling
Tidsramme: baseline, 5 months and 12 months
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Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)
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baseline, 5 months and 12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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disability
Tidsramme: baseline, 5 months and 12 months
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Groningen Activity Restriction Scale (GARS)
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baseline, 5 months and 12 months
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number of falls
Tidsramme: continuous registration during the course of the trial for a period of 1 year
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Fall calendar
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continuous registration during the course of the trial for a period of 1 year
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catastrophic beliefs about falling
Tidsramme: baseline, 5 months and 12 months
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Catastrophic beliefs about falling (CAFS)
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baseline, 5 months and 12 months
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perceived consequences of falling
Tidsramme: baseline, 5 months and 12 months
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CoF - loss of functional independence subscale and damage to identity subscale
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baseline, 5 months and 12 months
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perceived control over falling
Tidsramme: baseline, 5 months and 12 months
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Perceived control over falling (PCOF)
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baseline, 5 months and 12 months
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mastery
Tidsramme: baseline, 5 months and 12 months
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Personal Mastery Scale
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baseline, 5 months and 12 months
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feelings of anxiety
Tidsramme: baseline, 5 months and 12 months
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Subscale of the Hospital Anxiety and Depression Scale (HADS-A)
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baseline, 5 months and 12 months
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symptoms of depression
Tidsramme: baseline, 5 months and 12 months
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Subscale of the Hospital Anxiety and Depression Scale (HADS-D)
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baseline, 5 months and 12 months
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social support interactions
Tidsramme: baseline, 5 months and 12 months
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Social support interactions (SSL 12-I)
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baseline, 5 months and 12 months
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health-related quality of life
Tidsramme: baseline, 5 months and 12 months
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SF-12 Health Survey
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baseline, 5 months and 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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. Erratum In: BMC Geriatr. 2016;16:108.
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2009
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
17. mai 2011
Først innsendt som oppfylte QC-kriteriene
19. mai 2011
Først lagt ut (Anslag)
23. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. juli 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juli 2012
Sist bekreftet
1. juli 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- MEC 07-3-064
- ZonMw 120610001 (Annet stipend/finansieringsnummer: ZonMw 120610001)
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