- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01829594
Case Managers to Frail Older People a Randomized Controlled Trial
9. april 2013 opdateret af: Jimmie Kristensson, Lund University
The aim of is to test the effects of a model for care (case management) to older people with high healthcare consumption and functional dependency on healthcare consumption, quality of life, functional ability and experiences of care.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
153
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lund, Sverige, SE-22100
- Lund University, Faculty of Medicine, Department of Health Sciences
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- aged 65 or over
- need help with at least two activities of daily living
- been admitted to hospital on at least two occasions, or
- have had at least four contacts with outpatient or primary care during the previous twelve months,
- be able to communicate verbally
- have no cognitive impairment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Sagsbehandling
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Nurses and a physiotherapist (PT) worked as case managers (CM).
The intervention lasted 12 months and comprised 4 dimensions.
The first was traditional CM tasks: assessment, planning, monitoring, care coordination and evaluation.
Home visits were made at least once a month.
The second and third was general and specific information related to the participants' situation.
The fourth part included aspects of continuity and safety.
The PT also paid home visits and made an assessment regarding physical function and balance.
The intervention consisted of multidimensional prevention of falls and/or consequences of falls, and supporting and motivating the participant to increased physical activity.
When those in the control group had participated for 12 months they were offered the intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Health care consumption
Tidsramme: two years (one year before vs after baseline)
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two years (one year before vs after baseline)
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Health care costs
Tidsramme: two years (one year before vs after baseline)
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two years (one year before vs after baseline)
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Feelings of loneliness
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Depressive symptoms
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Health Related Quality of Life
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Number of falls
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Life Satisfaction
Tidsramme: baseline and then after 6,12,24 months
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baseline and then after 6,12,24 months
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Health complaints
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Knowledge about prescribed drugs
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Attitudes towards prescribed drugs
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Drug use
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Activities and social participation
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Functional capacity
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Balance
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Timed up and go (TUG)
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Risk of falling
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Fear of Falling
Tidsramme: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Experiences of care
Tidsramme: approximately one year
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qualitative interviews with participants, next of kins and case managers
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approximately one year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ingalill Rahm Hallberg, PhD, Lund University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2006
Primær færdiggørelse (Faktiske)
1. april 2011
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
9. april 2013
Først indsendt, der opfyldte QC-kriterier
9. april 2013
Først opslået (Skøn)
11. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 499/2008
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .