- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06264362
Udvikling af en ikke-farmakologisk smerteintervention til ældre voksne med demens i lokalsamfundet
Formålet med denne undersøgelse er at udvikle et træningsbehandlingsprogram for knæartrose, der fungerer godt for mennesker med hukommelsesproblemer. Denne undersøgelse vil omfatte to dele. Deltagerne kan vælge at deltage i den ene eller begge dele.
I del 1 - Efterforskerne inviterer følgende personer til at deltage i et interview:
- Personer på 60 år eller ældre, som ikke bor på plejehjem og har både hukommelsesproblemer og knæsmerter.
- Plejepartnere til mennesker med knæsmerter og hukommelsesproblemer. En plejepartner kan være et familiemedlem eller en ven, der hjælper regelmæssigt.
- Klinikere (motionsfysiologer eller rehabiliteringsterapeuter som fysio- og ergoterapeuter), der har arbejdet med ældre voksne med hukommelsesproblemer og knæsmerter.
Målet med disse interviews er at lære af erfaringerne fra mennesker med hukommelsesproblemer og knæsmerter og dem, der plejer dem. Ud fra disse interviews håber efterforskerne at designe et ikke-medicinsk, skræddersyet fysisk aktivitetsprogram, der vil være interessant og nyttigt til at håndtere knæsmerter for ældre voksne med hukommelsesproblemer.
For personer med hukommelsesproblemer og knæsmerter og deres plejepartnere: Efterforskerne vil stille nogle spørgsmål for at bestemme egnetheden til at deltage i undersøgelsen.
De, der kvalificerer sig til undersøgelsen, vil blive inviteret til at deltage i et interview, der kan gennemføres online eller personligt (Philadelphia, PA). Interviewet kan vare op til 90 minutter (1 og en halv time) og kan gennemføres som en eller flere sessioner.
For klinikere: Deltagerne vil deltage i en 90-minutters fokusgruppe med andre klinikere, hvor frokosten vil blive serveret, hvis de er personligt. De, der deltager i en online fokusgruppe, vil modtage et gavekort svarende til værdien af frokosten.
I del 2 - Programmet udviklet i del 1 vil blive testet. Programmet vil være fysisk aktivitetsbaseret. Specifikke programdetaljer for del 2 vil blive givet, efterhånden som de dukker op. Deltagerne kan vælge at tilmelde sig den ene eller begge dele. At tilmelde sig del 1 betyder ikke, at deltagerne skal tilmelde sig del 2.
Kontakt os venligst for spørgsmål.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Annalisa Na, PT, PhD
- Telefonnummer: 2673595889
- E-mail: an838@drexel.edu
Undersøgelse Kontakt Backup
- Navn: Ben Senderling
- Telefonnummer: 2673595655
- E-mail: bms322@drexel.edu
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Drexel University
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Kontakt:
- Annalisa Na, PT, PhD
- Telefonnummer: 267-359-5889
- E-mail: an838@drexel.edu
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Kontakt:
- Ben Senderling, MS
- Telefonnummer: 2673595655
- E-mail: bms422@drexel.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier for mennesker, der lever med demens:
- Alder 60 eller ældre
- Taler engelsk
- Mild/Meget Mild demens
- Knæsmerter, der varer ≥ 3 måneder, potentielt relateret til arthritis
- Knæsmerter er mindst 2 ud af 10 i gennemsnit.
Eksklusionskriterier for personer, der lever med demens:
- Bo på et langtidsplejehjem
- Ude af stand eller villig til at give samtykke
- Har en tilstand med en forventet levetid på mindre end 1 år
- Ingen plejepartner, der også er villig til at deltage
- Nylige ændringer af smerte eller psykotrope medicin inden for de sidste 60 dage
- Nylig knæoperation i det sidste 1-år
- Har en tilstand, der kontraindicerer træning (kun fase 2)
- Modtager i øjeblikket genoptræningstjenester (kun fase 2)
For plejepartnere:
- Ingen køn, køn eller alderskriterier
- Har kendt person, der lever med demens ≥ 1 år
- Taler engelsk
- Kan og er villig til at give samtykke, herunder at blive optaget
For klinikere:
- Ingen køn, køn eller alderskriterier
- Taler engelsk
- Har ≥ 2 års erfaring med at arbejde med samfundsboende mennesker med demens og smerter
- Kan og er villig til at give samtykke, herunder at blive optaget
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Skræddersyet fysisk aktivitetsprogram til smerte
Specifikke karakteristika for interventionen leveret i fase 2 vil være baseret på information indsamlet fra interessenter i fase 1.
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Tilpasning af fysisk aktivitet som intervention til smertebehandling ved hjælp af den 3-trins skræddersyede tilgang: vurdering i trin 1 af personen, der lever med demens (PLWD), i trin 2 miljøet og i trin 3 omsorgsgiveren.
Med denne tilgang kan traditionelle øvelser tilpasses til 1) funktionelle aktiviteter (f.eks. trappegang), der er skræddersyet til PLWDs interesser (f.eks. dans, boksning) og bevarede evner; 2) foretrukne og veltolererede miljøer (f.eks. hjemmet); og 3) redegøre for omfanget og typen af interventions- og omsorgspersonens involvering.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Program parametre
Tidsramme: Dag 1
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Kvalitative interviews for at bestemme foretrukne programparametre.
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Dag 1
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Program parametre
Tidsramme: Dag 1
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Fokusgrupper af klinikere for at bestemme foretrukne programparametre.
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Dag 1
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Gennemførlighed af interventionsforanstaltning
Tidsramme: Ved studieafslutning i gennemsnit 8 uger
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Feasibility of Intervention Measure er en standardiseret 4-spørgsmåls selvrapporteret resultatmål for at vurdere gennemførligheden.
Hvert punkt bedømmes på en 5-trins skala, hvor 1 = helt uenig, 2 = uenig, 3 = hverken enig eller uenig, 4 = enig, 5 = helt enig.
Svarene summeres og varierer mellem 5 og 20, hvor højere score indikerer større gennemførlighed.
En score på 16 eller højere antyder, at programmet er gennemførligt, 15 til 9 angiver, at programmet kan være gennemførligt, og en score på 8 eller mindre antyder, at programmet ikke er gennemførligt.
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Ved studieafslutning i gennemsnit 8 uger
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Opfattelse af programmet
Tidsramme: Ved studieafslutning i gennemsnit 8 uger
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Kvalitativt interview af alle, der deltog i programmet for at bestemme komponenter af interventionsprototypen, der skal revideres
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Ved studieafslutning i gennemsnit 8 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Numerisk smertescore
Tidsramme: Gennem studieafslutning i gennemsnit 8 uger.
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En selvrapporteret smertemåling fra 0 (ingen smerte) til 10 (værste smerte).
En høj score indikerer mere smerte.
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Gennem studieafslutning i gennemsnit 8 uger.
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Zarit Burden Interview-Kort formular
Tidsramme: Ved studieafslutning i gennemsnit 8 uger
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Zarit Burden Interview-Short Form er et spørgeskema med 12 punkter til vurdering af plejebyrden ved hjælp af en 5-trins skala, hvor 0 (aldrig) til 4 (næsten altid).
Der summeres scorer fra 0-48, hvor en højere score indikerer en større plejebyrde.
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Ved studieafslutning i gennemsnit 8 uger
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Annalisa Na, PT, PhD, Drexel University
Publikationer og nyttige links
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Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
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Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
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Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Psykiske lidelser
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Kognitiv dysfunktion
- Slidgigt
- Slidgigt, knæ
- Kronisk smerte
- Mobilitetsbegrænsning
- Demens
Andre undersøgelses-id-numre
- K23AG081547 (U.S. NIH-bevilling/kontrakt)
- 1K23AG081547-01 (U.S. NIH-bevilling/kontrakt)
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Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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