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The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program (SICAM)

25. september 2015 opdateret af: Connie Berthelsen, University of Aarhus

The SICAM-trial: Studying the Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program During and After Total Hip Replacement - A Quasi-experimental Study With a Complex Intervention

Patients in fast-track programmes are required to take an active part in their treatment and rehabilitation. Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay - yet they are seldom invited to participate in a supporting role. The aim of this study is to investigate the effect of spouses' involvement in older patients fast-track treatment programs using case management as intervention. A two-group quasi-experimental design with pre-test and repeated post-test measures (protocol approved in November 2012) was used. Patients aged 65 years or older going through a fast-track programme for a total hip replacement and their spouses was recruited in dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control group (n=14). Data was collected from both groups at baseline, two weeks and three months after surgery. Outcome measures for patients include: functional status, nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Ikke anvendelig

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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria: Patients

  • 65 years of age or older
  • undergoing a total hip replacement due to arthritis
  • live with their spouses
  • speak, read and understand Danish without an interpreter
  • have their spouses present at the mandatory pre-information meeting in the outpatient facilities.

Inclusion Criteria: Spouses

  • presence at the pre-information meeting

Exclusion Criteria: Patients

  • They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs

Exclusion criteria: Both

  • Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE)
  • Index score of <6 assessed on the Charlson Comorbidity Index

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Case management
Before admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan. During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals. During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan. After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting.
Adfærdsmæssigt: Sagsbehandling
Andet: Control group
Spouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff. The usual care and information is provided before admission in the out-patient facilities and during admission
Adfærdsmæssigt: Kontrolgruppe

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale
Tidsramme: Three months
Three months
Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI)
Tidsramme: Three months
Three months

Sekundære resultatmål

Resultatmål
Tidsramme
Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF)
Tidsramme: Three months
Three months
Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS)
Tidsramme: Three months
Three months
Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15)
Tidsramme: Three months
Three months
Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI)
Tidsramme: Three months
Three months
Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale
Tidsramme: Three months
Three months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Aarhus

Samarbejdspartnere

Lund University

Efterforskere

  • Ledende efterforsker: Connie B Berthelsen, PhD, University of Aarhus

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. august 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

21. september 2015

Først indsendt, der opfyldte QC-kriterier

25. september 2015

Først opslået (Skøn)

28. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • SICAM2015

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 .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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