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Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture (B2F)

25. oktober 2017 opdateret af: Dolores Langford, University of British Columbia

A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture

The purpose of this study is to determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators propose a randomized controlled trial design to inform the development of a larger scale study to test effectiveness of a clinician supported telephonic self management intervention for older adults after hip fracture. The primary aim is to determine feasibility and acceptability of the intervention, and the secondary aim is to measure statistical trends on quality of life at 4 months after fracture in community dwelling older adults. In parallel, we will conduct a process evaluation to ascertain key features of the intervention via qualitative interviews of participants and health care professionals involved in delivery of the intervention.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lions Gate Hospital

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

60 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults (men and women) over 60 years of age
  • Fall related hip fracture
  • Community dwelling
  • English speaking

Exclusion Criteria:

  • Dementia
  • Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
  • Profound hearing loss

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Education Only
  • A 1 hour education session in the acute setting
  • A toolkit with education, exercise and self management instructions for after hip fracture
Adfærdsmæssigt: Education Only
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
Eksperimentel: Education + Telephone Follow-up
  • A 1 hour education session in the acute setting
  • A telephone delivered self management program , including a toolkit (education, exercise and self management instructions for after hip fracture), support to take an active role in recovery, including setting and monitoring goals, problem solving mobility barriers, and guidance on the recovery process following a hip fracture.
Adfærdsmæssigt: Education Only
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
Adfærdsmæssigt: Telephone Support and Coaching

The participants will receive up to 5 telephone calls of 30-45 minutes each after hospital discharge to provide support and education for the transition from acute to community care. The first call will be made within 48-72 hours of hospital discharge and will have the following elements:

  • Health Status
  • Medication Management
  • Activity/Exercise Prescription and Goal-Setting
  • Falls Prevention
  • Clarification of Appointments
  • Coordination of Post-Discharge Home Services
  • What To Do If a Problem Arises

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of study recruitment and retention
Tidsramme: 1 year
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life EQ5D-5L
Tidsramme: 4 months
The EQ5D-5L Quality of Life outcome measure is a self reported questionnaire measure, and has been extensively investigated in the hip fracture population, with well established sensitivity, reliability and validity properties.
4 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life ICECAP-O
Tidsramme: 4 months
4 months
de Morton Mobility Index (DEMMI)
Tidsramme: 4 months
The DEMMI is a clinical instrument for measuring mobility in older adults. Interval levels are obtained from 0 (poor mobility) to 100 (excellent mobility)
4 months
Gait (Walking) speed
Tidsramme: 4 months
Gait speed is a reliable, valid and sensitive measure likened to a vital sign.
4 months
Falls FES-1
Tidsramme: 4 months
Falls self efficacy questionnaire will be used.
4 months
Pain: Visual Analogue Scale (VAS)
Tidsramme: 4 months
4 months
Falls self report diary
Tidsramme: 4 months
Participants will record Falls in a check box format daily
4 months
The Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 4 months
The HADS is a 14 item self reported questionnaire designed to assess anxiety and depression
4 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of British Columbia

Efterforskere

  • Ledende efterforsker: Dolores P Langford, Msc., Vancouver Coastal Health
  • Studieleder: Maureen C Ashe, PhD, Centre for Hip Health and Mobility

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. november 2013

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

31. juli 2013

Først indsendt, der opfyldte QC-kriterier

23. august 2013

Først opslået (Skøn)

28. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H13-01810

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 .

Kliniske forsøg med Hoftebrud

Kliniske forsøg med Education Only

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Spain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner