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Patient Participation in Prevention of Loss of Functions

30. juli 2015 opdateret af: Tove Lindhardt Damsgaard, Herlev Hospital

Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients

Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

At baseline:

Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide).

At follow-up three months after discharge:

BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized.

The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter.

Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Herlev, Danmark, 2730
        • Herlev 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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 65 years or older
  • Living in their own home with no contact to the Municipality, both before and after admission
  • Discharged from Department o105 or the Acute Receiving Unit <48 hours from admission.

Exclusion Criteria:

  • Patients with life-threatening disease in the terminal stage
  • Patients who does not speak and understand Danish
  • Patients who are not able to communicate and collaborate, with regards to the measurements

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Empowerment
Patients in the intervention group 1 receive a communication report which will also be sent to the physician and home care. In communication report includes the results and interpretation and explanation of the measurements in layman's terms. The report also includes relevant and targeted information on pain management, depression among the elderly, dementia and disability in old age and ways to maintain and improve functional capacity. Links and addresses of relevant, local organizations, and networks are also included. The information material is also included in the report sent to the General Practitioner (GP) and home care.
Adfærdsmæssigt: Empowerment
To give patients the necessary resources to take care of their own health
Andet: Conversation with Nurse
Patients in the intervention group 2 gets clarification and follow-up conversation with a nurse anchored in both medical department and municipalities. The nurse is "blinded" in relation to the patient's screening results. Problems identified in connection therewith are communicated to the GP and home care.
Andet: Conversation with nurse
To find out, if the nurse, using her ....
Ingen indgriben: Controle Group
Patients in the control group are undergoing the same measurements and records at discharge, as the intervention group, but are otherwise receiving treatment and care as usual without further intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who have been readmitted to hospital
Tidsramme: 01.03.2013 - 12.31.2014
Number of participants who have been readmitted to hospital. Measured 6 months after admission.
01.03.2013 - 12.31.2014

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality
Tidsramme: 01.04.2014 - 31.12.2014
Mortality. Number of participants, who have died. Measured 6 months after admission.
01.04.2014 - 31.12.2014
Functional ability
Tidsramme: 31.12.2014

Measured 3 months after discharge.

Functional ability

Handgrip-strength 4 second test: Hand- and forearm muscular strength in kg. and 30 second chair stand test: Lower-body muscle strength
31.12.2014
Primary Healthcare Services
Tidsramme: 01.04.2013 - 31.12.2014
Delivered services in Primary Healthcare. Measured 6 months after admission.
01.04.2013 - 31.12.2014

Samarbejdspartnere og efterforskere

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

Sponsor

Herlev Hospital

Efterforskere

  • Ledende efterforsker: Tove L. Damsgaard, Herlev Hospital

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. januar 2013

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

20. marts 2013

Først indsendt, der opfyldte QC-kriterier

28. april 2013

Først opslået (Skøn)

1. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-1-2012-118

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

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner