- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01843907
Patient Participation in Prevention of Loss of Functions
Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Herlev, Danmark, 2730
- Herlev Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 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.
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To give patients the necessary resources to take care of their own health
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Annen: 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.
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To find out, if the nurse, using her ....
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants who have been readmitted to hospital
Tidsramme: 01.03.2013 - 12.31.2014
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Number of participants who have been readmitted to hospital.
Measured 6 months after admission.
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01.03.2013 - 12.31.2014
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mortality
Tidsramme: 01.04.2014 - 31.12.2014
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Mortality.
Number of participants, who have died.
Measured 6 months after admission.
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01.04.2014 - 31.12.2014
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Functional ability
Tidsramme: 31.12.2014
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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
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Primary Healthcare Services
Tidsramme: 01.04.2013 - 31.12.2014
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Delivered services in Primary Healthcare.
Measured 6 months after admission.
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01.04.2013 - 31.12.2014
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tove L. Damsgaard, Herlev Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-1-2012-118
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