- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Herlev, Danmark, 2730
- Herlev Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: 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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Övrig: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants who have been readmitted to hospital
Tidsram: 01.03.2013 - 12.31.2014
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Number of participants who have been readmitted to hospital.
Measured 6 months after admission.
|
01.03.2013 - 12.31.2014
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mortality
Tidsram: 01.04.2014 - 31.12.2014
|
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
Tidsram: 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
Tidsram: 01.04.2013 - 31.12.2014
|
Delivered services in Primary Healthcare.
Measured 6 months after admission.
|
01.04.2013 - 31.12.2014
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tove L. Damsgaard, Herlev Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-1-2012-118
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