- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02398812
The Interprofessional Medication Assessment for Older Patients
The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Aging increases the risk of adverse effects and interactions caused by medication. Medication reconciliation and medication review are well-known practices to optimize medicines use. Both interventions usually require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. The present study focuses on medication assessment including both medication reconciliation and review combined to clinical assessment of an individual patient.
According to a systematic review there is a need for research focusing on medication management in community settings and especially to assess the impact of medication assessment on clinical outcomes.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Forssa, Finnland, FI 30100
- Welfare district of Forssa
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Haapajärvi, Finnland, FI 85800
- Selänne Basic Health Care District
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Juva, Finnland, FI-51900
- Juva Health Care
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Lahti, Finnland, FI-15100
- City of Lahti, home care
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Savonlinna, Finnland, FI-57100
- Eastern Savo Hospital District
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Home dwelling ≥65 years-old persons registered to public home care services and who
- have had dizziness, orthostatic hypotension or have fallen or
- use at least six medicines
Exclusion Criteria:
Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Active comparator
In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it
|
Intervention
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Kein Eingriff: Usual care
Usual care (reference group).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Functional capacity IADL (Instrumental Activities of Daily Living)
Zeitfenster: at 6 months from baseline
|
at 6 months from baseline
|
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Functional capacity ADL (Activities of daily living;KATZ)
Zeitfenster: at 6 months from baseline
|
at 6 months from baseline
|
|
Functional capacity TUG (Timed up and go)
Zeitfenster: at 6 months from baseline
|
at 6 months from baseline
|
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Functional capacity MMSE ( Mini-mental state examination)
Zeitfenster: at 6 months from baseline
|
at 6 months from baseline
|
|
Functional capacity GDS (Geriatric Depression Scale)-15
Zeitfenster: at 6 months from baseline
|
at 6 months from baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Use of health care services
Zeitfenster: at 6 and 12 months from baseline
|
visits to physician, hospital days and nursing care at home
|
at 6 and 12 months from baseline
|
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Need of services delivered to home
Zeitfenster: at 6 and 12 months from baseline
|
at 6 and 12 months from baseline
|
|
|
Number of medicines
Zeitfenster: at 6 and 12 months from baseline
|
at 6 and 12 months from baseline
|
|
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Quality of medicines
Zeitfenster: at 6 and 12 months from baseline
|
at 6 and 12 months from baseline
|
|
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Cost of medicines
Zeitfenster: at 6 and 12 months from baseline
|
at 6 and 12 months from baseline
|
|
|
Health related quality of life assessed with EQ-5D
Zeitfenster: at 6 and 12 months from baseline
|
at 6 and 12 months from baseline
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Pekka Mäntyselkä, MD, Professor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- ILMA
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