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Alzheimer Disease : Rehabilitation's Intervention at Home (pré MATAPA)

14. Oktober 2014 aktualisiert von: Nantes University Hospital

Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.

Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its prevalence and its medical and social consequences, AD represents a dual challenge to public health and society. The elderly want to stay in their homes even when their lives are altered by a chronic progressive disease. Their caregivers claim in turn a support at home. But this desire is questioned because of the characteristics of the disease, e.g. the altered relational function by the cognitive impairment and the behavioural disorders associated.

Outpatients non-drug therapies represent a potential support that adapts to patient with an AD or mixed dementia, especially in their milder forms.

The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention at home and its acceptability by both the patient and the caregiver.

The study of its efficiency in terms of autonomy will be the next step.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The protocol is based on weekly rehabilitation's intervention at home. All home visits and assessments of the patient and his caregiver will be made by the rehabilitation's therapist himself.

Twelve weekly interventions at home are planed. The first five are needed to define a realistic and achievable goal of treatment which is accepted by the dyad and the therapist. The following seven interventions will achieve this goal by rehabilitation's intervention (e.g. occupational therapy, psychomotor approach).

Four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after inclusion and 3 months after the last intervention).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

17

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Frankreich
      • Nantes, Frankreich, 44093
        • Bellier Hospital, CHU of Nantes

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Patient's inclusion criteria:

  • Aged 65 and over
  • AD or mixed dementia (DSM IV TR criteria), documented by a neuropsychological assessment and a brain imaging
  • Living at home
  • Having a caregiver (more than 2 visits per week)
  • Agreement for the study

Caregiver's inclusion criteria :

  • More than 2 patient's visits per week
  • Agreement for the study

Patient's exclusion criteria:

  • Life expectancy less than 1 year
  • Guardianship
  • Already having a rehabilitation program's therapy
  • Participation in a pharmacological study

Caregiver's exclusion criteria:

- Medical condition requiring regular care

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Home rehabilitation therapy
12 weekly sessions of Home rehabilitation therapy
Verhalten: Home rehabilitation therapy
12 sessions of home rehabilitation therapy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Zeitfenster: 27 weeks
The main objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
27 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Zeitfenster: 5 weeks
This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the fifth weekly session of at home rehabilitation therapy).
5 weeks
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Zeitfenster: 13 weeks
This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).
13 weeks
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Zeitfenster: 27 weeks
This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
27 weeks
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Zeitfenster: 5 weeks
This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).
5 weeks
Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
Zeitfenster: 13 weeks
This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 12 weeks later (meaning after the last of the twelfth weekly session of at home rehabilitation therapy).
13 weeks
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Zeitfenster: 13 weeks
This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).
13 weeks
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Zeitfenster: 27 weeks
This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
27 weeks
Evaluation of the mean scores of Zarit's scale (caregiver burden)
Zeitfenster: 5 weeks
This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).
5 weeks
Alcohol consumption for the patient and the caregiver
Zeitfenster: 27 weeks
This objective is to compare the alcohol consumption for the patient and the caregiver observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
27 weeks
Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)
Zeitfenster: 27 weeks
This objective is to compare the mean scores of Mini Mental State Examination (MMSE) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
27 weeks
Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)
Zeitfenster: 27 weeks
This objective is to compare the mean scores of Goal Attainment Scales (GAS) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
27 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nantes University Hospital

Ermittler

  • Hauptermittler: Gilles Berrut, Pr, Bellier Hospital, CHU of Nantes

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2012

Primärer Abschluss (Tatsächlich)

1. Mai 2014

Studienabschluss (Tatsächlich)

1. September 2014

Studienanmeldedaten

Zuerst eingereicht

18. September 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. September 2012

Zuerst gepostet (Schätzen)

21. September 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. Oktober 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Oktober 2014

Zuletzt verifiziert

1. Oktober 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RC12_0080

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