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

14 oktober 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Home rehabilitation therapy
12 weekly sessions of Home rehabilitation therapy
Gedragsmatig: Home rehabilitation therapy
12 sessions of home rehabilitation therapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nantes University Hospital

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2012

Primaire voltooiing (Werkelijk)

1 mei 2014

Studie voltooiing (Werkelijk)

1 september 2014

Studieregistratiedata

Eerst ingediend

18 september 2012

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2012

Eerst geplaatst (Schatting)

21 september 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

15 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

14 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RC12_0080

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Locaties

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