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Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial (ATUTI)

14 février 2014 mis à jour par: Louise Demers, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Experimental Control Investigation of the Impact of an Assistive Technology Updating and Tune up Intervention on the User-caregiver Dyad: a Multi-site Trial

The purpose of this study is to determine the effectiveness of an assistive technology updating and tune up intervention on users and their caregivers. This intervention includes 4 components:

  • an in-residence assessment of the mobility preferences of the older person and his/her caregiver
  • a detailed review of forms of assistance, technological and human, that are currently being used
  • recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy
  • therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver. The intervention is provided to the immediate treatment following the administration of baseline measures and the delayed intervention group six weeks later, after an additional baseline measurement. The treatment is six weeks long and the follow-up is 26 weeks.

Hypothesis 1: For community-dwelling older people, an intervention that increases the appropriateness of existing or new assistive technology(AT) for mobility or self-care will alter established patterns of human assistance, such that caregiver burden is reduced or eliminated.

Hypothesis 2: At the same time, AT users will report less difficulty in mobility or self-care, as well as enhanced subjective well-being, and satisfaction with their modified personal assistance strategy.

Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or psychological demands and increased satisfaction with their caregiving-related activities compared with

  • the pre-intervention period
  • caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical and/or psychological demands on helpers will be associated with increases in device users' satisfaction with their personal assistance strategies.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

88

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • British Columbia
      • Vancovuer, British Columbia, Canada, V6B 5K3
        • Simon Fraser University
    • Quebec
      • Montreal, Quebec, Canada
        • Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
      • Montreal, Quebec, Canada
        • the Centre de santé et des services sociaux Cavendish
      • Montreal, Quebec, Canada
        • the Centre de santé et des services sociaux de Laval

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Users: Aged 65 years and over
  • Have moderate to severe disability that limits their ability to move from place to place independently and/or to perform self-care activities.
  • Living at home
  • Receiving 2 or more hour per week of assistance with mobility and/or self-care activities from a non-professional, caregiver who is also willing to take part in the study.
  • Those caregivers will be adults aged 18 years and over.

Exclusion Criteria:

  • Assistive technology users will be excluded if they have severe aphasia, are currently on a community occupational therapist caseload, or are unable to communicate in English or French.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Immediate intervention
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
Expérimental: Delayed Intervention
Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Assessment of Life Habits
Délai: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
Caregivers: Caregiver Assistive Technology Outcome Measure
Délai: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later

Mesures de résultats secondaires

Mesure des résultats
Délai
Individually Prioritized Problem Assessment
Délai: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Functional Autonomy Measurement System
Délai: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Psychological Impact of Assistive Devices Scale
Délai: Imediately after intervention. 16 weeks later
Imediately after intervention. 16 weeks later
Satisfaction with Personal Assistance Strategy
Délai: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Louise Demers, PhD, Université de Montréal

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2009

Achèvement primaire (Réel)

1 août 2011

Achèvement de l'étude (Réel)

1 août 2011

Dates d'inscription aux études

Première soumission

24 juin 2009

Première soumission répondant aux critères de contrôle qualité

24 juin 2009

Première publication (Estimation)

25 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 février 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 février 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CRIUM-8317
  • NIDRR: H133A060062

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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