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Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy

25 avril 2016 mis à jour par: Pia Kontos, Toronto Rehabilitation Institute
Exercise training for older hemodialysis patients can greatly improve many of the negative effects and poor health outcomes associated with end-stage kidney disease. Exercise has yet to be incorporated effectively and systematically into routine care. Exercise programs remain rare. When such programs are implemented, their participation rates vary, and they neglect home and community-based activities, as well as the involvement of family caregivers to support and reinforce exercise. This study is intended to address these limitations by introducing a highly accessible and compelling educational film, Fit for Dialysis, designed to introduce, motivate, and sustain exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by family caregivers, nephrologists, and nurses. The objective of this clinical trial is to determine whether and in what ways Fit for Dialysis improves outcomes and influences knowledge/attitudes regarding the importance of exercise-based principles of wellness in the context of end-stage renal disease. Ultimately Fit for Dialysis could be used as a model for dialysis education that supports guideline recommendations that exercise be incorporated into the care and treatment of dialysis patients.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

The study introduces a highly accessible and compelling educational film designed to introduce, motivate, and sustain patient exercise for wellness amongst older hemodialysis patients, and exercise counseling and support by nephrology staff and family caregivers. Fit for Dialysis is a filmed drama that is based on focus group research with older hemodialysis patients, family caregivers, and health care practitioners that highlighted patients' desire to exercise as well as discouragement of patients to do so by overprotective families, and nurses' preferences for patient sedentariness during hemodialysis. Fit for Dialysis was tailored to the exigencies of out-patient hemodialysis settings by acknowledging and providing a roadmap to overcome the disciplinary silos and paternalism towards patients which inhibit exercise during hemodialysis, and highlighting some of the life circumstances that may influence patients' self-management of exercise behaviours at home and in the community.

In order to advance our understanding of the ways in which Fit for Dialysis influences participant outcomes, a prospective 2-site parallel intervention trial will be implemented that will compare the film + a 16-week exercise program in one hospital, with a 16-week exercise-only program in another hospital. Each hospital will have a 12-week follow-up. Qualitative and quantitative methods will be used including semi-structured interviews, and physical fitness and activity measures. These data will be used to explore the impact of Fit for Dialysis on: the knowledge/attitudes of patients, family caregivers, and staff regarding exercise-based principles of wellness; the education, motivation, or maintenance of patient exercise during dialysis, at home, and in the community; adherence to exercise prescription; and patient physical fitness and activity outcomes. The study will also explore factors related to family caregivers, nephrologists, nurses, and hospital administrators, and patients' home and community environments that may impact the successful uptake of the key messages of Fit for Dialysis.

In the intervention site (film+exercise hospital), 30 patients will view Fit for Dialysis and participate in the exercise program; at the exercise-only hospital, 30 patients will only exercise. A family caregiver of each participating patient will either view Fit for Dialysis and read an information letter on the benefits and contraindications of exercise (in the film+exercise hospital), or will only read the information letter (in the exercise-only hospital). In the film+exercise hospital, five nephrologists, 10 nurses and 3 administrators will also view the film. In both hospitals, 10 patients, 10 family caregivers, 10 nurses, 5 nephrologists, 3 administrators, and the physiotherapist assistants will be interviewed.

Type d'étude

Interventionnel

Inscription (Anticipé)

60

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3M 0B2
        • Recrutement
        • Humber River Hospital - Wilson Site
      • Toronto, Ontario, Canada, M8Z 6A4
        • Actif, ne recrute pas
        • St. Joseph's Health Centre - Satellite Site

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:

  • Have conversational ability in English
  • Have a medical diagnosis of hemodialysis-dependent end-stage renal disease
  • Are a registered hemodialysis patient in the hospital for at least 3 months
  • Receive ≥ 2 in-centre hemodialysis sessions per week
  • Are ambulatory (with or without aids)
  • Are deemed medically eligible by their nephrologist to participate in an exercise program that includes stretching, strengthening, and cardiovascular components
  • Have a family caregiver who agrees to participate in the exercise program and keep a log of exercises on non-dialysis days

Exclusion Criteria:

  • Currently participating in regular physical activity (structured exercise that includes a cardiovascular and/or strengthening component ≥ 3 times/week for ≥ 10 min/session

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: Recherche sur les services de santé
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention
A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
Autre: Fit for Dialysis
A 15-minute research-based film that explores the barriers and facilitators regarding exercise participation by older hemodialysis patients and support by nephrology staff and family caregivers, and a 16-week exercise program involving activities during dialysis, at home, and in the community.
Aucune intervention: Control
The 16-week exercise program involving activities during dialysis, at home, and in the community.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
Délai: 1-16 weeks
1-16 weeks
Change in functional exercise capacity measured by the 2-Minute Walk Test
Délai: 0, 8, 16, 28 weeks
0, 8, 16, 28 weeks

Mesures de résultats secondaires

Mesure des résultats
Délai
Change in number of steps using a pedometer
Délai: 0, 8, 16, 28 weeks
0, 8, 16, 28 weeks
Change in basic mobility using the Timed Up and Go
Délai: 0, 8, 16, 28 weeks
0, 8, 16, 28 weeks
Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
Délai: 0, 8, 16, 28 weeks
0, 8, 16, 28 weeks
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
Délai: 0, 8, 16, 28 weeks
0, 8, 16, 28 weeks
Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
Délai: 1-16, 28 weeks
1-16, 28 weeks

Collaborateurs et enquêteurs

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

Parrainer

Toronto Rehabilitation Institute

Collaborateurs

Canadian Institutes of Health Research (CIHR)

Les enquêteurs

  • Chercheur principal: Pia Kontos, PhD, University Health Network, Toronto

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 avril 2014

Achèvement primaire (Anticipé)

1 septembre 2016

Achèvement de l'étude (Anticipé)

1 mars 2017

Dates d'inscription aux études

Première soumission

21 avril 2016

Première soumission répondant aux critères de contrôle qualité

25 avril 2016

Première publication (Estimation)

28 avril 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

28 avril 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 avril 2016

Dernière vérification

1 avril 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 14-7507-DE

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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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