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

25. april 2016 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3M 0B2
        • Rekruttering
        • Humber River Hospital - Wilson Site
      • Toronto, Ontario, Canada, M8Z 6A4
        • Aktiv, ikke rekrutterende
        • St. Joseph's Health Centre - Satellite Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
Annen: 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.
Ingen inngripen: Control
The 16-week exercise program involving activities during dialysis, at home, and in the community.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Change in number of steps using a pedometer
Tidsramme: 0, 8, 16, 28 weeks
0, 8, 16, 28 weeks
Change in basic mobility using the Timed Up and Go
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1-16, 28 weeks
1-16, 28 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Toronto Rehabilitation Institute

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)

Etterforskere

  • Hovedetterforsker: Pia Kontos, PhD, University Health Network, Toronto

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2014

Primær fullføring (Forventet)

1. september 2016

Studiet fullført (Forventet)

1. mars 2017

Datoer for studieregistrering

Først innsendt

21. april 2016

Først innsendt som oppfylte QC-kriteriene

25. april 2016

Først lagt ut (Anslag)

28. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. april 2016

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14-7507-DE

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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