- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02754271
Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Pia Kontos, PhD
- Numero di telefono: 7609 416-597-3422
- Email: pia.kontos@uhn.ca
Backup dei contatti dello studio
- Nome: Romeo Colobong, MA
- Numero di telefono: 7885 416-597-3422
- Email: romeo.colobong@uhn.ca
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M3M 0B2
- Reclutamento
- Humber River Hospital - Wilson Site
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Toronto, Ontario, Canada, M8Z 6A4
- Attivo, non reclutante
- St. Joseph's Health Centre - Satellite Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Intervention
A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
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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.
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Nessun intervento: Control
The 16-week exercise program involving activities during dialysis, at home, and in the community.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
Lasso di tempo: 1-16 weeks
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1-16 weeks
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Change in functional exercise capacity measured by the 2-Minute Walk Test
Lasso di tempo: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in number of steps using a pedometer
Lasso di tempo: 0, 8, 16, 28 weeks
|
0, 8, 16, 28 weeks
|
Change in basic mobility using the Timed Up and Go
Lasso di tempo: 0, 8, 16, 28 weeks
|
0, 8, 16, 28 weeks
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Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
Lasso di tempo: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
|
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
Lasso di tempo: 0, 8, 16, 28 weeks
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0, 8, 16, 28 weeks
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Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
Lasso di tempo: 1-16, 28 weeks
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1-16, 28 weeks
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Pia Kontos, PhD, University Health Network, Toronto
Pubblicazioni e link utili
Pubblicazioni generali
- Kontos P, Grigorovich A, Colobong R, Miller KL, Nesrallah GE, Binns MA, Alibhai SMH, Parsons T, Jassal SV, Thomas A, Naglie G. Fit for Dialysis: a qualitative exploration of the impact of a research-based film for the promotion of exercise in hemodialysis. BMC Nephrol. 2018 Aug 6;19(1):195. doi: 10.1186/s12882-018-0984-4.
- Kontos P, Alibhai SM, Miller KL, Brooks D, Colobong R, Parsons T, Jassal SV, Thomas A, Binns M, Naglie G. A prospective 2-site parallel intervention trial of a research-based film to increase exercise amongst older hemodialysis patients. BMC Nephrol. 2017 Jan 26;18(1):37. doi: 10.1186/s12882-017-0454-4.
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Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14-7507-DE
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