Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
Primary Purpose
End-Stage Renal Disease
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fit for Dialysis
Sponsored by
About this trial
This is an interventional health services research trial for End-Stage Renal Disease
Eligibility Criteria
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
Sites / Locations
- Humber River Hospital - Wilson SiteRecruiting
- St. Joseph's Health Centre - Satellite Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
The 16-week exercise program involving activities during dialysis, at home, and in the community.
Outcomes
Primary Outcome Measures
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
Change in functional exercise capacity measured by the 2-Minute Walk Test
Secondary Outcome Measures
Change in number of steps using a pedometer
Change in basic mobility using the Timed Up and Go
Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
Full Information
NCT ID
NCT02754271
First Posted
April 21, 2016
Last Updated
April 25, 2016
Sponsor
Toronto Rehabilitation Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02754271
Brief Title
Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
Official Title
Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
A research-based film (Fit for Dialysis) and a 16-week exercise program involving activities during dialysis, at home, and in the community.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The 16-week exercise program involving activities during dialysis, at home, and in the community.
Intervention Type
Other
Intervention Name(s)
Fit for Dialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence measured by the percentage of time participants achieved at least 70% of prescribed targets of minutes and intensity of exercise per week.
Time Frame
1-16 weeks
Title
Change in functional exercise capacity measured by the 2-Minute Walk Test
Time Frame
0, 8, 16, 28 weeks
Secondary Outcome Measure Information:
Title
Change in number of steps using a pedometer
Time Frame
0, 8, 16, 28 weeks
Title
Change in basic mobility using the Timed Up and Go
Time Frame
0, 8, 16, 28 weeks
Title
Change in self-assessment of functional of capacities and peak metabolic equivalents using the Duke Activity Status Index
Time Frame
0, 8, 16, 28 weeks
Title
Change in upper extremity strength as a predictor of mortality and deteriorating health using the Grip Strength Test
Time Frame
0, 8, 16, 28 weeks
Title
Change in the frequency of mild, moderate, and strenuous bouts of exercise using the Godin Leisure-Time Exercise Questionnaire
Time Frame
1-16, 28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pia Kontos, PhD
Phone
416-597-3422
Ext
7609
Email
pia.kontos@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Romeo Colobong, MA
Phone
416-597-3422
Ext
7885
Email
romeo.colobong@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Kontos, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humber River Hospital - Wilson Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Joseph's Health Centre - Satellite Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8Z 6A4
Country
Canada
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30081845
Citation
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.
Results Reference
derived
PubMed Identifier
28122510
Citation
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.
Results Reference
derived
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Fit for Dialysis: Research-based Film as a Knowledge Translation Strategy
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