Knee-hip Surgery Wait-list Support Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this trial
This project will outline a pre-surgery support program that identifies risk factors related to poor surgical outcomes and recommends actions to improve these before surgery.
The main questions this study attempts to answer are:
1. Is a formalized knee-hip pre-surgery support program feasible, measured by recruitment rate, adherence, and completion rate? 2. Does the support program improve surgical risk factors including hemoglobin A1c (HB A1C), blood pressure, hemoglobin, estimated glomerular filtration rate (eGFR), frailty score, and physical fitness and function (measured with the 2-minute step test and 30s second sit to stand test)?
Participants will participate in education, medical navigation, and exercise.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
On surgery wait list for total hip or knee arthroplasty at Valley Regional Hospital
18+ and able to provide informed consent
Anticipated surgery time 8-16 weeks after the study start date
Disqualifiers
Any contraindications or exclusions identified through the assessment process that are outside thresholds for acceptable surgery risk
Trial design
Design model
Parallel
Treatments tested in this trial
Support program
Behavioraleducation, medical navigation, exercise
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Healthy controlNo intervention 0 interventions
Group C: Unhealthy controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
the number of consenting participants divided by the total number of participants asked to join the study
Time frame
Study baseline2
Recruitment rate for enhanced support
the number of consented and screened participants signing up to the support program, divided by the total number of participants recommended to the support program
Time frame
Study baseline3
Adherence to enhanced support program
percent of planned sessions attended
Time frame
Pre-surgery (10-16 weeks after baseline)4
Completion rate
number of participants that completed the study divided by the number of participants that started the study
Time frame
Pre-surgery (10-16 weeks after baseline)Secondary outcomes
1
Condition specific health-related quality of life
Oxford hip/knee questionnaire, score range 12-60, lower scores are better
Time frame
Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery)2
Generic health-related quality of life
Euroqol 5 dimension questionnaire 5 level version (EQ-5D-5L), used to calculate health utility scores which range from 0-1, higher scores are better
Time frame
Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery)3
Health behaviours
Health behaviours questionnaire (includes questions about drinking status, number of drinks consumed per week, smoking status, and number of cigarettes smoked per day
Time frame
Study baseline and pre-surgery (10-16 weeks after baseline)4
Physical activity level
Godin-Shepherd Leisure-Time Physical Activity Questionnaire (measures self-reported minutes of moderate to vigorous physical activity per week)
Time frame
Study baseline and pre-surgery (10-16 weeks after baseline)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Acadia University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: