Knee-hip Surgery Wait-list Support Program
NCT Number: NCT06575621
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Arthropathy|Hip Arthropathy
Interventions: BEHAVIORAL: Support program
Sponsor: Nova Scotia Health Authority
Collaborators: Acadia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-15
Completion Date: 2025-08-30

Summary:
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.

Primary Outcome Measures: Recruitment rate, the number of consenting participants divided by the total number of participants asked to join the study, Study baseline|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, Study baseline|Adherence to enhanced support program, percent of planned sessions attended, Pre-surgery (10-16 weeks after baseline)|Completion rate, number of participants that completed the study divided by the number of participants that started the study, Pre-surgery (10-16 weeks after baseline)
Secondary Outcome Measures: Condition specific health-related quality of life, Oxford hip/knee questionnaire, score range 12-60, lower scores are better, 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)|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, 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)|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, Study baseline and pre-surgery (10-16 weeks after baseline)|Physical activity level, Godin-Shepherd Leisure-Time Physical Activity Questionnaire (measures self-reported minutes of moderate to vigorous physical activity per week), Study baseline and pre-surgery (10-16 weeks after baseline)|Physical function, 30s sit to stand test (number of repetitions completed), 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)|Physical fitness, two-minute step test (number of steps completed), Study baseline and pre-surgery (10-16 weeks after baseline)|Hemoglobin A1c, blood test, Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline)|estimated glomerular filtration rate, blood test, Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline)|Hemoglobin, blood test, Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline)|Frailty, Frailty screen, score range 1-8, lower scores are better, Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline)|Body mass index, weight and height will be combined to report BMI in kg/m\^2, weight and height will be measured by research staff, Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline)|Blood pressure, measured by research staff, Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline)|Program satisfaction, program specific satisfaction survey, Pre-surgery (10-16 weeks after baseline)