Aim: To determine the feasibility of conducting a Randomized Control Trial (RCT) comparing a pre-operative multi-modal intervention for pre-frail/frail patients undergoing total hip replacement surgery compared to usual care. Secondary objectives include examining change in frailty (Fried Frailty Phenotype, GERAS Fit Frailty Index).
The cost-effectiveness of the proposed program will be evaluated alongside our pilot RCT. We will compare changes in quality-adjusted life years (QALYs), rates of hospitalization or re-admission and healthcare resource use (costs) over the period of 12 months in 62 eligible participants, randomly assigned to either multimodal frailty intervention or usual care.
Overview: The overall aim of our Fit‐Hips pilot randomized controlled trial (RCT) is to determine the feasibility of introducing preventive multi-modal strategies for pre-frail/frail seniors in regional joint assessment program (RJAP)- Hamilton Site, Ontario. This study will recruit 62 pre-frail or frail participants aged 65 years or older, planned for an elective unilateral total hip replacement at the HHS-Juravinski RJAP site. The multi-modal frailty intervention will consist of a tailored exercise program, combined with protein and vitamin D supplementation and medication review.
Outcomes – Primary feasibility outcomes include:
- Recruitment rate (targeting ≥ 70%)
- Retention rate (targeting ≥ 80%)
- Data collection (targeting ≥ 80% completeness)
- Adherence to all intervention components (targeting ≥ 80% completeness)
Additionally, this feasibility study will allow us to pilot clinical economic outcome measures.