Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hip Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

Description

This feasibility study will use a single-site, parallel group evaluator blind RCT. Subjects (N=40) will be randomly assigned to the experimental (HIPPER n=20) or control (n=20) groups.The experimental group will receive the interactive online HIPPER intervention consists of 10 modules (2 hrs/module)...

This feasibility study will use a single-site, parallel group evaluator blind RCT. Subjects (N=40) will be randomly assigned to the experimental (HIPPER n=20) or control (n=20) groups.The experimental group will receive the interactive online HIPPER intervention consists of 10 modules (2 hrs/module) supported by phone access to Trainers. The control group is usual practice consisting of 2 x 2 hr small group educational sessions. Feasibility indicators (i.e. recruitment and retention; trainer and subject burden; safety; intervention administration/adherence; perceived benefit) will be evaluated as binary outcomes against pre-set parameters reflecting viability for a multi-site large-scale RCT. The primary clinical outcome of interest when assessing effect size for the eventual RCT is the Hospital Anxiety and Depression Scale-Anxiety. Secondary clinical outcomes include measures of pain, function, self-efficacy, environmental setup, physical activity and health related quality of life. Upon successful screening/enrollment and baseline data collection (T1) the Study Coordinator will contact the statistician by telephone or email and obtain group assignment within 48 hours. Subjects will be randomized using a 1:1 allocation ratio between groups. A central computerized randomization process will be designed by the statistician, with an undisclosed block size. Subject contact information will be forwarded to the appropriate group Trainer. To address bias, subjects will be instructed not to discuss their program and Testers will reinforce this point at each session. T1 data will be collected at our clinic while the follow up data collected 7-10 days prior to surgery (T2), 30 (T3) and 90 days (T4) post-surgery. The findings from the study will be summarized and mailed to each participant upon study completion. HIPPER and control group assessments will be held at GF Strong Rehabilitation Centre and at subject's homes. The outcome will lead to the refinement of the design protocol in order to robustly evaluate a contemporary, standardized, and geographically accessible prehabilitation education program. Ultimately, HIPPER may be found to have significant individual and social (health system level) benefits.

Tracking Information

NCT #
NCT02969512
Collaborators
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: William C Miller, PhD University of British Columbia