Clinical trial NCT02969512: Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER)
Official title: Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) Intervention Protocol: An eHealth Approach for Pre-surgical Hip Replacement Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Patient education
Advanced hip osteoarthritis
Online education
Computer-assisted instruction
e-learning
Older adult
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-11-21
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility impairment. Given the boom in the older demographic it is not surprising that there is an 11% increased demand for replacement every 5 years in Canada. Health promotion interventions, such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT) that will assess feasibility indicators and clinical outcomes of online prehab education modules compared to online educational webinars. The feasibility indicators (process, resource, management, and treatment issues) and clinical outcomes (physical function, anxiety, depression, pain, daily activities, self-efficacy, and health related quality of life) will be assessed among Vancouver-dwelling older adults aged \> 50 years, with advanced hip osteoarthritis. The findings will lead to the refinement of the design protocol in order to evaluate a contemporary, standardized, and geographically accessible prehab education program in a large multi-site RCT.

Detailed 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 consisting of 12 modules (\~20 mins/module). The control group is usual practice consisting of a 2 hr online large group educational webinar. Feasibility indicators (i.e. recruitment and retention; 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, daily activities, self-efficacy, equipment checklist, system usability scale, 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. 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), and 30 days post-surgery (T3).

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.

Eligibility criteria: Inclusion Criteria:

Community-dwelling participants with advanced hip OA will be included if they:

* are living in the greater Vancouver region;
* are aged 50 years or older;
* are scheduled to have a single THR in 12 weeks or later;
* have access to the internet

Exclusion Criteria:

* cannot communicate and complete questionnaires in English;
* anticipate a health condition or procedure that contraindicates their THR surgery;
* are actively receiving physical therapy for their hip symptoms;
* have had a previous THR.

Primary outcomes:
measure: Change in Primary Clinical Outcomes Scale
timeFrame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
Secondary outcomes:
measure: 30-second Chair-Stand Test
timeFrame: Baseline,7-10 days before surgery.
measure: Change in Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
measure: Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
timeFrame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
measure: Equipment Checklist
timeFrame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
measure: EuroQol-5 Dimension, 5 level
timeFrame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
measure: System Usability Scale
timeFrame: 7-10 days before surgery, Post Intervention (30 days after surgery)
measure: Oxford Hip Score (OHS)
timeFrame: Baseline, 7-10 days before surgery, Post Intervention (30 days after surgery)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller WC, Mohammadi S, Watson W, Crocker M, Westby M. The Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) as an eHealth Approach to Presurgical Hip Replacement Education: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 6;10(7):e29322. doi: 10.2196/29322.