- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969512
Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) (HIPPER)
Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) Intervention Protocol: An eHealth Approach for Pre-surgical Hip Replacement Education
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 2G9
- GF Strong Rehabilitation Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: HIPPER
The HIPPER group will receive 12 interactive online modules (~20 minutes each).
HIPPER participants will receive email or phone contact (participant preference) to provide them with website portal access consisting of the web address, and simple instructions to access the website using personalized encrypted login information to the site.
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Participants can complete the online educational modules at home or another location with internet access.
The total time to complete all of the modules is about 2 hours and 30 minutes.
Other Names:
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Active Comparator: OASIS Online Educational Webinars
To provide a comparable level of education, participants in the Online Education group will receive 2 hours of OASIS online educational webinars as per current practice.
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2-hour online educational large group sessions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Hospital Anxiety and Depression Scale (HADS-A) measures anxiety symptoms.
The anxiety subscale (HADS-A) has 7 items, each rated 0-3 and summed to a total of 0-21.
Higher scores indicate worse outcomes (greater anxiety).
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Hospital Anxiety and Depression Scale (HADS-D) measures depression symptoms.
The depression subscale (HADS-D) has 7 items, each rated 0-3 and summed to a total of 0-21.
Higher scores indicate higher levels of depression.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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Oxford Hip Score (OHS)
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Oxford Hip Score (OHS) measures pain and function in patients with hip osteoarthritis.
It has 12 items, each rated 0-4, summed to a total of 0-48.
Higher scores indicate lower levels of disability.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Self-Efficacy for Rehabilitation Outcome Scale (SER) measures confidence in performing rehabilitation activities.
It has 12 items, each rated 0-10, summed to a total of 0-120.
Higher scores indicate greater self-efficacy.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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System Usability Scale (SUS)
Time Frame: T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery); Completed only by participants in the HIPPER group.
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The System Usability Scale (SUS) measures perceived usability of a system.
It has 10 items rated on a 5-point scale; item scores are converted, summed, and multiplied by 2.5 to give a total of 0-100.
Higher scores indicate better perceived usability.
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T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery); Completed only by participants in the HIPPER group.
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Hip Disability and Osteoarthritis Outcome Score - Activities of Daily Living Subscale (HOOS-ADL)
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities of Daily Living (ADL) subscale measures difficulty with daily activities in patients with hip osteoarthritis.
It has 17 items, each rated on a five-point Likert scale (0 = none to 4 = extreme difficulty), summed to a total ranging from 0 to 68.
Higher scores indicate greater difficulty with daily activities.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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Physical Activity Scale for the Elderly (PASE)
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Physical Activity Scale for the Elderly (PASE) measures self-reported physical activity over the past 7 days in older adults.
Scores are a weighted sum of time spent across activity types, ranging from 0 to 400 or more.
Higher scores indicate greater physical activity.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The EuroQol 5-Dimension 5-Level (EQ-5D-5L) measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Responses were converted to a single utility index ranging from -0.285 to 1 (extreme problems on all dimensions) to 1 (full health).
Higher scores indicate better health-related quality of life.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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Equipment Checklist
Time Frame: T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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The Equipment Checklist included recommended equipment and mobility aids for total hip replacement.
This checklist was developed in accordance with current guidelines and clinical recommendations.
Participants indicated which items they had obtained.
The reported value is the number of items obtained per participant.
Higher scores indicate more recommended equipment obtained.
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T1 (Baseline); T2 (7-10 days before surgery); T3 (Post-Intervention, 30 days after surgery)
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30-second Chair-Stand Test
Time Frame: T1 (Baseline); T2 (7-10 days before surgery).
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The 30-Second Chair-Stand Test measures lower-body strength and endurance.
Participants stand fully from a seated position and sit back down as many times as possible within 30 seconds.
The score is the number of completed sit-to-stand repetitions.
Higher scores indicate better lower-body strength and function.
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T1 (Baseline); T2 (7-10 days before surgery).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William C Miller, PhD, University of British Columbia
Publications and helpful links
General Publications
- Simpson, E., Mohammadi, S., Miller, W. C., Yu, N., Watson, W., Spillane, A., & Westby, M. D. (2022). Reliability of conducting the 30-second chair stand test virtually among individuals with osteoarthritis. Archives of Rheumatology & Arthritis Research, 2(4), Article ARAR.MS.ID.000542.
- Dhariwal A, Mohammadi S, Simpson E, Westby MD, Watson W, Miller WC. Patient-centered perspectives: A qualitative evaluation of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER). PLoS One. 2025 Apr 24;20(4):e0322114. doi: 10.1371/journal.pone.0322114. eCollection 2025.
- 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.
- Mohammadi S, Westby MD, Schneeberg A, Watson W, Dhariwal A, Simpson E, Miller WC. The hip instructional prehabilitation program for enhanced recovery (HIPPER) as an eHealth approach to presurgical hip replacement Education: Feasibility randomized controlled trial. Int J Orthop Trauma Nurs. 2025 Aug;58:101210. doi: 10.1016/j.ijotn.2025.101210. Epub 2025 Jun 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-02553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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