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Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) (HIPPER)

Primary Purpose

Hip Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HIPPER
OASIS Online Educational Webinars
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hip Osteoarthritis focused on measuring Patient education, Advanced hip osteoarthritis, Online education, Computer-assisted instruction, e-learning, Older adult

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GF Strong Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIPPER

OASIS Online Educational Webinars

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Primary Clinical Outcomes Scale
Hospital Anxiety and Depression Scale (HADS-A): The HADS-A is a validated 7-item tool that includes tension, worry and fear and has respondents indicate how they currently feel on each item.

Secondary Outcome Measures

30-second Chair-Stand Test
Functional lower limb strength and dynamic balance will be assessed by having subjects perform repeated sit-to-stands using a standard 43-46 cm straight back chair with no arm rests.
Change in Physical Activity Scale for the Elderly (PASE)
Patients are less physically active prior to THR and show minimal improvements in activity levels post-operatively. PASE is 12-item tool developed for older adults to assess home, occupational and recreational activities in the previous 7 days.
Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
The SER is a 12-item questionnaire that asks patients to rate their confidence on an 11-point Likert scale and generates 2 subscale scores: self-efficacy for rehabilitation therapy exercises and self-efficacy for overcoming barriers.
Equipment Checklist
It is recommended that patients acquire equipment and mobility aids prior to THR to ensure their safety, carry out daily living activities and adhere to surgical precautions post-operatively. A comprehensive checklist of recommended equipment will be created based on current guidelines, clinical recommendations and our Patient Partners' input.
EuroQol-5 Dimension, 5 level
Health-related quality of life is a core outcome for hip OA and the EQ-5D a suggested measure. The EQ-5D is a brief questionnaire that assesses 5 health status domains, reflected in a single-score, and overall health state using a visual analogue scale.
System Usability Scale
System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from "Strongly agree" to "Strongly disagree". Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. Some example items are "I think that I would like to use this system frequently." and "I needed to learn a lot of things before I could get going with this system." In this study, we replaced "the system" with "Hipper" to capture the opinion of participants regarding the usability of our eHealth program
Oxford Hip Score (OHS)
The OHS is a 12-item tool that assesses pain and function in patients undergoing hip replacement surgery. It demonstrates good construct validity and test-retest reliability in THR

Full Information

First Posted
November 9, 2016
Last Updated
May 16, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02969512
Brief Title
Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER)
Acronym
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Patient education, Advanced hip osteoarthritis, Online education, Computer-assisted instruction, e-learning, Older adult

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIPPER
Arm Type
Experimental
Arm Description
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.
Arm Title
OASIS Online Educational Webinars
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HIPPER
Other Intervention Name(s)
Behavioral: Online prehab education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
OASIS Online Educational Webinars
Other Intervention Name(s)
Behavioral: large group education sessions
Intervention Description
2-hour online educational large group sessions
Primary Outcome Measure Information:
Title
Change in Primary Clinical Outcomes Scale
Description
Hospital Anxiety and Depression Scale (HADS-A): The HADS-A is a validated 7-item tool that includes tension, worry and fear and has respondents indicate how they currently feel on each item.
Time Frame
Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
Secondary Outcome Measure Information:
Title
30-second Chair-Stand Test
Description
Functional lower limb strength and dynamic balance will be assessed by having subjects perform repeated sit-to-stands using a standard 43-46 cm straight back chair with no arm rests.
Time Frame
Baseline,7-10 days before surgery.
Title
Change in Physical Activity Scale for the Elderly (PASE)
Description
Patients are less physically active prior to THR and show minimal improvements in activity levels post-operatively. PASE is 12-item tool developed for older adults to assess home, occupational and recreational activities in the previous 7 days.
Time Frame
Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
Title
Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
Description
The SER is a 12-item questionnaire that asks patients to rate their confidence on an 11-point Likert scale and generates 2 subscale scores: self-efficacy for rehabilitation therapy exercises and self-efficacy for overcoming barriers.
Time Frame
Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
Title
Equipment Checklist
Description
It is recommended that patients acquire equipment and mobility aids prior to THR to ensure their safety, carry out daily living activities and adhere to surgical precautions post-operatively. A comprehensive checklist of recommended equipment will be created based on current guidelines, clinical recommendations and our Patient Partners' input.
Time Frame
Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
Title
EuroQol-5 Dimension, 5 level
Description
Health-related quality of life is a core outcome for hip OA and the EQ-5D a suggested measure. The EQ-5D is a brief questionnaire that assesses 5 health status domains, reflected in a single-score, and overall health state using a visual analogue scale.
Time Frame
Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
Title
System Usability Scale
Description
System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from "Strongly agree" to "Strongly disagree". Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. Some example items are "I think that I would like to use this system frequently." and "I needed to learn a lot of things before I could get going with this system." In this study, we replaced "the system" with "Hipper" to capture the opinion of participants regarding the usability of our eHealth program
Time Frame
7-10 days before surgery, Post Intervention (30 days after surgery)
Title
Oxford Hip Score (OHS)
Description
The OHS is a 12-item tool that assesses pain and function in patients undergoing hip replacement surgery. It demonstrates good construct validity and test-retest reliability in THR
Time Frame
Baseline, 7-10 days before surgery, Post Intervention (30 days after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Somayyeh Mohammadi, PhD
Phone
604-714-4108
Email
somayyeh.mohammadi@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C Miller, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William C Miller, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34255722
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. Erratum In: JMIR Res Protoc. 2022 Jul 14;11(7):e39745.
Results Reference
derived

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Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER)

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