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Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis

Primary Purpose

Osteoarthritis, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Online training program in weight management for osteoarthritis
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Currently registered with the Australian Health Practitioner Registry
  • Have access to a computer with internet connection
  • Willing to commit to completion of an 8-10 hour online training module if randomized to the intervention group
  • Willing to refrain from participating in any weight management professional development activity external to the study for six weeks of intervention
  • Able to give informed consent and to commit and participate fully in the assessment and evaluation procedures over the six week period.

Exclusion Criteria:

  • n/a

Sites / Locations

  • University of Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

online training program

control group

Arm Description

online training program Participants receive access to online training program consisting of 6 e-learning modules on topics of weight management in osteoarthritis, which they will be instructed to and encourage to complete over the 6 intervention period.

control group Participants do NOT receive access to the online training program consisting of 6 e-learning modules on topics of weight management in osteoarthritis during the intervention period.

Outcomes

Primary Outcome Measures

Self-reported confidence in knowledge about weight management for patients with osteoarthritis
Measured using an expert-developed, customized self-reported questionnaire exploring physiotherapists' perceived confidence in knowledge about weight management in osteoarthritis. Total score out of 70 possible points calculated from the responses to 14 Likert Scale (1-5) questions where higher values indicate higher confidence and lower values lower confidence in knowledge

Secondary Outcome Measures

Self-reported confidence in clinical skills for weight management for patients with osteoarthritis
Measured using an expert-developed, customized self-reported questionnaire exploring physiotherapists' perceived confidence in clinical skills for weight management in osteoarthritis. Total score out of 45 possible points calculated from the responses to 9 Likert Scale (1-5) questions where higher values indicate higher confidence and lower values lower confidence in clinical skills.
Self-perceived competence in nutrition care to patients with chronic disease
Measured using the NUTCOMP Questionnaire, a validated six section questionnaire (four sections scored, two unscored) developed to explore health care professional's perceived competence of the provision of nutrition care. Total score out of 175 possible points calculated from the responses to the Likert Scale (1-5) for each of the 35 questions, where higher values indicate higher confidence and lower values, lower confidence.
Weight stigmatized attitudes
Measured by the Anti-Fat Attitudes questionnaire which comprises 13 statements about beliefs about weight (categorized under Dislike, Fear and Willpower) which respondents answer on a 10 point 0-9 Likert type scale, where 0 = very strongly disagree and 9 = very strongly agree. Total score calculated by response to each statement out of eight. The 3 subscales (dislike, fear and willpower) will also be reported.

Full Information

First Posted
September 22, 2020
Last Updated
July 7, 2021
Sponsor
University of Melbourne
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04574804
Brief Title
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
Official Title
Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

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

5. Study Description

Brief Summary
A randomized controlled trial for which the primary objective is to evaluate the effects of an online training program on physiotherapist's self-reported confidence in knowledge about weight management for people with osteoarthritis. 80 physiotherapists will be recruited into the study and randomized to one of two arms a) online training program (access to training program for 6 weeks) or b) control group (no access to online training program during the study). Questionnaires will be completed by all participants at baseline, and again at the end of the 6 week intervention period. A biostatistician will analyse blinded, de-identified data.
Detailed Description
The Centre for Health Exercise and Sports Medicine at the University of Melbourne have developed a 6-module online training program designed to up-skill physiotherapists in weight management for osteoarthritis patients. This is a randomised controlled trial evaluating the effectiveness of the training program on physiotherapist's confidence in weight management for osteoarthritis patients. After providing informed consent and baseline data, physiotherapists will be randomized to either a) an online training program or b) control group. Those randomized to the online training group will be provided access to the a 6-module weight management training program and have six weeks to complete all the modules. Those randomized to the control group will receive no intervention. At baseline and six weeks, primary and secondary outcome measures will be completed in both groups. The research question is: What are the effects of an online training program designed to up-skill physiotherapists in weight management for people with osteoarthritis? The primary objective is to evaluate the effects of an online training program on physiotherapist's self-reported confidence in knowledge about weight management for people with osteoarthritis. 80 participants will be recruited and randomization into the two study groups. To detect an effect size of 0.8 with 80% power and two sided significance level of 5%, 26 participants are required per group. Assuming a 35% loss to follow up, this will increase the same size to 40 per group (80 in total). The study will be conducted through The University of Melbourne. Participants will be able to access the training remotely in their own time and access all outcome measures online. A biostatistician will analyse blinded, de-identified data. Analyses will be conducted with participants in assigned groups, with multiple imputation to account for missing data if required. Changes in self-reported confidence scores (primary outcome) will be compared between groups at 6 weeks using linear regression (with group as a factor) adjusting for baseline scores and the stratifying variables. Similar analyses will be conducted for secondary outcomes measured at baseline and 6 weeks. Process measures will be described in terms of mean (SD)/median (IQ range) or number (frequency). Standard diagnostic plots will be used to verify model assumptions. If an imbalance is noted between groups for relevant baseline characteristics, sensitivity analyses will be conducted including these characteristics as covariates in the models assessing treatment effects. The biostatistician will also conduct planned exploratory analyses to investigate potential moderators that could influence the effect of the training at 6 weeks. Pre-identified potential moderators include practice location (predominantly private vs predominantly public), baseline self rated confidence in weight management and years of clinical experience. To assess the moderation of the effect of randomised treatment group by the binary potential moderator (practice location), an interaction term between randomised group and the potential moderator, as well as terms for the randomised group and the potential moderator, will be included in the outcome regression model. To assess the moderation of the effect of randomised treatment group by continuous potential moderators (self rated confidence in weight management and years of clinical experience), the multivariable fractional polynomial interaction approach will be applied. This approach allows for nonlinear functional forms of the continuous potential moderator to be included in the regression model for outcomes, with the potential for separate nonlinear functional forms in each treatment group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Overweight and Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Randomisation of participants will be conducted by a researcher with no direct involvement in the study. The biostatistician will analyse blinded, de-identified data.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
online training program
Arm Type
Experimental
Arm Description
online training program Participants receive access to online training program consisting of 6 e-learning modules on topics of weight management in osteoarthritis, which they will be instructed to and encourage to complete over the 6 intervention period.
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group Participants do NOT receive access to the online training program consisting of 6 e-learning modules on topics of weight management in osteoarthritis during the intervention period.
Intervention Type
Other
Intervention Name(s)
Online training program in weight management for osteoarthritis
Intervention Description
An evidence based online education training program for physiotherapists in weight management for osteoarthritis. Training modules cover the following topic areas: Overweight and obesity and osteoarthritis Overview of weight regulation, overweight and obesity Examining weight stigma in physiotherapy and personal beliefs about weight Communication approach for addressing weight management Interventions for weight management Health behaviour change support These 6 e-learning modules comprise the online training program, access to which comprises the study intervention.
Primary Outcome Measure Information:
Title
Self-reported confidence in knowledge about weight management for patients with osteoarthritis
Description
Measured using an expert-developed, customized self-reported questionnaire exploring physiotherapists' perceived confidence in knowledge about weight management in osteoarthritis. Total score out of 70 possible points calculated from the responses to 14 Likert Scale (1-5) questions where higher values indicate higher confidence and lower values lower confidence in knowledge
Time Frame
Change from baseline at 6 weeks post randomization
Secondary Outcome Measure Information:
Title
Self-reported confidence in clinical skills for weight management for patients with osteoarthritis
Description
Measured using an expert-developed, customized self-reported questionnaire exploring physiotherapists' perceived confidence in clinical skills for weight management in osteoarthritis. Total score out of 45 possible points calculated from the responses to 9 Likert Scale (1-5) questions where higher values indicate higher confidence and lower values lower confidence in clinical skills.
Time Frame
Change from baseline at 6 weeks post randomization
Title
Self-perceived competence in nutrition care to patients with chronic disease
Description
Measured using the NUTCOMP Questionnaire, a validated six section questionnaire (four sections scored, two unscored) developed to explore health care professional's perceived competence of the provision of nutrition care. Total score out of 175 possible points calculated from the responses to the Likert Scale (1-5) for each of the 35 questions, where higher values indicate higher confidence and lower values, lower confidence.
Time Frame
Change from baseline at 6 weeks post randomization
Title
Weight stigmatized attitudes
Description
Measured by the Anti-Fat Attitudes questionnaire which comprises 13 statements about beliefs about weight (categorized under Dislike, Fear and Willpower) which respondents answer on a 10 point 0-9 Likert type scale, where 0 = very strongly disagree and 9 = very strongly agree. Total score calculated by response to each statement out of eight. The 3 subscales (dislike, fear and willpower) will also be reported.
Time Frame
Change from baseline at 6 weeks post randomization
Other Pre-specified Outcome Measures:
Title
Completion of training modules (process measure)
Description
Data will be collected through the learning management system platform. Completion of module will be categorized by passing end of module quiz with 100%. (Repeat attempts allowed). Number of modules completed reported.
Time Frame
Throughout 6 week intervention period
Title
Usefulness of modules (process measure)
Description
Self-reported using bespoke 4-item questionnaire upon completion of each module. Measured using a 5-point Likert scale from 1= strongly disagree to 5 = strongly agree. Items scored individually, higher scores for each item represent positive impressions towards training
Time Frame
Throughout 6 week intervention period
Title
Structure and content of modules (process measure)
Description
Impressions of module length and module content self reported using two custom questions, each assessed as one of 3 multi-choice options. Results for each multichoice option presented as a percentage for the 2 custom questions
Time Frame
Throughout 6 week intervention period
Title
Time to complete each module (process measure)
Description
Self-reported upon completion of each individual module (built into module quiz). Reported in minutes
Time Frame
Throughout 6 week intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Currently registered with the Australian Health Practitioner Registry Have access to a computer with internet connection Willing to commit to completion of an 8-10 hour online training module if randomized to the intervention group Willing to refrain from participating in any weight management professional development activity external to the study for six weeks of intervention Able to give informed consent and to commit and participate fully in the assessment and evaluation procedures over the six week period. Exclusion Criteria: n/a
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Bennell, PhD, BAppSci
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

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Effects of an Online Training Program for Physiotherapists About Weight Management for People With Osteoarthritis

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