Effects of a Structured Digital Osteoarthritis Self-management Program After 6 Months of Adherence

August 7, 2019 updated by: Lund University
This is a study based on a cohort in a register of patients enrolled in a digital osteoarthritis self-management program, Joint Academy. The purpose of this study is to examine joint pain and the potential change of this pain, in patients with long-term adherence to a digital self-management program for individuals with knee- and hip osteoarthritis. The hypothesis, based on preliminary findings is that pain levels of those adhering to the program, decreases over time. To test the hypothesis, participants weekly pain report will be investigated whilst adhering to the digital program for 6- to 12 months, and statistically tests will be performed to find out whether significant differences can be seen over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Osteoarthritis (OA) is highly prevalent in older adults and a growing cause of disability. The importance of availability of primary treatment of OA is gaining momentum, and web-based self-management programs have in recent years become available. Evidence of short term effects of such programs are abundant, yet the evaluation of long term effects of these programs is scarce.

Aim To investigate joint pain development over time from participation in a web-based OA self-management program for people with hip or knee OA.

Methods Participants joined the program through advertisements and campaigns on the web. Included participants had a radiographic or clinical diagnosis of hip or knee OA (about 95%) from a physical therapist or physician. The intervention consisted of a digital, structured and individualized treatment program for people with hip or knee OA (Joint Academy®; www.jointacademy.com). The program consists of neuromuscular exercises appropriately adjusted to each patient in regard to degrees of complexity and difficulty and information in the form of text or video lessons (with quizzes on the material after each episode) on subjects related to OA, OA symptoms and its management.

Outcome measures Joint pain in the hip or knee was assessed at baseline, and weeks 12, 24 and 48 using the Numerical Rating Scale (NRS), a 0-10 scale where 0 is defined as No pain and 10 is defined as Maximum pain. Minimal clinically important change (MCIC) of pain was defined as an improvement of 20%. As a measure of physical function, the 30-second chair stand test (30CST) was used and performed by the patient every other week, using an instruction video with a coupled visual timer. The patient entered the performed number of repetitions after each test. Physical function data was handled similarly to the NRS, with week 24 ±4 adjacent weeks and week 48±6 adjacent weeks included for those with available NRS data. All outcomes were self-assessed, self-centred, and chosen based on the International Consortium for Health Outcomes Measurement Standard Set for Hip & Knee Osteoarthritis (ICHOM).

Statistical analysis Summary data are described by the mean value, standard deviation and number of observations or the number and percent of the categories of interest. The group-specific mean treatment effect of duration on pain and repetitions (30CST - physical function), as well as differences in pain over time between hip and knee OA with or without additional covariates, were estimated and tested using random slopes and intercepts models. Pain development over time was plotted for hip and knee OA respectively.

To describe patients adhering for six months with contrasting pain severity at baseline, participants were divided into same-sized tertiles based on reported baseline pain, with related descriptive data. Mean pain per time point was calculated and plotted for each group. Significance level was set to p<0.05, and p-values and 95% confidence intervals were reported when applicable. Statistical calculations were performed in Statistical Package for Social Sciences (SPSS Version 25, IBM Corporation, New York, USA) and Stata 15.1 (StataCorp LLC, Texas, USA).

Study Type

Observational

Enrollment (Actual)

1709

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Arthro Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

At the time of the study start (13th of March, 2019), the Joint Academy patient database contained data from 1709 Swedish participants who had reported one of their knees or hips as their most symptomatic joint

Description

Inclusion Criteria:

  • radiographic or clinical diagnosis of hip or knee OA (about 95%) from a physical therapist or physician
  • had been treated in the digital non-surgical treatment program the first 3 weeks with a adherence of at least 70%
  • had been included in the program at least 24 weeks prior to the data extraction

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
24 weeks
Subjects who participated in the intervention who have data available at week 24
Other: Education+ exercise (delivered digitally)
The intervention consisted of a digital, structured and individualized treatment program for people with hip or knee OA (Joint Academy®; www.jointacademy.com). The program consists of neuromuscular exercises appropriately adjusted to each patient in regard to degrees of complexity and difficulty, continuous access to and dialogue with a physiotherapist through a chat function, and/or telephone , and information in the form of text or video lessons (with quizzes on the material after each episode) on subjects related to OA, OA symptoms and its management.
48 weeks
Subjects who participated in the intervention who have data available at week 48
Other: Education+ exercise (delivered digitally)
The intervention consisted of a digital, structured and individualized treatment program for people with hip or knee OA (Joint Academy®; www.jointacademy.com). The program consists of neuromuscular exercises appropriately adjusted to each patient in regard to degrees of complexity and difficulty, continuous access to and dialogue with a physiotherapist through a chat function, and/or telephone , and information in the form of text or video lessons (with quizzes on the material after each episode) on subjects related to OA, OA symptoms and its management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NRS pain
Time Frame: 0-24 and 0-48 weeks
0 no pain, 10 max pain
0-24 and 0-48 weeks
Change in 30 second chair stand test (30CST)
Time Frame: 0-24 and 0-48 weeks
sit to stand repetitions in 30 seconds
0-24 and 0-48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Håkan Nero, PhD, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2019

Primary Completion (Actual)

March 14, 2019

Study Completion (Actual)

March 14, 2019

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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