Face to Face or Digitally Delivered First-line Osteoarthritis Treatment?

NCT04836988 | Completed

• 1 other identifier: Observational
• Study Type: observational
• Target: 6,946
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare outcomes of two different delivery methods (Face-to-face and digitally) of first-line treatment for hip and knee osteoarthritis.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain assessed with the Numeric Rating Scale (NRS)

  The NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain.

  Change from baseline to three months

Secondary Outcomes (3)

• Walking difficulties

  Change from baseline to three months

• Willingness for surgery

  Change from baseline to three months

• Health-related quality of life

  Change from baseline to three months

Study Arms (2)

Digitally delivered osteoarthritis treatment

Participants enrolled in the digitally delivered osteoarthritis managament program (Joint Academy register)

Other: Three months of digitally delivered osteoarthritis treatment

Face-to-face delivered osteoarthritis treatment

Participants enrolled in the face-to-face delivered osteoarthritis managament program (BOA-register)

Other: Three months of face-to-face delivered osteoarthritis treatment

Interventions

Three months of digitally delivered osteoarthritis treatment OTHER

Digitally delivered osteoarthritis management including education and exercise and weight control if needed

Digitally delivered osteoarthritis treatment

Three months of face-to-face delivered osteoarthritis treatment OTHER

Face-toface delivered osteoarthritis management including education and exercise and weight control if needed

Face-to-face delivered osteoarthritis treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a clinical diagnosis of hip or knee osteoarthritis that have participated for three months in either digitally or face-to-face osteoarthritis management will be included

You may qualify if:

• A clinical diagnosis of hip or knee OA
• Participated for three months in any of the programs between 2018-04-01 and 2020- 03-31
• Reported pain at both baseline and at 3 months follow-up
• Adherence of ≥80%, i.e., ≥80% completed education videos, exercises and questionnaires offered in the digital program and participation in two out of three educational lessons and at least 10 of the 12 supervised group exercise sessions offered in the BOA.

You may not qualify if:

• None

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University

Lund, Skåne County, 22100, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anna Cronström

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: March 6, 2021
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: SAP is available at Lund University website: https://lucris.lub.lu.se/admin/editor/dk/atira/pure/modules/unifiedprojectmodel/external/model/project/editor/upmprojecteditor.xhtml?id=97180259

Locations

SE (1)