Online Self-management in Hand Osteoarthritis

NCT05872633 | Completed DMC

• 1 other identifier: P15.379
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

NB. This study has been previously registered with the National Trial Registry (NTR6266) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov. The goal of this clinical trial is to study the effectiveness of an online self-management intervention in adult patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period. An RCT will be performed, in which 70 participants will be randomized to either care-as-usual (hand osteoarthritis care path, including consultation with the rheumatologist and a 1,5-hour consultation with a clinical nurse or occupational therapist, n=35) or care-as-usual plus the online self-management intervention (n=35). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention will be measured, by assessing productivity loss and health care use of participants (using iPCQ and iMCQ).

Conditions

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

Keywords

internet-based cognitive-behavioral therapy; cognitive-behavioral therapy; web-based; self-management; hand osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in pain coping

  A visual analogue scale (VAS) from 0 to 10 will be used to assess pain coping, with higher scores indicating better pain coping. The primary endpoint is the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention (immediately after the intervention).

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

Secondary Outcomes (9)

• Change in well-being

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in illness cognitions

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in pain coping strategies

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in illness perceptions

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

• Change in pain

  Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.

Other Outcomes (5)

• Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L)

  Baseline, immediately after the intervention, at 3 months follow-up.

• Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ)

  Baseline, immediately after the intervention, at 3 months follow-up.

• Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ)

  Baseline, immediately after the intervention, at 3 months follow-up.

Study Arms (2)

Online self-management intervention (and care-as-usual)

EXPERIMENTAL

At the start of the treatment, a face-to-face introductory meeting takes place between the participant and a psychologist, for acquaintance and to formulate goals for the treatment. Subsequently, a tailored self-management intervention, based on cognitive-behavioral therapeutic methods will be offered via an online program. Treatment will be conducted by a therapist who is specifically trained in the tailored cognitive-behavioral protocol. After finishing the online program, patients will be approached by their treating psychologist for two booster sessions via telephone. In these booster sessions it will be evaluated how the patient further attained his/her pre-set goals for the intervention. Strategies to strengthen the achieved results will be discussed. The booster sessions will take place 1 month and 2,5 months after finishing the online program.

Behavioral: Online self-management intervention

Care-as-usual

OTHER

Care-as-usual encompasses a consultation with the rheumatologist and a 1,5-hour consultation with a clinical nurse or occupational therapist of the Leiden University Medical Center. During this consultation, patients receive information on the nature of osteoarthritis, the prognosis, and available treatment modalities, and education on chronic pain, joint protection, healthy life style, and assistive devices.

Other: Care-as-usual

Interventions

Online self-management intervention BEHAVIORAL

Online self-management intervention (and care-as-usual)

Care-as-usual OTHER

Care-as-usual

Eligibility Criteria

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

You may qualify if:

• Diagnosed with hand osteoarthritis, following American College of Rheumatology (ARC) criteria (Altman et al., 1990)
• Referred to the hand osteoarthritis care path
• Complaints from hand osteoarthritis including pain, with a minimal duration of 3 months
• Minimum age of 18 years
• Fluent in Dutch language
• Able to give informed consent
• Own a computer with internet access

You may not qualify if:

• Difficulties with (written) communication (e.g., due to analphabetism) and lack of internet literacy
• Severe psychiatric comorbidities that interfere with the study protocol
• On-going psychological treatment elsewhere
• Patients with secondary osteoarthritis due to diseases, such as 1) inflammatory rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, etc., 2) bone diseases, such as M. Paget, osteochondritis, 3) metabolic diseases associated with joint disease, such as hemochromatosis, acromegaly, 4) severe crystal arthropathies, such as tophaceous polyarticular gout.

Sponsors & Collaborators

• Leiden University: lead
• Leiden University Medical Center: collaborator

Related Publications (1)

• Terpstra JA, van Beugen S, van der Vaart R, van Eersel RA, Dusseldorp E, Kloppenburg M, Evers AWM. An internet-based cognitive-behavioral self-management intervention for patients with hand osteoarthritis or fibromyalgia - Two randomized controlled trials. Internet Interv. 2026 Jan 19;43:100908. doi: 10.1016/j.invent.2026.100908. eCollection 2026 Mar.

  PMID: 41631249 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Evers, PhD

  Leiden University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and practitioners is not possible due to the nature of the study. However, the statistician who creates the randomization schedule and performs statistical analyses is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 24, 2023
• Study Start: August 1, 2016
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: IPD will become available once an article on the study is published on DataverseNL; the statistical analysis plan will be published on ClinicalTrials.gov during registration (before data analysis takes place).
• Access Criteria: Open access.