OsteoarthritisNCT05872633
Online Self-management in Hand Osteoarthritis
A study testing Online self-management intervention and Care-as-usual in people with Osteoarthritis and Musculoskeletal Diseases, run by Leiden University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Musculoskeletal Diseases, Rheumatic Diseases
- What is being tested?
- Online self-management intervention and Care-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 19 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: An Online Self-management Intervention for Patients With Hand Osteoarthritis - a Randomized Controlled Trial
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).
Read the detailed description
Rationale: Hand osteoarthritis has a high clinical burden, as reflected by considerable pain, decreased strength and mobility, physical disability, and an often-decreased health-related quality of life. Self-management factors related to physical and psychosocial adjustment, such as patients' perceptions about their disease and coping, play an important role in heath-related quality of life and functional ability in patients with chronic diseases, such as osteoarthritis. Improving capacities of patients in managing a chronic condition is increasingly recognized as important in the treatment of (somatic) conditions and is becoming more common in clinical practice and research. In this study, the effect of an online self-management intervention focusing on coping skills related to chronic pain in comparison to care-as-usual is studied.
Objective: To study the effectiveness of the online self-management intervention in patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period.
Study design: 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). Baseline, post-intervention, 6-week, and three-month follow-up questionnaires will be used to measure primary and secondary outcomes. To assess implementation possibilities of the online intervention, structured qualitative interviews among patients and health professionals will examine to what extent the intervention suits the needs and skills of patients and to what extent the intervention fits within the current care process.
Study population: All patients ≥18 years with hand osteoarthritis who are referred to the hand osteoarthritis care path at the rheumatology clinic at Leiden University Medical Center with on-going pain complaints during at least three months will be invited to participate in the study. Patients need to be fluent in Dutch, need to be able to give informed consent, and have internet access. Severe psychiatric co-morbidity, on-going psychological treatment elsewhere, difficulties with (written) communication, a lack of internet literacy, and having secondary osteoarthritis are exclusion criteria.
Intervention: The intervention is based on cognitive-behavioral methods. It starts off with a face-to-face introduction consultation. Subsequently, the tailored self- management intervention will be offered via an online program. The intervention consists of six modules containing pain education, practical assignments, relaxation training, and registrations. The first and last modules are an introductory and closure module; in between are four modules aimed at learning how to cope with the consequences of a chronic condition in daily life. The modules focus on (1) activity, (2) mood, (3) thoughts, and (4) the social environment. At least once a week, participants receive feedback on the assignments and motivational support from a psychologist, by means of text messages in a secured mail box in the online program. 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.
Main study parameters/endpoints: 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).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the control group the usual standard of care is provided. In the intervention group patients will be offered an internet-based self-management intervention, which potentially improves their pain coping and other psychological and physical outcomes. No risk is involved with participation in this study. The only burden for participants is investment of time.
- Being tested
- Online self-management intervention, Care-as-usual
- Keywords
- internet-based cognitive-behavioral therapy, cognitive-behavioral therapy, web-based, self-management, hand osteoarthritis
- Medical subject headings
- Osteoarthritis, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-management interventionBehavioural
Care-as-usualOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Secondary outcomes (9)
Change in well-being
A VAS from 0 to 10 will be used to assess well-being, with higher scores indicating better well-being.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in illness cognitions
Illness cognitions will be measured by the Illness Cognition Questionnaire (ICQ) (specifically, Helplessness and Acceptance scales). Items are scored on a 4-point Likert scale ranging from "not at all" to "completely". Higher scale scores indicate greater use of the measured construct.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain coping strategies
Pain coping strategies will be measured by the Pain Coping Inventory (PCI). The questionnaire consists of six scales; Pain Transformation, Distraction, and Reducing Demands are characterized as active pain coping strategies, and Retreating, Worrying, and Resting are classified as passive pain coping strategies. Items are scored on a 4-point Likert scale ranging from "hardly ever" to "very often", with higher scale scores indicate greater use of the measured coping strategy.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in illness perceptions
Illness perceptions will be measured by the Illness Perception Questionnaire (IPQ-R). The Identity scale consists of the sum of yes-rated items (whether patients believe certain symptoms to be related to their illness). Furthermore, the Timeline Acute/Chronic, Timeline Cyclical, Consequences, Illness Coherence, Personal Control, Treatment Control, and Emotional Representations scales are rated on a 5-point Likert type scale ranging from "strongly disagree" to "strongly agree". High scores on the Identity, Timeline Acute/Chronic and Cyclical, Consequences, and Emotional Representations scales reflect beliefs about the number of symptoms attributed to the illness, the chronicity and cyclical nature, and the negative consequences of the illness, and patients' emotional experience of their illness. High scores on the Personal and Treatment Control and Coherence scales reflect positive beliefs about perceived control and an understanding of the illness.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain
A VAS from 0 to 10 will be used to assess pain, with higher scores indicating more severe pain.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain and disability
The Pain and Disability scales will be used of the Australian/Canadian Hand Osteoarthritis Index (AUSCAN). Items are rated on 5-point Likert scale ranging from "none" to "extreme", with higher scores indicating more pain and disability.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress
Part 1 of the Multidimensional Pain Inventory-Dutch Language Version (MPI-DLV) will be used, with the scales Interference and Pain Severity, and as exploratory measures Support, Life Control, and Affective Distress. Items are rated on various 7-point Likert scales, with higher scores indicating greater intensity in a subscale.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in health-related quality of life
Health-related quality of life will be measured by the RAND-36, which comprises 36 items that are averaged together to provide eight health scale scores, namely Physical Functioning, Role Limitations due to Physical Health Problems, Role Limitations due to Personal or Emotional Problems, Social Functioning, Emotional Well-being, Energy/Fatigue, Bodily Pain, and General Health Perceptions. It also includes one item on perceived change in health. Moreover, physical and mental health composite scores will be calculated. Higher scores indicate more advantageous health states.
Measured: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in health-related quality of life
Health-related quality of life will be measured by the the Five-Level Version of the EQ-5D (EQ-5D-5L). Five dimensions are assessed in 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A 5-point Likert scale ranging from "no problems" to "extreme problems" is applied, with higher scores corresponding with more problems in a HR-QoL dimension. Moreover, a VAS from 0 to 100 (0 = "The best health you can imagine" to 100 = "The worst health you can imagine") is used, with higher scores indicating a better perceived health state.
Measured: Baseline, immediately after the intervention, at 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Aug 2016
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Andrea W.M Evers, PhD, Leiden University
- Investigators
- Andrea Evers, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872633
- Sponsor's protocol ID
- P15.379
- Status last verified
- May 2023
- First submitted
- 30 Mar 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once an article on the study is published, a publication package will be published on DataverseNL. This package includes the manuscript, procedures, raw data files, computer code, and processed data files.
Publications
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.
PubMed 41631249
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Self-management Intervention for Patients With Hand Osteoarthritis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05872633
- Acronym / sponsor ID
- P15.379
- Keywords
- internet-based cognitive-behavioral therapy, cognitive-behavioral therapy, web-based, self-management, hand osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Rationale: Hand osteoarthritis has a high clinical burden, as reflected by considerable pain, decreased strength and mobility, physical disability, and an often-decreased health-related quality of life. Self-management factors related to physical and psychosocial adjustment, such as patients' perceptions about their disease and coping, play an important role in heath-related quality of life and functional ability in patients with chronic diseases, such as osteoarthritis. Improving capacities of patients in managing a chronic condition is increasingly recognized as important in the treatment of (somatic) conditions and is becoming more common in clinical practice and research. In this study, the effect of an online self-management intervention focusing on coping skills related to chronic pain in comparison to care-as-usual is studied.
Objective: To study the effectiveness of the online self-management intervention in patients with hand osteoarthritis and to explore the possibilities to implement the intervention in clinical practice after the study period.
Study design: 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). Baseline, post-intervention, 6-week, and three-month follow-up questionnaires will be used to measure primary and secondary outcomes. To assess implementation possibilities of the online intervention, structured qualitative interviews among patients and health professionals will examine to what extent the intervention suits the needs and skills of patients and to what extent the intervention fits within the current care process.
Study population: All patients ≥18 years with hand osteoarthritis who are referred to the hand osteoarthritis care path at the rheumatology clinic at Leiden University Medical Center with on-going pain complaints during at least three months will be invited to participate in the study. Patients need to be fluent in Dutch, need to be able to give informed consent, and have internet access. Severe psychiatric co-morbidity, on-going psychological treatment elsewhere, difficulties with (written) communication, a lack of internet literacy, and having secondary osteoarthritis are exclusion criteria.
Intervention: The intervention is based on cognitive-behavioral methods. It starts off with a face-to-face introduction consultation. Subsequently, the tailored self- management intervention will be offered via an online program. The intervention consists of six modules containing pain education, practical assignments, relaxation training, and registrations. The first and last modules are an introductory and closure module; in between are four modules aimed at learning how to cope with the consequences of a chronic condition in daily life. The modules focus on (1) activity, (2) mood, (3) thoughts, and (4) the social environment. At least once a week, participants receive feedback on the assignments and motivational support from a psychologist, by means of text messages in a secured mail box in the online program. 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.
Main study parameters/endpoints: 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).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the control group the usual standard of care is provided. In the intervention group patients will be offered an internet-based self-management intervention, which potentially improves their pain coping and other psychological and physical outcomes. No risk is involved with participation in this study. The only burden for participants is investment of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online self-management intervention (and care-as-usual) | Experimental | Behavioral: Online self-management interventionAt 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. |
| Care-as-usual | Other | Other: Care-as-usualCare-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-management intervention | Behavioural | Online self-management intervention (and care-as-usual) |
| Care-as-usual | Other | Care-as-usual |
Primary outcome
Change in pain coping
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
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).
9 secondary outcomes
Change in well-being
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in illness cognitions
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain coping strategies
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in illness perceptions
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain and disability
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in health-related quality of life
Time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.
Change in health-related quality of life
Time frame: Baseline, immediately after the intervention, at 3 months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 41631249Terpstra 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.
- Individual participant dataSharing planned: Yes. Once an article on the study is published, a publication package will be published on DataverseNL. This package includes the manuscript, procedures, raw data files, computer code, and processed data files.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Evers, PhD principal investigator
Leiden University
Questions about this trial
What is this clinical trial studying?
A study testing Online self-management intervention and Care-as-usual in people with Osteoarthritis and Musculoskeletal Diseases, run by Leiden University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain coping (time frame: Baseline, immediately after the intervention, at 6 weeks and 3 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.