FeasibilityNCT06063252
Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA)
A study testing NISMA in people with Feasibility, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Even though medical treatment has improved within the last 10-15 years, patients with inflammatory arthritis (IA) still experience reduced quality of life, depression, anxiety, changes in family roles, work life, and social relationships. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility
- What is being tested?
- NISMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 23 Apr 2023
- 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
- Adult persons (≥18 years)
- Diagnosed with one of the following diagnoses: Rheumatoid arthritis (ICD10 diagnoses: M05.3, M05.9, M05.8, M06.9), Spondyloarthritis (ICD10 diagnoses: M45.9, M46.1, M46.8, M46.9) or Psoriatic arthritis (ICD10 diagnoses: M073.A, M073.B), within the last 6 months.
Who cannot join
- Insufficient language skills to discuss the topics in the intervention in Danish
- In chemotherapy treatment for malignancies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Luise Holberg Lindgren
Glostrup Municipality, Capital Region, 2600
About this study
Official title: Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA) A Descriptive Randomized Controlled Feasibility Study
Even though medical treatment has improved within the last 10-15 years, patients with inflammatory arthritis (IA) still experience reduced quality of life, depression, anxiety, changes in family roles, work life, and social relationships. Particularly the newly diagnosed, require regular consultations and available support from health professionals, to be able to handle emotional, social, and physiological challenges.
The hypothesis is that a self-management intervention can improve patients' ability to monitor their arthritis and respond to symptoms, reduce the risk of co-morbidities, and improve adherence. And also, that they can develop cognitive, behavioral, and emotional strategies to manage life with arthritis. There is a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. In a previous study, the investigators developed a self-management intervention, and now wish to test it in a randomized feasibility study.
Read the detailed description
RATIONALE FOR NISMA PROJECT
The hypothesis is that a self-management intervention can help patients develop behavioral and emotional strategies to manage life with arthritis. There a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. Therefore, the investigators wish to develop a self-management intervention.
Aim
The overall aim of this study is to determine whether a full-scale randomized controlled trial, which aims to increase self-management in patients with newly diagnosed IA, is possible. The investigators wish to identify methodological, clinical, and procedural uncertainties in delivering a self-management intervention. Furthermore, to investigate outcomes related to recruitment, including adherence, retention, accrual rate, characteristics of the sample, and reliable recruitment methods.
Design
This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1) to assess the proposed method in the definitive RCT.
Overall Setting
The intervention will take place at the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark.
- Conditions
- Feasibility
- Being tested
- NISMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NISMABehavioural
The intervention NISMA is a nine-month intervention and consisted of four individual sessions and two group sessions. The theoretical frame is Social Cognitive Theory, along with Acceptance and Commitment Therapy (ACT), to support the enhancement of self-efficacy. It involves four individual face-to-face sessions with a nurse and two group sessions (5-7 patients) with a nurse, an occupational therapist (OT), and a physiotherapist (PT), with the nurse being the facilitator. Every session has a specific topic and, in every session, a person-centered approach was used to address current problems and secure relevance.
Participants in the control group receive usual care, and the intervention group receives both usual care supplemented with the intervention.
| Study group | Role | What they receive |
|---|---|---|
| controlgroup | No intervention | Usual care |
| intervention group | Experimental | receive self-management intervention Receives: Behavioral: NISMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rate will be assessed as the number of patients recruited out of the number of eligiable patients
Measured: Assessed at 3 months
Retention
Retention rate will be assessed as the number of patients who wtihdrew from the study out of the total number of patients.
Measured: Assessed at 9 months
Adherence
Adherence to intervention protocol of the study assessed as the number of sessions attended out of the total number of sessions available
Measured: Assessed at 9 months
Secondary outcomes (13)
Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)
Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)
Measured: Assessed at baseline and 9 months
Pain intensity measured by the Visual analog scale for pain (VAS)
Pain measured by the Visual analog scale for pain. Score from 0-100. Higher score is more pain.
Measured: Assessed at baseline and 9 months
Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ)
Functional status measured by the Multi-Dimensional Health Assessment Questionnaire. Score from 0-3. Higher score is more disability.
Measured: Assessed at baseline and 9 months
Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF)
Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF). It consists of 20 questions with four responses in four categories: physical fatigue, living with fatigue, cognitive fatigue, and emotional fatigue. Higher score is more fatigue.
Measured: Assessed at baseline and 9 months
Fatigue measured by the visual analog scale for fatigue (VAS-fatigue)
Fatigue measured by the visual analog scale for fatigue (VAS-fatigue). Score from 0-100. Higher score is more fatigue.
Measured: Assessed at baseline and 9 months
Health Literacy was measured by the Health Literacy Questionnaire (HLQ)
Health Literacy was measured by the Health Literacy Questionnaire. Independent scales measuring health literacy on a continuous scale. Scores range between 1 to 4 (for first 5 scales) and 1 to 5 (for scales 6 to 9).
Measured: Assessed at baseline and 9 months
Health related quality of life measured by the EuroQol-5 Dimension (EQ5D)
Quality of life measured by the EuroQol-5 Dimension. measures the patient's self-rated health status. Ranging from -0.624 to 1, higher is better.
Measured: Assessed at baseline and 9 months
Illness perception measured by the Brief Illness Perception Questionnaire (B-IPQ)
Illness perception measured by the Brief Illness Perception Questionnaire. Score from 1-10. Higher is worse.
Measured: Assessed at baseline and 9 months
Self-efficacy measured by the Arthritis specific self-efficacy measurement tool (ASES)
Self-efficacy measured by the Arthritis specific self-efficacy measurement tool. Score from 1-10. Higher score is better
Measured: Assessed at baseline and 9 months
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Anxiety and depression measured by the Hospital Anxiety and Depression Scale. ). HADS is a 14-item questionnaire that assesses levels of anxiety and depression symptoms in medically ill patients in two 7-item sub-scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 or higher indicate the probable presence of a mood disorder. Symptoms of anxiety and depression were defined by scores of 8 or higher.
Measured: Assessed at baseline and 9 months
Disease activity RA measured the Disease Activity Score in 28 joints (DAS28)
Disease activity in rheumatoid arthritis, measured the Disease Activity Score in 28 joints with erythrocyte sedimentation rate. Composite measures, in which multiple aspects of the disease are combined in a total score of the level of disease activity. Higher is worse.
Measured: Assessed at baseline and 9 months
Disease activity SpA measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Disease activity in patients with spondyloarthritis, was measured by the Bath Ankylosing Spondylitis Disease Activity Index. The sum score ranges from 0 to 100 with higher values indicating more active disease
Measured: Assessed at baseline and 9 months
Disease activity PsA measured by the the Disease Activity index for PSoriatic Arthritis (DAPSA).
Disease activity in patients wiht psoriatic arthritis, was measured by the Disease Activity index for PSoriatic Arthritis. Composite measures, in which multiple aspects of the disease are combined in a total score of the level of disease activity. Higher is worse.
Measured: Assessed at baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Nov 2021
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
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 FeasibilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1)
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bente Appel Esbensen, Glostrup University Hospital, Copenhagen
- Investigators
- Bente A Esbensen, Professor, Principal investigator, Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063252
- Sponsor's protocol ID
- GlostrupUHN
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is feasibility outcome data, sharing data i not likely to be relevant
Publications
Lindgren LH, Thomsen T, Hetland ML, Aadahl M, Kristensen SD, de Thurah A, Esbensen BA. A self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study. Pilot Feasibility Stud. 2025 Feb 11;11(1):15. doi: 10.1186/s40814-025-01601-z.
PubMed 39934926
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA) A Descriptive Randomized Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT06063252
- Acronym / sponsor ID
- GlostrupUHN
- Conditions
- Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 2 Oct 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.
Even though medical treatment has improved within the last 10-15 years, patients with inflammatory arthritis (IA) still experience reduced quality of life, depression, anxiety, changes in family roles, work life, and social relationships. Particularly the newly diagnosed, require regular consultations and available support from health professionals, to be able to handle emotional, social, and physiological challenges.
The hypothesis is that a self-management intervention can improve patients' ability to monitor their arthritis and respond to symptoms, reduce the risk of co-morbidities, and improve adherence. And also, that they can develop cognitive, behavioral, and emotional strategies to manage life with arthritis. There is a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. In a previous study, the investigators developed a self-management intervention, and now wish to test it in a randomized feasibility study.
Detailed description
RATIONALE FOR NISMA PROJECT
The hypothesis is that a self-management intervention can help patients develop behavioral and emotional strategies to manage life with arthritis. There a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. Therefore, the investigators wish to develop a self-management intervention.
Aim
The overall aim of this study is to determine whether a full-scale randomized controlled trial, which aims to increase self-management in patients with newly diagnosed IA, is possible. The investigators wish to identify methodological, clinical, and procedural uncertainties in delivering a self-management intervention. Furthermore, to investigate outcomes related to recruitment, including adherence, retention, accrual rate, characteristics of the sample, and reliable recruitment methods.
Design
This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1) to assess the proposed method in the definitive RCT.
Overall Setting
The intervention will take place at the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1)
| Arm | Type | Receives |
|---|---|---|
| controlgroup | No intervention | –Usual care |
| intervention group | Experimental | Behavioral: NISMAreceive self-management intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult persons (≥18 years)
- Diagnosed with one of the following diagnoses: Rheumatoid arthritis (ICD10 diagnoses: M05.3, M05.9, M05.8, M06.9), Spondyloarthritis (ICD10 diagnoses: M45.9, M46.1, M46.8, M46.9) or Psoriatic arthritis (ICD10 diagnoses: M073.A, M073.B), within the last 6 months.
Key exclusion criteria (2 listed)
- Insufficient language skills to discuss the topics in the intervention in Danish
- In chemotherapy treatment for malignancies
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 |
|---|---|---|
| NISMAThe intervention NISMA is a nine-month intervention and consisted of four individual sessions and two group sessions. The theoretical frame is Social Cognitive Theory, along with Acceptance and Commitment Therapy (ACT), to support the enhancement of self-efficacy. It involves four individual face-to-face sessions with a nurse and two group sessions (5-7 patients) with a nurse, an occupational therapist (OT), and a physiotherapist (PT), with the nurse being the facilitator. Every session has a specific topic and, in every session, a person-centered approach was used to address current problems and secure relevance. Participants in the control group receive usual care, and the intervention group receives both usual care supplemented with the intervention. | Behavioural | intervention group |
Primary outcome
Recruitment
Time frame: Assessed at 3 months
Recruitment rate will be assessed as the number of patients recruited out of the number of eligiable patients
Retention
Time frame: Assessed at 9 months
Retention rate will be assessed as the number of patients who wtihdrew from the study out of the total number of patients.
Adherence
Time frame: Assessed at 9 months
Adherence to intervention protocol of the study assessed as the number of sessions attended out of the total number of sessions available
13 secondary outcomes
Physical activity measured by the Physical activity and sedentary time questionnaire (FAST)
Time frame: Assessed at baseline and 9 months
Pain intensity measured by the Visual analog scale for pain (VAS)
Time frame: Assessed at baseline and 9 months
Functional status measured by the Multi-Dimensional Health Assessment Questionnaire (MD-HAQ)
Time frame: Assessed at baseline and 9 months
Fatigue measured by the Bristol Reumatoid Arthritis Fatigue Questionnaire (BRAF)
Time frame: Assessed at baseline and 9 months
Fatigue measured by the visual analog scale for fatigue (VAS-fatigue)
Time frame: Assessed at baseline and 9 months
Health Literacy was measured by the Health Literacy Questionnaire (HLQ)
Time frame: Assessed at baseline and 9 months
Health related quality of life measured by the EuroQol-5 Dimension (EQ5D)
Time frame: Assessed at baseline and 9 months
Illness perception measured by the Brief Illness Perception Questionnaire (B-IPQ)
Time frame: Assessed at baseline and 9 months
Self-efficacy measured by the Arthritis specific self-efficacy measurement tool (ASES)
Time frame: Assessed at baseline and 9 months
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessed at baseline and 9 months
Disease activity RA measured the Disease Activity Score in 28 joints (DAS28)
Time frame: Assessed at baseline and 9 months
Disease activity SpA measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Assessed at baseline and 9 months
Disease activity PsA measured by the the Disease Activity index for PSoriatic Arthritis (DAPSA).
Time frame: Assessed at baseline and 9 months
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 2 Oct 2023.
- Derived from this study: PubMed 39934926Lindgren LH, Thomsen T, Hetland ML, Aadahl M, Kristensen SD, de Thurah A, Esbensen BA. A self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study. Pilot Feasibility Stud. 2025 Feb 11;11(1):15. doi: 10.1186/s40814-025-01601-z.
- Individual participant dataSharing planned: No. As this is feasibility outcome data, sharing data i not likely to be relevant
Related trials for Feasibility
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
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.
Bente A Esbensen, Professor principal investigator
Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NISMA in people with Feasibility, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 2 inclusion and 2 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Recruitment (time frame: Assessed at 3 months). The study lists 3 primary outcomes in all. 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 NCT06063252, 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 2 Oct 2023.