Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA) A Descriptive Randomized Controlled Feasibility Study
Phase: NA
Conditions: Feasibility
Sponsor: Glostrup University Hospital, Copenhagen

 
 
 
November 2021 
Newly diagnosed with inflammatory arthritis –                
A protocol for a self-management intervention (NISMA) 
NCT number: Not yet assigned  
Luise Holberg Lindgren 
01-11-2021 
 

Introduction 
Despite the increasing number of new drugs and treatment regimes, complete long-term disease remission 
is not achieved for many patients with inflammatory arthritis (IA) [1–3]. In addition, even in remission, 
patients with IA will experience symptoms, and due to the fluctuating nature of the arthritis, symptoms will 
come and go throughout life with varying intensity [2]. Therefore, an important but often insufficient aspect 
of care in patients with IA is empowering patients to acquire a good understanding of their disease and build 
their ability to deal effectively with its practical, physical, and psychological impacts of it. Self-management 
skills can be helpful in [4].  
 
Background  
Inflammatory arthritis (IA) covers diseases caused by an overactive immune system. These diseases manifest 
mainly with inflammation of the joints felt as joint pain and stiffness, but IA can also affect other connective 
tissues, including the lungs, heart, eyes, skin, and other organs. Importantly, when inflammation affects any 
part of the body, it can result in irreversible damage [5–9]. The most common types of IA are Rheumatoid 
Arthritis (RA), Spondyloarthritis (SpA), and Psoriatic Arthritis (PsA) [5], and all have a major impact on 
patient’s life and health.   
These three types of IA affect more than 2% of the population with considerable variation worldwide, 
depending on ethnicity [5–9]. IA can occur at any age and in both sexes. The cause of IA is poorly 
understood, but we know that it involves both genetic and lifestyle factors [8,10,11]. Approximately 2,000 
people are diagnosed annually with RA, SpA, or PsA  [12,13]. 
The newly diagnosed are particularly challenged. They are about to begin a life with lifelong pharmacological 
treatment, regular blood tests, symptoms as pain, fatigue, sleep disturbances and increased risk of 
developing co-morbidities such as depression, cardiovascular disease, diabetes, and osteoporosis. Some 
experience of reduced quality of life, altered body image and changes in family, work, and social life, and 
struggles with the fluctuation of the disease. Several studies have shown that newly diagnosed patients 
require regular consultations and available support from healthcare professionals (HPs) to deal with 
emotional, social, and physical challenges [14–20]. In addition, they have a wide range of educational needs, 
such as knowledge and management of the disease, knowledge of adverse effects and risk factors, non-
pharmacological treatment including strategies for lifestyle, pain control and self-help methods, as well as 
activity regulation, physical activity, behavior change and psychological support especially immediately 
following IA diagnosis.  
 
Self-management  
Previous research suggests that increased self-management - defined as the individual's ability to manage 
symptoms, treatments, lifestyle changes and psychosocial and cultural consequences of illness - can improve 
the quality of life in patients with chronic illness. However, in patients with arthritis, self-management 
interventions have produced small to medium effect sizes, and the content, settings, and outcomes of the 
tested interventions have been very heterogeneous [21–25]. Thus, these interventions are difficult to 
compare and transfer to another setting. Also, the mechanisms of impact in these interventions remain 
relatively unclear [21–25]. After a thorough review of the literature, there is a lack of research on self-
management interventions that are specifically targeted at newly diagnosed patients with inflammatory 
arthritis.  
Rationale for NISMA project 
Our 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, emotional strategies to manage life with arthritis. There is to our knowledge, a 
lack of disease specific evidence, in integrated interventions with multiple components targeting patients 

with a newly diagnosed IA. Therefore, we developed a self-management intervention. The development I 
reported elsewhere [26]. 
 
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.  
We wish to identify methodological, clinical, and procedural uncertainties in delivering a self-management 
intervention. Furthermore, we wish 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 
method proposed for use in the definitive RCT. 
Overall Setting 
The intervention will take place at the Center for Rheumatology and Spine Diseases, Rigshospitalet, 
Denmark. 
 
Participants  
Patients with IA covering following diagnoses: SpA, PsA or RA according to the International Classification of 
Disease and Related Health Problems.  
Inclusion criteria: IA diagnosis within 6 months, 18 years of age or older and able to discuss the topics in the 
intervention in Danish.  
Exclusion criteria: Patients in kemo-therapy treatment for malignancies.   
 
Recruitment 
A rheumatologist or rheumatology nurse from the outpatient clinic will briefly inform possible eligible 
patients about the trial.  
 
Allocation and blinding: Randomization will be performed after baseline data collection and conducted using 
a computerized random number generator algorithm. Participant and clinician blinding are not possible due 
to the nature of the intervention.  
 
Usual care 
Usual care consists of planned sessions with a rheumatologist and occasionally a nurse.  
Participants in the control group receive usual care, and participants in the intervention group receive both 
usual care supplemented with the intervention.   
 
Intervention 
NISMA is a nine-month intervention and consist of four individual sessions and two group sessions. The 
theoretical frame is Social Cognitive Theory (25,26),  along with Acceptance and Commitment Therapy (ACT) 
(27), to support the enhancement of self-efficacy. It involves four individual 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 is used to secure relevance (23).   
For further details see Figure 2. Or the development study (23).   
 
 
Training of health professionals involved in delivering the intervention 

The research team developed a comprehensive manual, describing each session and the overall intervention 
strategy and framework. Also, we held a two-day competence program in October 2021 to train HPRs in 
delivering the intervention to secure fidelity and acceptance.  
Table 1. The NISMA self-management intervention (sessions, topics, timeline, duration, aims and activities) 
Session type 
Topic  
Timeline 
Duration Aim 
Activity 
First individual 
session with a 
nurse  
Medical 
management 
14 days 
after 
baseline  
 
1.5 
hours 
To establish a 
partnership 
between patient 
and nurse, based 
on patient 
values, and 
health history.  
To increase 
knowledge 
about self-
management 
and physical 
state. 
o Introduction to self-
management and the 
frame of the sessions.  
o What is arthritis – 
education and 
information about 
principles of medical 
treatment.   
o Management of 
individual problems – 
help to achieve 
performance 
accomplishment through 
problem-solving and 
action planning.  
Second 
individual 
session with 
the nurse  
 
Emotional 
management 
 
6 weeks 
after 
baseline 
1 hour 
To increase 
knowledge 
about emotional 
reactions. 
o Normal emotional 
reactions including 
acceptance and crisis 
theory.   
o Management of 
individual problems – 
help to achieve 
performance 
accomplishment through 
problem-solving and 
action planning.  
Third individual 
session with a 
nurse  
 
Role 
management 
3 
months 
after 
baseline  
 
1 hour 
To help prioritize 
and address 
challenges 
related to work 
and social life. 
o Social relationships, 
identity, and loneliness. 
The outside world's 
expectations versus own 
expectations.  
o Management of 
individual problems – 
help to achieve 
performance 
accomplishment through 
problem-solving and 
action planning.  
First group 
session with a 
nurse, 
occupational- 
Symptom 
management 
4 
months 
after 
baseline  
2 hours 
To help patients 
meet other 
patients and 
make a room for 
o Symptoms such as flare, 
pain, fatigue, and sleep 
problems. Symptom 
interactions.  

and 
physiotherapist 
 
 
observational 
learning about 
symptom 
management. 
o Each patient tells a little 
about themselves and 
shares their experiences 
with IA and IA symptoms.  
Second group 
session with a 
nurse, 
occupational- 
and 
physiotherapist 
Lifestyle and 
co-morbidity  
6 
months 
after 
baseline  
 
 
2 hours 
To help patients 
meet other 
patients and 
make a room for 
observational 
learning in 
relation to 
lifestyle 
management. 
 
o Each participant shares 
their experiences since 
the last session.  
o Lifestyle. What is good 
and what is bad - why? 
Identify the need for 
lifestyle changes and 
possible barriers and 
solutions. Patients share 
previous experiences 
with lifestyle changes. 
o Management of 
individual problems – 
problem-solving and 
action planning. 
Fourth 
individual 
session with a 
nurse 
Future use of 
the 
healthcare 
system and 
round up 
9 
months 
after 
baseline  
1 hour 
To increase 
health literacy. 
o Use of healthcare and 
future collaboration with 
healthcare professionals.  
o Management of 
individual problems – 
problem-solving and 
action planning.  
 
 
Participants in the control group receive usual care, and the intervention group receives both usual care 
supplemented with the intervention.   
 
Sample size considerations 
As this is a feasibility study, sample size calculation is not relevant [27]. However, the steering committee 
anticipates that 20 patients (10 in the intervention group and 10 in the control group) will give us sufficient 
data to answer questions related to feasibility outcome measures, including estimation of potential 
recruitment rates, intervention adherence and rates of completion of data outcome tools.  
 
Outcomes  
In this feasibility study we will explore different feasibility outcomes and patient reported outcome measures 
(PROMS) to find suitable outcome measures for the definitive RCT.  
Data collection, measurements and follow up (Figure 3) 
Socio-demographic and lifestyle data will be collected at baseline. Data of the outcome measures described 
below will be measured at baseline and by the end of the intervention (9 months). The self-administered 
questionnaires are entered in the electronic project manager tool REDCap.  
The patient reported outcome measures 
• 
Physical Activity and Sedentary Time (FAST) 
• 
Functional status measured by Modified Health Assessment Questionnaire (MHAQ) 

• 
Pain measured by VAS  
• 
Fatigue measured by Bristol Rheumatoid Arthritis Fatigue Questionnaire (BRAF) and VAS 
• 
Health literacy measured by Health Literacy Questionnaire (HLQ) 
• 
Quality of Life measured by European Quality of Life (EQ5D) 
• 
Anxiety and Depression measured by The Hospital Anxiety and Depression Scale (HADS) 
• 
Illness intrusiveness measured by Illness Intrusiveness Rating Scale (IIRS) 
• 
Self-efficacy measured by Arthritis specific Self-Efficacy measurement tool (ASES). 
 
Blood samples and blood pressure measurement  
Lifestyle regulation measured by total cholesterol, and glycated hemoglobin HbA1c, height, weight and 
blood pressure.  
Information from patient journals 
Diagnosis (including IgM-reumafaktor and Anti-CCP) and disease duration will be obtained in the electronic 
database DANBIO.  
Pharmacological treatment, joint-score DAS28, CDAI, BASDAI or DAPSA depending on the rheumatic 
diagnosis (number of tender joints, swollen joints and VAS-global), and structural damage will be obtained 
from both DANBIO and SundhedsPlatformen to achieve baseline and follow-up information.  
 
Analysis  
Quantitative analyses of feasibility outcome measures  
The primay analysis will be of feasibility outcomes. We will report the numbers of eligible participants seen 
over the recruitment period, and the resulting rates of recruitment, retention, and data completion. Non-
completers will be characterized. Also, data collection methods will be evaluated.  
 
Patient reported outcome analysis 
We will assess the performance of potential outcome measures to determine the appropriate sample size 
for a definitive trial. In addition, we will ascertain data completeness of the instruments and any potential 
bias in the completion of follow-up data to inform the choice of instruments in a future trial. The outcome 
data will be presented in simple descriptive tables presenting percentages, means and standard deviations. 
 
 

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