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The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce.
To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness.
To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention.
Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated.
By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.
Having a rheumatic disease often leads to symptoms of pain, fatigue, and physical constraints that are part of a reduced health-related quality of life [
With the growing opportunities and use of the Internet, a Web-based self-management version of the ASMP intervention for patients with long-term conditions was developed in 2007 [
With the expansion of the Web-based intervention in the Netherlands, older adults with rheumatic diseases also expressed their need for a Web-based self-management intervention. In order to meet this need, the Dutch Arthritis Foundation gave us a grant to develop a Web-based intervention for adults from the age of 25 years and older. The goal of this research protocol was to describe (1) the theoretical considerations that guided the development of this Web-based intervention for adult patients with rheumatic diseases, (2) the contents of the intervention, (3) the results of a pilot study to study the usability of the intervention, and (4) the study design in order to examine the effectiveness of the intervention.
As we inferred from our experiences with the development and research pertaining to the Web-based intervention for the young adult group, collaboration with the end-users in all phases of development of a Web-based self-management intervention is crucial and influences the actual use, adherence, and effectiveness [
Although there is growing attention for interventions that are customized to individual patients with chronic diseases, the structure and contents are generally still protocol-based on group preferences [
An important part of the development phase consisted of a needs assessment, conducted by the combination of a focus group and concept mapping design (J.W. Ammerlaan, et al, unpublished data, 2016). Online focus group interviews among adult patients with rheumatic diseases in the Netherlands, a card sorting task, and hierarchical cluster analysis yielded an extensive overview of the individual preferences regarding structure and content. Patients preferred an intervention tailored to their needs, stage of life, and goals. Also, an expert patient as a trainer, the opportunity to be in contact and to share with others, and the ability to follow the intervention at one’s own pace were preferred. With respect to needs for content of the intervention, hierarchical cluster analysis yielded 11 clusters involving increasing individual knowledge of treatment and consequences for daily life, skills including managing emotions, managing, the fluctuations of disease, and dealing with health professionals and social authorities. Self-regulating their own lives, including requesting support from their spouse, family, or coworkers, setting boundaries and the ability to communicate adequately, and dealing with pregnancy or intimacy issues and taking care of kids. Based on the data from this needs assessment and the theoretical considerations, the first draft of the Web-based self-management intervention (in Dutch: ReumaUitgedaagd! Online) was developed.
ReumaUitgedaagd! Online is a Web-based, password protected, tailored, self- management intervention for adults with a rheumatic disease, aimed at enhancing patients’ self-management skills. The participants perform the intervention individually, are coached by a trainer, and have online contact with other participants on a discussion board. The role of the trainer is to support participants during the Web-based intervention in becoming a good self-manager and achieving their personal goals. The trainers are adults who also have a rheumatic disease. They are recruited through the website of the Dutch Arthritis Foundation and selected through assessments and interviews conducted by a professional coaching organization (Work21), in close cooperation with the Dutch Arthritis Foundation and the University Medical Center Utrecht. The selection process used questions about motivation, perceptions of self-management, the self-determination theory and strategies derived from the theoretical foundation, and goals of the Web-based intervention to identify those trainers who could adhere to the basic tenets of the intervention. Finally, the expert trainer was trained through a 3-day train-the-trainer (TTT) educational intervention. The TTT intervention consisted of following the intervention as a participant, knowledge of different themes, and teaching Web-based training skills. The trainers are given a volunteer contract and receive a stipend from the Dutch Arthritis Foundation. The basic needs of autonomy, competence, and social relatedness, derived from Self-Determination theory, are embedded in the intervention and combined with elements of skills training and modelling, based on the Self-efficacy theory [
The Web-based self-management intervention consists of four components: nine thematic modules (willing, knowing, skills, feeling, living together, influence, exercise, work, and moving on), a chat application, a discussion board, and a message box.
Each module involves a specific theme. Both informative text about the theme and exercises are included. The information and the exercises are supported by short videos in which people with a rheumatic disease or a member of the multidisciplinary team tell about their experiences with arthritis. The content of the modules is described in
Screen of the homepage, showing the nine modules of the online Reuma Uitgedaagd! (in Dutch).
The intervention includes three chat sessions between the participant with the trainer (after finishing module 1, after finishing module 3, and after finishing module 9). During the chat sessions, the trainer discusses the progress of the intervention and answers questions from participants. The duration of a chat session is approximately 15 to 30 minutes. The participant also has the ability to individually contact the trainer via a message box.
The purpose of the discussion board is to exchange experiences between participants and trainers. In some exercises the participants put their output on the discussion board to start a discussion. For instance, they report how they tend to deal with being dispirited and whether or not they feel the strategy is proving to be successful.
Based on the preferences of the research team, the design of the Web-based intervention was made attractive by using ‘colorful, real-life pictures of people of different ages’ to support information and exercises. Secondly, pictures of people, performing activities based on the content of the module, were used as pictograms to navigate. Thirdly, the videos to support the informative text of the modules were directed and produced by a professional company. Finally, a voice over was added to assist visually impaired participants.
Content of the Nine Modules of the Web-Based Self-Management Intervention and Exercises
Module | Contents | Exercises |
Self-management | Awareness of self-management | |
Priorities in life (getting to know yourself) | Evaluating self-management | |
Setting and achieving personal goals | Life values (priorities in life) | |
Formulating personal goals for the training | ||
A rheumatic disease: what does that mean? | Knowledge Quiz: what do you (already) know of your disease? | |
Treatment possibilities | Gaining insight into treatment and treatment goals | |
Getting control over one’s disease and treatment | Working together with your physician and health professional | |
Pain and fatigue diary | ||
Medication | Practice and evaluation of consultation in the hospital | |
A consultation in the hospital: how do you prepare yourself? | ||
Being in charge:making choices | Evaluating your own behavior: making choices | |
Problem solving | Circle of influence and engagement | |
Communication | Feedback in your daily life | |
To give and receive feedback | Saying no | |
Setting boundaries | Recognizing your own coping scale | |
Coping: dealing with consequences | ||
Self-assertiveness test | ||
Having a rheumatic disease; what’s next? | Loss of health; what does that mean to you? | |
Consequences of having a rheumatic disease on your body, your mind, and socially | Feeling blue | |
Pain, fatigue, and negative emotions | Evaluation of a situation to get insight into the influence of one’s thoughts, behavior, and feelings | |
Your own influence | Evaluation of the pain and fatigue diaries | |
Processing phases in the loss of health | Dealing with the loss of health | |
Tips for handling pain | Relaxation exercises | |
Tips for handling fatigue | To puzzle over: what can you do? | |
To rack one’s brain: what can one do about it? | ||
Communicating with family and friends | Relationships | |
Kids and stuff | Intimacy | |
Sexuality | ||
Asking for help from your representatives or friends | ||
Getting pregnant and having kids | Communicating with your partner | |
Taking care of kids | ||
Communicating with one’s children | ||
How to influence one’s environment? | Explain your disease and consequences | |
Dealing with lack of understanding (invalidation) | Asking for help: sharing experiences | |
Asking for help | ||
Exercise and having a rheumatic disease | Your exercises | |
Motion and physical activity | Exercise diary | |
Pain and overload | Action plan | |
Exertion and relaxation | Relaxation | |
Exercise and different rheumatic diseases | ||
Suitable work | What’s a suitable job for you? | |
Dealing with invalidation at work | Who knows that you have a rheumatic disease at work? | |
Dealing with fatigue and stress at work | Dealing with obstacles | |
Rights and obligations | ||
Going to school or university | ||
To apply for a job | ||
Preparing for an interview with your colleagues or boss | Preparing for an interview with your colleagues or boss | |
Being sick and getting back to work/school | ||
Work adaptions | ||
Your personal goals | Self-management: reflection of your own knowledge and skills | |
Action plan for the future | Action plan for the future | |
Evaluation | Evaluating your own goals | |
An example of an action plan |
The first draft of the Web-based self-management intervention was tested in a quantitative pilot study, using the three concepts of the Technology Acceptance Model (TAM) [
The participants of the pilot study were given 3-weeks’ access to the Web-based self-management intervention to examine and apply the contents of the intervention. After 3 weeks, the participants completed a Web-based questionnaire on usability (based on the TAM).
Adult patients with access to a computer with Internet, sufficient Internet skills, diagnosed with a rheumatic disease, and being able to read and write in Dutch were included. Participants were recruited through websites, Facebook, and Twitter accounts of the Dutch Arthritis Foundation [
Demographic variables like age and type of rheumatic disease and self-reported Internet-skills (measured on a 5-point Likert scale from very bad to very good) were collected to describe the group. Usability as primary outcome measure was operationalized using the three concepts of the TAM with 11 questions on a 5-point Likert scale (from totally disagree to totally agree) with the possibility to give additional comments. One question on ‘overall satisfaction’ was added, using a numeric rating system (NRS) from 0 (not satisfied) to 10 (most satisfied) (see
Perceived usefulness
Did you perceive the content of the intervention to be useful?
Did you perceive the content of the intervention as understandable?
Did you perceive the exercises in the intervention to be useful?
Did you perceive the content of the exercises as understandable?
Did you perceive the intervention to be useful as a supplement to usual health care?
Did you perceive the intervention to be useful in dealing with the consequences of having a rheumatic disease in daily life?
Perceived ease of use
Did you perceive the Web-based self-management intervention to be easy to navigate?
Could you easily find what you were looking for?
Intention to use
Would you participate again, knowing now the content and structure?
Would you recommend the Web-based self-management intervention to others (knowing now the content and structure)?
Overall satisfaction
How do you rate your overall satisfaction with the intervention?
How do you rate the look and feel of the intervention?
Twenty-three respondents (22 women, mean age of 47 years) were given access to the Web-based intervention to test the usability. Most of them were diagnosed with inflammatory arthritis (16/23, 70%). Other diagnoses were osteoarthritis and fibromyalgia. Ninety-one percent (21/23) of participants rated their Internet-skills as ‘very good’. Two participants rated their skills as average.
Ninety-one percent (21/23) of the participants indicated the content and exercises as easy to understand and useful (ie, agree/totally agree on the Likert-scale). The majority of the participants (21/23, 91%) indicated the intervention to be useful in dealing with the consequences of having a rheumatic disease in daily life. The navigation on the site itself was rated somewhat lower with 70% (16/ 23) of participants being critical about the menu with thematic modules on the homepage and finding their way on the website. The look and feel of the intervention was recognized by 78% (18/23) of participants as pleasant.
In terms of intention to use: 78% (18/23) would participate in the Web-based intervention themselves and 91% (21/23) would recommend it to others. The mean satisfaction score of the Web-based intervention was rated 7.9 (range 4-10) on a scale of 0 (not satisfied) to 10 (most satisfied).
Considering the three concepts, we concluded that the Web-based intervention was to be recognized as being useful and easy to use. Participants stated that they were likely to participate; now they were familiar with the content and structure. To improve the navigation and menu of the intervention, numbers were added to each module in order to indicate the sequence of the modules
To evaluate the Web-based self-management intervention, we have planned a randomized controlled trial with an intervention and a self-help control group and a 6-month follow-up period among adults in the Netherlands having a rheumatic disease. The control group will be put on a waiting list and will cross-over to the intervention after 6 months. Participants in the intervention group will be given access to the Web-based self-management intervention ReumaUitgedaagd! Both groups will receive usual care, based on the medical standard guidelines of the Dutch Association of Rheumatology [
Because we already have a Web-based self-management intervention for young adults (from 16-25 years), adults ≥26 years, having a rheumatic disease, diagnosed at least 2 years before inclusion by a rheumatologist or a General Practitioner, are eligible for this study. In addition to having an Internet connection, patients need to have proficiency in the Dutch language and not having previously participated in a self-management intervention. Having a psychiatric disorder or being under (recent) treatment by a psychologist or psychiatrist are criteria for exclusion from this study. The participants will be recruited via the Internet through websites, Facebook, and Twitter accounts of the Dutch Arthritis Foundation [
Randomization will take place after informed consent and completion of the goal-setting procedure, using a computerized application of the University Medical Center Utrecht. This is an automated process with no interference from the investigators. We will use a stratified block randomization to decrease the likelihood of imbalance between three conditions (arthritis, osteoarthritis, and soft-tissue rheumatism). After randomization, the participants will be informed by the researcher if they are assigned to the intervention or control group. The participants of the intervention group will then start with the Web-based self-management intervention and be asked to work through the intervention within 2 months.
In this study individual outcome measures, generic outcome measures, and process outcomes measures will be collected, most of them via the Internet with questionnaires, self-reported by the participants. Demographic variables including age, sex, disease duration, diagnosis, marital status, current treatment, education level, work, and comorbidity at baseline will be collected in order to characterize the group of participants. The timeframe for collecting the outcome measures is displayed in
Time frame and flow-chard study design.
A crucial and novel aspect of this study is that the intervention is customized to the needs of the participant. This is one of the reasons why the change –progress toward– the main personal goal is chosen as the primary individual outcome measure. Studies show that on individual outcome measures the effect is larger than on generic outcome measures [
The personal goals are measured with a Web-based NRS. The participant is asked to indicate with a score from 0 to 10 on the NRS to what extent he or she achieved this goal. The content of the primary goal can differ per person but the rate of change can be compared between subjects because they are measured on the same scale.
The following generic outcome measures are assessed (all self-reports): pain, disease activity, self-management skills, quality of life, and sick leave.
Self-reported pain and disease activity will be scored by the participant on a Web-based NRS from 0 to 10. The higher the score, the more pain or disease activity.
Self-management will be measured with the Dutch translation of the Web-based Health Education Impact Questionnaire (heiQ) [
Quality of life will be assessed with the Web-based Medical Outcomes Study 12-item Short Form Health Survey (SF-12) [
Sick leave is measured with three questions regarding (1) working in a paid job (yes/no/how many days a week), (2) sick leave during the past month, and (3) reasons for sick leave. Two measures of health care assumption are recorded as follows: self-reported visits to general practice, medical specialist, or physiotherapist, and whether or by whom support is offered to achieve the personal goals.
Feasibility is measured as a process outcome in the effectiveness study to evaluate the intervention in real-life in a larger group. Feasibility will be measured within the intervention group using the three concepts of the TAM [
Use and adherence of the Web-based self-management intervention are digitally measured by Google Analytics within the intervention group. This was done by counting: (1) the number of starting and finishing participants within the time period, (2) the number of started and finished exercises, (3) the number of logins, (4) the number of messages that were put on the discussion board, (5) the number of contact moments with the expert trainers, and (6) the number of messages on the message box.
To be able to compare our results with previous evaluations of self-management interventions, power calculation was based on the generic outcome parameters. In previous research, the generic measures of self-efficacy (which is close to our measurement of self-management skills) and functioning (which is part of our quality of life measurement), small to moderate effect-sizes (d) were found varying from 0.21 to 0.42 [
As the crucial aspect of the current study is that the intervention is customized to the needs of the individual participant, the change on the main individual goal is chosen as primary outcome measure, and the change on the other two individual outcome measures (evaluation of the second and third personal goal) is considered important as well. Our sample size is large enough to examine differences in this primary outcome measure. Based on previous studies with individual outcome measures [
Demographic and disease-specific outcomes will be descriptively presented per group, where possible, with means and standard deviations. The Consolidated Standards of Reporting Trials statement [
Patient inclusion and data collection will be completed in February 2017.
A comprehensive assessment of the preferences and needs of patients with a rheumatic disease was used to build ReumaUitgedaagd! Online, guided by Self-Determination theory [
According to the MRC framework [
Strong features of this Web-based intervention are that it is guided by needs and preferences of patients, that the precise contents of the interventions are customized to the individual patient, and that also the outcome measures fit the self-management goals that are really important to the individual patient. This makes the intervention an example of personalized, patient-centered care. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.
arthritis self-management intervention
health education impact questionnaire
medical research council
numeric rating scale
short form health survey
technology acceptance model
train-the-trainer
All patients who participated in the study are gratefully acknowledged.
The usability study and the randomized controlled trial are supported by a grant from the Dutch Arthritis Foundation.
None declared.