A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial

Suffering a chronic disease increases the risk for the development of secondary conditions and disabilities that often lead to further declines in health status, independence, functional status, life satisfaction, and overall quality of life [2]. Aside from the physical effects and requirements concerning lifestyle changes, a chronic disease often has major psychological and social consequences for patients. Instead of being seen as a ‘distinct biological entity existing alone and apart from the person’ [3], a chronic disease often becomes part of the identity of a person. In essence, all chronic diseases present a similar set of challenges to the patients and their families including dealing with symptoms, disability, emotional impact, complex medical regimens, difficult lifestyle adjustments, and securing helpful medical care [4]. According to the International Classification of Functioning, Disability and Health (ICF), individuals with chronic and disabling conditions are fully capable of being healthy and experiencing a satisfying subjective quality of life [2, 5]. Notwithstanding this perspective, psychological distress is common in persons with polyarthritis [6], indicating that adaptation to the disease is not necessarily natural. For example, patients with rheumatoid arthritis (RA), one of the most common forms of polyarthritis, experience elevated levels of depressive mood and anxiety in comparison with healthy controls [7, 8]. Research indicates 20 to 40% of RA patients suffer from heightened depression and anxiety levels [7, 9‐12], and depressive and anxiety symptoms are seen as key indicators of unsuccessful adaptation to polyarthritis. However, the absence of psychological distress is not the only essential outcome of adaptation; well-being is similarly essential [5, 12, 13]. For example, emotional well-being is found to predict long-term prognosis of physical illness; higher levels of emotional well-being tend to benefit recovery and survival rates [14].

The inclusion of the following three constructs reflects a comprehensive view on adaptation: positive affect, purpose in life and social participation. Studies have shown that, when levels of pain are elevated in patients with arthritis, positive affect was able to prevent an increase in negative affect [15, 16]. Furthermore, the level of purpose in life of people with RA was found to be lower in comparison with healthy persons [17] and other studies showed that polyarthritis had a negative influence on the social participation and the work ability of the people affected [18‐20]. We hope to capture the full effect of the goal management intervention by taking into account the influence the intervention has on both negative and positive indicators of adaptation to polyarthritis.

The management of most chronic diseases is an extensive responsibility that takes place mostly outside the healthcare system, as people have to manage a chronic disease everyday in combination with possibly conflicting roles and tasks [21]. In fact, the patient, family and community have become active participants in managing chronic disease [22]. Therefore, active self-management and interventions supporting patients in the acquisition of skills and techniques to that help patients learn to live with their disease are seen as essential [23]. A wide variety of self-management interventions has been developed for several chronic conditions. Self-management is ‘the individuals’ ability to manage the symptoms, treatment, physical and psychosocial consequences and lifestyle changes inherent in living with a chronic condition’ [24]. Reasonable evidence exists that self-management interventions are beneficial for a wide population of people with chronic diseases, for example, persons with diabetes, hypertension, heart disease and macular degeneration [25, 26].

Despite receiving substantial attention in the literature, fewer benefits attained by persons with inflammatory arthritis have been reported [25]. Usually the effects of self-management interventions found for people with inflammatory arthritis are negligible to small [23, 27]. Also, improvements are rarely sustained over a longer time (e.g., 9 to 14 months follow-up) [27‐29]. The aforementioned term ‘self-management’ is used in literature to describe both health-oriented and disease management interventions [26], and this may cause confusion regarding the content and focus of interventions. The most frequently offered and studied self-management program for people with arthritis is the Arthritis Self-Management Course [30, 31], in which common problems with day-to-day care of arthritis patients are central.

Most self-management interventions deal with the medical and behavioral management of a chronic disease, but changing roles and emotional distress due to the disease are not systematically incorporated into intervention programs [26]. Health protection or disease management interventions are motivated by the desire to control and manage illness and its consequences [32] and accommodate the unilateral focus on disease and disability. Health promotion, in contrast, is not disease or illness specific, but has illness or disability as context [33]. Moreover, health promotion interventions are intended to promote health and well-being, reflecting the aforementioned perspective of the ICF [5] that individuals with chronic and disabling conditions are fully capable of being healthy and experiencing a satisfying quality of life. Although both health promotion interventions and disease management interventions may focus on similar behaviors (e.g., exercise and medication adherence for persons with arthritis), there is a critical difference in the key outcomes assessed. Studies on disease management interventions usually do not include positive psychological and social well-being measures as outcomes. As opposed to common outcome measures of disease-specific self-management interventions (e.g., pain and disability), the outcomes of health promotion interventions should reflect the broad perspective of the WHO on adaptation to a chronic disease [5]: the experience of quality of life and being healthy in psychological and social terms.

This article introduces a health promotion intervention based on goal management theory developed for people with polyarthritis. Instead of a focus on the management of the disease (as, for example, delivered by the Arthritis Self-management Course), attention is given to how the patient can cope with activities and life goals that have become impossible to attain or are threatened due to arthritis [12]. We will explain the theory upon which the intervention is based in the next sections.

The key features of the goal management intervention arise from the characteristics of a health promotion intervention (Table 1). Although these key features are interrelated, we briefly discuss them individually. Firstly, the aim of the intervention is to improve psychological health as well as social and physical functioning. These concepts are intertwined and the intervention is, therefore, aimed to all three concepts. Secondly, the aim of the intervention follows the idea that a holistic approach comprises all aspects of the patient’s life. Thirdly, the perspective is person-focused as opposed to an orientation towards a patient-centered disease held by most self-management interventions. In a person-focused view, body systems are seen as interrelated [34] and the illness as experienced by the patient becomes central. This perspective is opposed to a disease or outsiders’ viewpoint. In a disease perspective, the focus is placed on a set of symptoms that together form a disease, which implies a particular treatment. Multimorbidity or psychosocial problems play no explicit role in this perspective. The fourth point is that the content of the goal management intervention centers around capabilities and personal potential, and, therefore, can be applied in different disease populations.

Fifth, patients give substance to their own personal trajectory, in contrast to self-management interventions with a predetermined course content [26]. The sixth distinctive feature is that patients learn general applicable goal management competencies that are not disease or problem specific, but can be used in daily life for various difficult situations. Acquiring these goal management competencies aptly complements the health promotion tradition as these competencies assist people in the choice of behaviors that sustain and enhance quality of life within the context of living with a chronic disease [2]. Also, as the focus is on using the existing possibilities and social network of a person and one’s own abilities to solve problems, the goal management intervention will promote resilience. Although the intervention described in this article is, in the first instance, developed for people with polyarthritis, due to all the intervention’s key features, it can easily be adapted for other chronic diseases or disabilities.

The intervention was developed based on theories of goal management. Having and striving for personal goals can give structure and meaning to life and keep a person engaged in meaningful activities [35, 36]. Striving for personal goals may, however, also produce negative psychological effects when people are unable to progress to a desired goal [37, 38]. Goal management strategies (possible ways to react to difficulties along the path towards a goal) are intended to minimize discrepancies between the actual situation and the goals a person has [12]. The Integrated Model of Goal Management [12] combines strategies from two different theories, namely the dual process model of assimilative and accommodative coping [39‐41] and the Goal adjustment model [42]. The resulting four goal management strategies can be applied in different situations. Firstly, the strategy goal maintenance which implies active attempts to alter unsatisfactory life circumstances and situational constraints in accordance with personal preferences [40]. Secondly, the strategy goal adjustment is an approach to adjust personal goals to the personal limit of what remains possible when facing difficulties on the path to a goal [40]. Goal adjustment is the revision of self-evaluative standards and personal goals in accordance with perceived deficits and losses. Thirdly, the strategy goal disengagement is theorized to be one of the poles of the continuum of goal adjustment, as disengagement is an ultimate form of adjusting goals, namely, letting go of goals. Goal disengagement is applied when goals are experienced as no longer attainable [35, 42]. This strategy implies the withdrawing of effort and commitment from an unattainable goal, having the benefit of releasing limited resources that can be deployed for engaging in new goals and alternative goals. Finally, the strategy goal reengagement implies identifying, committing to and starting to pursue new goals [42]. New goals can fill the space created by the release of unattainable goals.

For patients with polyarthritis, maintaining one’s life goals from before disease onset is often impossible [43]. The term polyarthritis is used to indicate a variety of disorders, including rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. People with polyarthritis generally experience inflammation and swelling in joints, and despite improved medical treatment in the last decades, persisting pain, fatigue, disability, deformity, distress and reduced quality of life are daily stressors that patients have to cope with [44, 45]. As a consequence, patients often face difficulties with attaining or maintaining goals in several domains of life, including work, social relationships, leisure activities and domestic tasks [46, 47]. The loss of valued life activities, in particular declines in the ability to perform recreational activities and engage in social interactions, is found to be a predictor of the development of depressive symptoms [48].

Both striving for goals (the strategies of goal maintenance and goal reengagement), as well as accepting a given situation and the scaling down of goals (goal disengagement and goal adjustment) are of great value for adaptation. A previous study indicates that the tendency to use these strategies is associated with adaptation to arthritis [12]. Especially for people with inflammatory arthritis, who must deal with the disease’s unpredictable and fluctuating course, being able to use different approaches across situations can be beneficial [49]. An intervention based on the flexible use of goal management strategies could be promising as it can teach persons to respond to the demands of any situation in an appropriate way. The ability to use a variety of strategies across different situations is denoted by coping flexibility [50]. Despite its possible benefits for adjustment, coping flexibility is rarely studied in the context of chronic disease [51]. One study showed that an increase in coping flexibility was associated with a decreased depressed mood in patients with arthritis [52].

For methodological reasons we have chosen one primary outcome and several secondary outcomes. Because of its comparability with other research, depressive symptoms are the main focus in this study. Firstly, depression in patients with arthritis is a well-researched and documented phenomenon [48, 53‐55]. The second reason is that most research on goal management in other patient groups also focused on depression as (one of the) main outcome measure(s) [41, 56‐58]. Our main hypothesis is that the goal management intervention leads to a significant reduction of depressive symptoms in polyarthritis patients compared to the control condition. In addition, we hypothesize a significant reduction in anxiety symptoms, and a significant improvement in positive affect, purpose in life and satisfaction with participation in patients receiving the intervention as compared to the control condition. We further explore the effect of the intervention on the disease-related outcomes of pain, fatigue and physical functioning.

Moreover, we hypothesize that the ability to use all four goal management strategies and to choose between them depending on the situation mediates the intervention’s effect on depression. Goal management competencies are also hypothesized to mediate the intervention’s effect on the secondary outcomes of anxiety, positive affect, purpose in life and satisfaction with participation. Traditionally, self-efficacy for coping with disease symptoms is found to be correlated with the effect of disease-specific self-management interventions for arthritis patients [30]. Although the goal management intervention is not explicitly designed to increase self-efficacy, we plan to study self-efficacy as an additional putative mediator on the primary and secondary outcomes. Finally, the cost-effectiveness of the intervention is analyzed in terms of medical and non-medical costs. It is conceivable that, in the long run, non-medical costs might decrease because of more realistic planning behavior and decreased absenteeism from work. Additionally, a stakeholders’ analysis of the goal management intervention is executed in order to support and promote future implementation.

The study has been approved by the medical ethics committee Twente, number NL40257.044.12. Participants are recruited via arthritis clinics in four general hospitals in The Netherlands, located in the East and Southeast areas of the country. Moreover, people from existing databases of research participants are invited to participate. Also local newspapers and contacts with patient organizations are used to reach potential participants. The process for obtaining participant informed consent is in accordance with all applicable regulatory requirements.

The research population consists of people with polyarthritis (as defined by the DBC classification system) with a psychological risk profile. The specific inclusion criteria are: 1) age of 18 years or over, 2) diagnosis of polyarthritis, and 3) score of four or higher on the depression subscale of the Hospital Anxiety and Depression Scale (HADS). People with severe distress are excluded and the treating rheumatologist is informed. Severe distress is measured as a total score on the HADS (the total of both the depression and anxiety subscales) of 22 or higher. The cut-off score is based on literature [59, 60]. In addition, insufficient Dutch language skills and actual enrolment in psychotherapeutic treatment at the moment of study are exclusion criteria.

The participants are assigned in a 1:1 ratio to either the experimental group or the control group. Patient allocation is be done by means of blocked stratified randomisation per site in random block sizes of 2 and 4 to make sure that both conditions are equally distributed in each participating hospital. The study is open label, as it is impossible, due to the nature of the program, to blind the staff and participants involved to the condition which the patient is allocated.

The program consists of six group-based meetings with 8 to 10 participants and individual homework assignments. “Doelbewust!” is a protocol-based psychosocial educational program. Doelbewust is the Dutch word for “purposefully” and we have translated this program name into English as “Right On Target”. The program is led by a trained nurse. Participants are introduced to different goal management strategies and learn to use these strategies to cope in a flexible way with threatened personal goals. The goal management strategies that are covered in the program are: goal maintenance, goal adjustment, goal disengagement, and goal reengagement [39‐42].

Table 2 lists the topics, goals, and applied techniques for each meeting of the program. The general structure of each meeting is as follows: a short review of the contents of the previous meeting; introducing the topics of the current meeting; elaborating the topics by group discussions and by practicing in individual, dual and group exercises; and explaining homework assignments for the next meeting. A pilot was executed to test the feasibility of the program protocol.

Participants in the waiting list condition do not receive the “Right On Target” program immediately. Eight months after entry into the study, which is directly after the last follow-up measurement, participants on the waiting list are invited to follow the program.

Table 3 gives an overview of the properties of the measurement instruments used. Participants are asked to complete six questionnaires including: intake, baseline (T0), directly after the end of the program (T1), 2 months after the end of the program (T2), 4 months after the end of the program (T3), and 6 months after the end of the program (T4). Nearly all the instruments listed in Table 3 were applied in a previous study with polyarthritis patients [12], and, when available, Cronbach’s alphas from that previous study also appear in Table 3.

To measure the use of goal management strategies, we use three generic disease questionnaires, and one disease-specific instrument especially designed to measure goal management in arthritis patients.

A brief questionnaire about the general evaluation of the session, the content, material, exercises and the presentation of the trainer is completed by the participants after each session. The trainers also fill in a short evaluation form at the end of each session and a comprehensive evaluation sheet at the end of each program.

During the first two courses, the trainers receive one-hour supervision after every session, and afterwards supervision occurs less frequently, but on a regular basis. Random sessions are recorded with a voice recorder and checked for correct delivery of the protocol.

At the end of a program, two participants per group are randomly chosen and interviewed to evaluate the program with the use of a structured interview scheme. At the end of the study, all the trainers and one person of the management team of the participating clinics are asked during a structured interview to evaluate the program and give suggestions for implementation.

To the best of our knowledge “Right On Target” is the first program that focuses on the four goal management strategies of goal maintenance, goal adjustment, goal disengagement and goal reengagement to support improvement of adaptation to a chronic disease. The possibility to tailor the program to the personal needs of participants is expected to increase its effectiveness and participants’ commitment to the program.

We provided a detailed description of the ingredients of the intervention, in accordance with the argument of Michie et al. [61], in order to communicate applied techniques that support the development of effective interventions and to improve knowledge regarding effective behavior change techniques. We hope to be able to identify the active ingredients in our intervention by clearly stating the underlying theory and assumed mechanisms of behavioral change.

Furthermore, the present study incorporates a holistic focus on adaptation, as the outcomes assessed are both the absence of psychological distress and the presence of well-being. Hence, this research focuses not only on the difficulties that people may experience due to a chronic disease, but also on personal sources of resilience.

As stated earlier in this paper, the goal management program focuses on dealing with threatened personal goals, rather than a pre-defined focus on disease-related goals. This program may ask for different competencies than health professionals are used to deploying in their daily practice. The specialized nurses in rheumatology care who provide the program have undergone extensive training. During the study period, the nurses receive regular guidance and supervision. Nevertheless, it is possible that nurses find it difficult to “sit on their hands” and not provide immediate solutions. This program might be less suitable without the extensive training and guidance of the nurses.

Our study will hopefully answer questions regarding the effectiveness of the goal management intervention for patients with a rheumatic disease. We try to understand the pathways that are responsible for successful adaptation in persons dealing with a rheumatic disease and investigate who benefits most. In addition, we have included an economic evaluation. However, these additional analyzes cannot be conducted in absence of an effect of the goal management intervention compared to the waiting list group.

As the “Right On Target” program is a newly developed intervention, we execute a stakeholders’ analysis. Experiences of participants, trainers and the management of the participating clinics provides insight into the feasibility regarding the intervention. The information from the stakeholders’ analysis supports future implementation of the intervention.