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Interactive Sections of an Internet-Based Intervention Increase Empowerment of Chronic Back Pain Patients: Randomized Controlled Trial
1Institute of Communication and Health, Università della Svizzera italiana, Lugano, Switzerland
2Università degli Studi di Milano, Department of Health Sciences, Milan, Italy
Silvia Riva, PhD
Institute of Communication and Health
Università della Svizzera italiana
Via Buffi 6
Phone: 41 58 666 44 88
Fax: 41 58 666 46 47
Background: Chronic back pain (CBP) represents a significant public health problem. As one of the most common causes of disability and sick leave, there is a need to develop cost-effective ways, such as Internet-based interventions, to help empower patients to manage their disease. Research has provided evidence for the effectiveness of Internet-based interventions in many fields, but it has paid little attention to the reasons why they are effective.
Objective: This study aims to assess the impact of interactive sections of an Internet-based self-management intervention on patient empowerment, their management of the disease, and, ultimately, health outcomes.
Methods: A total of 51 patients were recruited through their health care providers and randomly assigned to either an experimental group with full access to the Internet-based intervention or a control group that was denied access to the interactive sections and knew nothing thereof. The intervention took 8 weeks. A baseline, a mid-term after 4 weeks, and a final assessment after 8 weeks measured patient empowerment, physical exercise, medication misuse, and pain burden.
Results: All patients completed the study. Overall, the intervention had a moderate effect (F1.52=2.83, P=.03, η2=0.30, d=0.55). Compared to the control group, the availability of interactive sections significantly increased patient empowerment (midterm assessment: mean difference=+1.2, P=.03, d=0.63; final assessment: mean difference=+0.8, P=.09, d=0.44) and reduced medication misuse (midterm assessment: mean difference=−1.5, P=.04, d=0.28; final assessment: mean difference=−1.6, P=.03, d=−0.55) in the intervention group. Both the frequency of physical exercise and pain burden decreased, but to equal measures in both groups.
Conclusions: Results suggest that interactive sections as part of Internet-based interventions can positively alter patients’ feelings of empowerment and help prevent medication misuse. Detrimental effects were not observed.
Trial Registration: ClinicalTrials.gov: NCT02114788; http://www.clinicaltrials.gov/ct2/show/NCT02114788 (Archived by WebCite at http://www.webcitation.org/6ROXYVoPR).
(J Med Internet Res 2014;16(8):e180)
Internet-based intervention; interactivity; patient empowerment; chronic back pain; health outcomes; decision; health; physical activity; pain burden; medication misuse; gamification
Chronic Back Pain
Chronic back pain (CBP) is one of the most highly prevalent medical conditions and represents a significant public health problem. It is the second most common pain after headache and it has been identified recently as the single most important among the principal causal factors of years lived with disability worldwide . As recently evaluated by Dunn et al , CBP is often described as a persistent condition with more than one-third of patients suffering for more than 3 years and restricting the daily activities of approximately one-third of the population annually. It is one of the most common symptomatic reasons people seek health care . The costs of CBP in the European Union are considerable and have been estimated to exceed €12 billion each year . As one of the most common causes of disability and sick leave, there is a need to develop new and cost-effective ways to manage the condition [2,3].
One such way is through Internet-based interventions. They can play an important and compensatory role in helping CBP patients to develop appropriate self-management attitudes and strategies. In recent years, the Internet has become a prolific source for health information . Today, there are hundreds, if not thousands, of health-related Internet intervention websites. In many cases, they have become a source of support for people with similar health conditions. In particular, these online programs can improve users’ knowledge and perceived social support, and can therefore have a positive impact on health attitudes and the behavior of people affected by chronic conditions [5-8].
In the last 15 years, the effectiveness of Internet-based interventions has been investigated in many different chronic conditions such as headache, panic disorder, cancer, eating disorders, and, more recently, fibromyalgia and back pain [4-10]. The results of these studies are promising and indicate that Internet-based interventions are effective in improving self-management skills and self-help capabilities, and they represent a cost-effective alternative to traditional health care services . The effectiveness of Internet-based interventions is now well documented by several reviews and meta-analyses [11-17].
Despite the positive outcomes of these interventions, research has also identified some limitations of assessments of Internet-based interventions [16,17]. From a methodological point of view, some findings from previous studies have been interpreted as equivocal because they did not respond to the scientific criteria of clinical trials. Most of the studies were observational, not controlled, and carried out with specific cohorts of participants [4,9]. Other studies failed to describe randomization adequately or to blind patients to the treatment group they belonged to [4,9].
From a theoretical point of view, many studies on Internet-based interventions have tried to answer the question of whether they were effective without investigating how this effect came about . This means many interventions were treated as a “black box”, without any noticeable focus on the different functions and components of their application. In order to understand how an intervention can be effective, the effective elements of interventions can be identified by appropriate experimental research. The design for that is straightforward: one group is given access to elements of which the effectiveness is to be studied while a control group is denied that access. The differences in measured effects can be clearly attributed to the elements under study.
Interactivity in Internet-Based Interventions
In the context of Internet-based interventions, a variable to be considered for such research is one of the major features of the Internet—its potential for interactivity . There are two elements that constitute interactivity. As Sundar claimed: “One of the simplest ways to conceptualize interactivity is as a feature of the medium, specifically the variety of modalities that it offers for the user to experience the various parts of a website, from simple text to graphics, animation, audio and video” . This variety of modalities enriches the speed, the range, and the mapping of the information, which are the three defining elements of interactivity according to Steuer . Speed refers to “the rate at which input can be assimilated into the mediated environment”, range refers to “the number of possibilities for action at any given time”, and mapping refers to “the ability of a system to map its controls to changes in the mediated environment in a natural and predictable manner” . The other element of interactivity is the potential for exchange. That means users cannot only choose what they get from the intervention and how they get it, they also have a chance to talk back to the medium and be talked back to in return. That is, they can ask questions and get tailored answers, they can answer questions others ask them, they can post their experience and receive reactions, and they can react to other people’s experiences .
Interactivity can positively affect patient empowerment . Patient empowerment is defined as a complex construct that includes different individual competencies and skills. According to Perkins and Zimmerman , empowerment goes beyond self-esteem, self-efficacy, competency, locus of control, and other traditional psychological constructs and can be considered a multilevel and multidimensional construct [24-26] closely linked to self-determination [27,28] and self-efficacy [29,30]. Moving from these considerations and favoring a psychological perspective, Thomas and Velthouse  proposed a cognitive model of empowerment, defined as increased intrinsic task motivation, where task motivation involves positively valued experiences that individuals derive directly from a task. In this respect, empowerment “can refer to feelings of power, control, and self-esteem that lead the patient to value autonomy—and thus interest in and desire to participate in health care decisions. This makes empowerment and its dimensions motivational constructs, and empowerment can be called volitional in this vein” [32,33]. Although evidence for the linkage between interactivity and patient empowerment is scarce [19,34], the former is said to enhance the latter because it helps individuals to be active, stimulates a positive attitude to learning, and enhances the value of autonomy [35-37]. Being a motivational construct, patient empowerment is considered a predictor of self-management behaviors, which ultimately affect the health of chronically ill patients .
Interactivity affects not only empowerment. Self-management behaviors as well as patients’ health status are also deemed to be impacted by Internet-based interventions, especially its interactive features [39-41]. If good self-managers in reality are better able to cope with CBP, this experience should be discernable in the stories and experiences related on the interactive sections of the website . A person using these sections should therefore be likely to find examples of how self-management helps other patients cope with the condition. Such positive examples should lead to the conclusion that one’s own methods of self-management could be helpful in coping with the condition. This in turn should reinforce the impression that it is important what one can do to better cope and should thus, on a more general level, reinforce the impression one has of one’s own empowerment in dealing with the disease. Therefore, the interactive elements in health care websites can be expected to augment health self-management.
Other outcomes that may be influenced by Internet-based interventions, particularly the interactive sections on these interventions, include physical exercise and medication adherence [40,41]. Physical exercise is generally recommended for effectively reducing or better coping with CBP  and is therefore the major device for self-management and, as such, a prime target of Internet-based interventions. Medication adherence (in other words, reduced medication misuse) is equally important with respect to reducing back pain without putting one’s life at risk.
The ONESELF Website
This study focuses on the evaluation of a specific Internet based-intervention and its interactive features called ONESELF . The website was first implemented in 2008 to support finding information and learning how to manage CBP and, since 2009, fibromyalgia. Research has shown that the website, which is available in Italian, was by and large successful [19,34,41,43]. It was developed by the Institute of Communication and Health of the Università della Svizzera italiana (Switzerland) in collaboration with a team of rheumatologists and physiotherapists. The health team produced the medical contents and was available to interact with subscribed patients. Communication experts reframed the contents, making them comprehensible for the general public. The website was re-launched in 2013 with a completely new interface and a widening of its scope to include rheumatic arthritis.
For this study, a modified version of the original website was created, restricting access to content on CBP only. A choice of static features including the Library, the First Aid section, and a Frequently Asked Questions (FAQ) section as well as interactive features including the Virtual Gym and the Testimonials and Commentaries sections were maintained from the ONESELF website (for a detailed description, see [19,34,41,43]). In addition, two interactive features were newly developed and implemented: a weekly Action Plan and a Quiz Game. The weekly Action Plan required patients to select at the beginning of each week from a predefined list one or more physical activities of varying intensity to be completed during the week. Reminder short message service (SMS) supported patients in complying with the plan. This feature was added based on insights into its effectiveness on chronic disease management from previous online and offline interventions [44-46]. The Quiz Game was an online examination test that allowed patients to test the information learned during navigation of the website. Patients received a multiple choice question at the end of each visited section. For every correct answer, patients earned virtual points. The sum of these points was used to classify patients in a ranking that was available to all study participants of the intervention group so that patients could see how they scored in comparison to others. This form of interactivity through feedback was proposed in the context of gamification, with the aim of using game thinking and game mechanics in non-game contexts to engage users in improving knowledge on CBP and patient empowerment . Screenshots of the modified ONESELF website are available in Multimedia Appendix 1.
The aim of the present randomized controlled study is to understand not only whether Internet-based interventions like ONESELF can impact patient empowerment, self-management behaviors, and, ultimately, the health status of CBP patients, but also how this can be achieved through interactive features. Thus, we propose two major hypotheses pertaining to the four desirable outcomes: patient empowerment, patients’ improvement of self-management in terms of increased physical exercise and reduced medication misuse, and lower pain burden. These outcomes will improve in CBP patients over the course of the Internet-based intervention—Hypothesis 1 (H1): there will be improvement at the time of the midterm assessment over the baseline assessment and improvement at the time of the final assessment again over the baseline assessment; and Hypothesis 2 (H2): the improvement in the desirable outcomes (empowerment and physical exercise) as well as the decrease in the undesirable outcomes (medication misuse, pain burden) will be larger for CBP patients with access to the interactive sections than for patients denied this access.
To investigate the effect of interactivity, a randomized parallel controlled study was designed (NCT02114788). Two different versions of the modified website were created, one containing only static features (ie, Library, First Aid, and FAQ) and the other containing both static and interactive features (ie, Virtual Gym, Action Plan, Testimonials and Commentaries, and Quiz Game; see Figure 1 for home page). For the intervention group, however, access to the complete version was not granted from the beginning as interactive features were added consecutively week by week as shown in Figure 2. This way, patients in the intervention group had the opportunity to become gradually familiar with the interactive features and to focus week by week on specific content and activities. Patients were blinded to the arm to which they were randomized.