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Effectiveness of Serious Gaming During the Multidisciplinary Rehabilitation of Patients With Complex Chronic Pain or Fatigue: Natural Quasi-Experiment.

ABSTRACT: BACKGROUND:Current evidence for the effectiveness of specialist multidisciplinary programs for burdensome chronic pain and functional somatic syndromes drives the effort to improve approaches, strategies, and delivery modes. It remains unknown to what extent and in what respect serious gaming during the regular outpatient rehabilitation can contribute to health outcomes. OBJECTIVE:The objectives of our study were to determine the effect of additional serious gaming on (1) physical and emotional functioning in general; (2) particular outcome domains; and (3) patient global impressions of change, general health, and functioning and to determine (4) the dependency of serious gaming effects on adherence. METHODS:We conducted a naturalistic quasi-experiment using embedded qualitative methods. The intervention group patients received an additional guided (mindfulness-based) serious gaming intervention during weeks 9-12 of a 16-week rehabilitation program at 2 sites of a Dutch rehabilitation clinic. Simultaneously, 119 control group patients followed the same program without serious gaming at 2 similar sites of the same clinic. Data consisted of 10 semistructured patient interviews and routinely collected patient self-reported outcomes. First, multivariate linear mixed modeling was used to simultaneously estimate a group effect on the outcome change between weeks 8 and 16 in 4 primary outcomes: current pain intensity, fatigue, pain catastrophizing, and psychological distress. Second, similar univariate linear mixed models were used to estimate effects on particular (unstandardized) outcomes. Third, secondary outcomes (ie, global impression of change, general health, functioning, and treatment satisfaction) were compared between the groups using independent t tests. Finally, subgroups were established according to the levels of adherence using log data. Influences of observed confounding factors were considered throughout analyses. RESULTS:Of 329 eligible patients, 156 intervention group and 119 control group patients (N=275) with mostly chronic back pain and concomitant psychosocial problems participated in this study. Of all, 119 patients played ?75% of the game. First, the standardized means across the 4 primary outcomes showed a significantly more favorable degree of change during the second part of the treatment for the intervention group than for the control group (beta=-0.119, SE=0.046, P=.009). Second, the intervention group showed a greater outcome change in depressive mood (b=-2.748, SE=1.072, P=.011) but not in "insufficiency" or concentration problems. Third, no significant group effects on secondary outcomes were found. Fourth, adherence was generally high and invariant. CONCLUSIONS:The findings of this study suggest a very small favorable average effect on relevant health outcomes of additional serious gaming during multidisciplinary rehabilitation. The indication that serious gaming could be a relatively time-efficient component warrants further research into if, when, how, and for which patients serious gaming could be cost-effective in treatment and why. TRIAL REGISTRATION:Netherlands Trial Registry NTR6020; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6020 (Archived by WebCite at http://www.webcitation.org/71IIoTXkj).

SUBMITTER: Vugts MA

PROVIDER: S-EPMC6115601 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Effectiveness of Serious Gaming During the Multidisciplinary Rehabilitation of Patients With Complex Chronic Pain or Fatigue: Natural Quasi-Experiment.

Vugts Miel Ap MA Joosen Margot Cw MC Mert Agali A Zedlitz Aglaia Me AM Vrijhoef Hubertus Jm HJ

Journal of medical Internet research 20180815 8

<h4>Background</h4>Current evidence for the effectiveness of specialist multidisciplinary programs for burdensome chronic pain and functional somatic syndromes drives the effort to improve approaches, strategies, and delivery modes. It remains unknown to what extent and in what respect serious gaming during the regular outpatient rehabilitation can contribute to health outcomes.<h4>Objective</h4>The objectives of our study were to determine the effect of additional serious gaming on (1) physical ...[more]

PMID: 30111527

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Project description:BACKGROUND:Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. OBJECTIVE:To realize this potential, insight is needed into how, why, for whom, and when it works in actual treatment circumstances. METHODS:Following a realist approach, process evaluations were performed before, during, and after a two-armed, natural quasi-experiment (n=275). A group of patients with interfering chronic pain or fatigue symptoms received a short additional blended mindfulness-based serious gaming intervention during a multidisciplinary rehabilitation program. A control group only received the regular rehabilitation program. During two sessions before and one session after the experiment, expectations about serious gaming processes were discussed in focus groups with local care providers, implementers, and experts. Patients participated in a survey (n=114) and in semistructured interviews (n=10). The qualitative data were used to develop tentative expectations about aspects of serious gaming that, in certain patients and circumstances, trigger mechanisms of learning and health outcome change. Hypotheses about indicative quantitative data patterns for tentative expectations were formulated before inspecting, describing, and analyzing-with regression models-routinely collected clinical outcome data. An updated program theory was formulated after mixing the qualitative and quantitative results. RESULTS:Qualitative data showed that a subset of patients perceived improvement of their self-awareness in moments of daily social interactions. These results were explained by patients, who played the serious game LAKA, as a "confrontation with yourself," which reflected self-discrepancies. Important characteristics of serious gaming in the study's context included innovation factors of relative advantage with experiential learning opportunity, compatibility with the treatment approach, and the limited flexibility in regard to patient preferences. Perceived patient factors included age and style of coping with stress or pain. Learning perceptions could also depend on care provider role-taking and the planning and facilitating (ie, local organization) of serious gaming introduction and feedback sessions in small groups of patients. Quantitative data showed very small average differences between the study groups in self-reported depression, pain, and fatigue changes (-.07<beta<-.17, all 95% CI upper bounds <0), which were mediated by small group differences in mindfulness (beta=.26, 95% CI .02-.51). Mindfulness changes were positively associated with patient involvement in serious gaming (n=114, beta=.36, P=.001). Acceptance of serious gaming was lower in older patients. Average health outcome changes went up to a medium size in patients that reported lower active coping with stress and lower pain coping before serious gaming. Mindfulness changes and gaming acceptance perceptions covaried with group structure and immediate feedback sessions after serious gaming. CONCLUSIONS:This study developed transferable insight into how and why serious gaming can facilitate additional learning about coping in order to reduce burdens of chronic pain or fatigue symptoms in certain patients and in actual treatment circumstances. Future studies are needed to continue the development of this fallible theory. Such research will further support decisions about using, designing, allocating, and tailoring serious gaming to optimize important patient health benefits. TRIAL REGISTRATION:Netherlands Trial Register NTR6020; https://www.trialregister.nl/trial/5754.

Project description:INTRODUCTION:Many individuals suffer from chronic pain or functional somatic syndromes and face boundaries for diminishing functional limitations by means of biopsychosocial interventions. Serious gaming could complement multidisciplinary interventions through enjoyment and independent accessibility. A study protocol is presented for studying whether, how, for which patients and under what circumstances, serious gaming improves patient health outcomes during regular multidisciplinary rehabilitation. METHODS AND ANALYSIS:A mixed-methods design is described that prioritises a two-armed naturalistic quasi-experiment. An experimental group is composed of patients who follow serious gaming during an outpatient multidisciplinary programme at two sites of a Dutch rehabilitation centre. Control group patients follow the same programme without serious gaming in two similar sites. Multivariate mixed-modelling analysis is planned for assessing how much variance in 250 patient records of routinely monitored pain intensity, pain coping and cognition, fatigue and psychopathology outcomes is attributable to serious gaming. Embedded qualitative methods include unobtrusive collection and analyses of stakeholder focus group interviews, participant feedback and semistructured patient interviews. Process analyses are carried out by a systematic approach of mixing qualitative and quantitative methods at various stages of the research. ETHICS AND DISSEMINATION:The Ethics Committee of the Tilburg School of Social and Behavioural Sciences approved the research after reviewing the protocol for the protection of patients' interests in conformity to the letter and rationale of the applicable laws and research practice (EC 2016.25t). Findings will be presented in research articles and international scientific conferences. TRIAL REGISTRATION NUMBER:A prospective research protocol for the naturalistic quasi-experimental outcome evaluation was entered in the Dutch trial register (registration number: NTR6020; Pre-results).

Project description:BACKGROUND:to date, there are no medical or surgical treatments for progressive supranuclear palsy (PSP). It is possible to speculate that patients with PSP could benefit from rehabilitative treatments designed for Parkinson's disease, including the use of robot-assisted walking training. OBJECTIVE:to evaluate whether the use of the robotic device Lokomat® is superior in PSP patients to the use of treadmill with visual cues and auditory feedbacks (treadmill-plus) in the context of an aerobic, multidisciplinary, intensive, motor-cognitive and goal-based rehabilitation treatment (MIRT) conceived for Parkinsonian patients. METHODS:we enrolled twenty-four PSP patients. Twelve subjects underwent a 4-week MIRT exploiting the use of the treadmill-plus (MIRT group). Twelve subjects underwent the same treatment, but replacing the treadmill-plus with Lokomat® (MIRT-Lokomat group). Subjects were evaluated with clinical and functional scales at admission and discharge. The primary outcomes were the total PSP Rating Scale (PSPRS) score and its "limb" and "gait" sub-scores. Secondary outcomes were Berg Balance Scale (BBS), Six Minutes Walking test (6MWT) and the number of falls. RESULTS:total PSPRS, PSPRS-gait sub-score, BBS, 6MWT and number of falls improved significantly in both groups (p ? 0.003 all, except 6MWT, p = 0.032 and p = 0.018 in MIRT-Lokomat and MIRT group respectively). The PSPRS-limb sub-score improved significantly only in the MIRT group (p = 0.002). A significant difference between groups was observed only for total PSPRS, indicating a slightly better improvement for patients in the MIRT group (p = 0.047). No differences between groups were revealed for the other outcomes, indicating that the effect of rehabilitation was similar in both groups. CONCLUSIONS:Lokomat® training, in comparison with treadmill-plus training, does not provide further benefits in PSP patients undergoing MIRT. Our findings suggest the usefulness of an aerobic, multidisciplinary, intensive, motor-cognitive and goal-based approach for the rehabilitation of patients suffering from such a complex disease as PSP. TRIAL REGISTRATION:This trial was registered on ClinicalTrials.gov, NCT02109393.

Project description:BackgroundThe long-term effects of behavioural medical rehabilitation (BMR), as a type of multidisciplinary rehabilitation, in the treatment of chronic non-specific low back pain (CLBP) have been shown. However, the specific effects of behavioural exercise therapy (BET) compared to standard exercise therapy (SET) within BMR are not well understood. The aim of the study was to assess the effectiveness of BMR + BET compared to BMR + SET in individuals with CLBP in a two-armed, pre-registered, multicentre, parallel, randomised controlled trial (RCT).MethodsA total of 351 adults with CLBP in two rehabilitation centres were online randomised based on an 'urn randomisation' algorithm to either BMR + SET (n = 175) or BMR + BET (n = 176). Participants in both study groups were non-blinded and received BMR, consisting of an multidisciplinary admission, a psychosocial assessment, multidisciplinary case management, psychological treatment, health education and social counselling. The intervention group (BMR + BET) received a manualised, biopsychosocial BET within BMR. The aim of BET was to develop self-management strategies in coping with CLBP. The control group (BMR + SET) received biomedical SET within BMR with the aim to improve mainly physical fitness. Therapists in both study groups were not blinded. The BMR lasted on average 27 days, and both exercise programmes had a mean duration of 26 h. The primary outcome was functional ability at 12 months. Secondary outcomes were e.g. pain, avoidance-endurance, pain management and physical activity. The analysis was by intention-to-treat, blinded to the study group, and used a linear mixed model.ResultsThere were no between-group differences observed in function at the end of the BMR (mean difference, 0.08; 95% CI - 2.82 to 2.99; p = 0.955), at 6 months (mean difference, - 1.80; 95% CI; - 5.57 to 1.97; p = 0.349) and at 12 months (mean difference, - 1.33; 95% CI - 5.57 to 2.92; p = 0.540). Both study groups improved in the primary outcome and most secondary outcomes at 12 months with small to medium effect sizes.ConclusionBMR + BET was not more effective in improving function and other secondary outcomes in individuals with CLBP compared to BMR + SET.Trial registrationCurrent controlled trials NCT01666639 , 16/08/2012.

Project description:Robust empirical evidence supports the idea that embryonic and, more generally, intrauterine disruptions induced by the 1918-flu pandemic had long-term consequences on adult health status and other conditions. In this paper we assess the 1918-flu long-term effects not just of in utero exposure but also during infancy and early childhood. A unique set of events that took place in Puerto Rico during 1918-1919 generated conditions of a "double quasi-natural experiment". We exploit these conditions to empirically identify effects of exposure to the 1918 flu pandemic and those of the devastation left by an earthquake-tsunami that struck the island in 1918. Because the earthquake-tsunami affected mostly the Western coast of the island whereas early (in utero and postnatal) exposure to the flu was restricted to those born in the interval 1917-1920, we use geographic variation to identify the effects of the quake and timing of birth variation to identify those of the flu. We benefit from availability of information on markers of nutritional status in a nationally representative sample of individuals aged 75 and older in 2002. We make two contributions. First, unlike most fetal-origins research that singles out early nutritional status as a determinant of adult health, we hypothesize that the 1918 flu damaged the nutritional status of adult survivors who, at the time of the flu, were in utero or infants. Second, we target markers of nutritional status largely set when the adult survivors were infants and young children. Estimates of effects of the pandemic are quite large mostly among females and those who were exposed to the earthquake-tsunami. Impacts of the flu in areas less affected by the earthquake are smaller but do vary by area flu severity. These findings constitute empirical evidence supporting the conjecture that effects of the 1918 flu and/or the earthquake are associated not just with disruption experienced during the fetal period but also postnatally.

Dataset Information

Effectiveness of Serious Gaming During the Multidisciplinary Rehabilitation of Patients With Complex Chronic Pain or Fatigue: Natural Quasi-Experiment.

Publications

Effectiveness of Serious Gaming During the Multidisciplinary Rehabilitation of Patients With Complex Chronic Pain or Fatigue: Natural Quasi-Experiment.

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