Evaluation of the efficacy of an educational program for rheumatoid arthritis patients

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1 Evaluation of the efficacy of an educational program for rheumatoid arthritis patients B.E. Lovisi Neto, F. Jennings, C. Barros Ohashi, P.G. Silva, J. Natour Division of Rheumatology, Federal University of São Paulo (UNIFESP), São Paulo, SP, Brazil. Abstract Objective To evaluate the efficacy of an educational program for patients with rheumatoid arthritis in relation to their knowledge about the disease and to their psychosocial and physical health status. Materials and methods The study included patients with rheumatoid arthritis classified according to the American College of Rheumatology criteria without any previous participation in disease-specific educational programs. The patients were randomly assigned to an educational program intervention or a waiting list. The intervention was a 6-week educational program consisting of weekly sessions lasting 1 hour each. Evaluations by a blind assessor were made prior to intervention and after 45, 90 and 180 days. The main outcome variables were the Patient Knowledge Questionnaire and the Short-form Health Survey (SF-36) quality of life questionnaire. Secondary outcome variables were the Health Assessment Questionnaire, Visual Analogue Pain Scale, Beck Depression Inventory and State-Trait Anxiety Inventory. Results Patients in the intervention group (n=28) had significant improvement in disease-specific knowledge compared to patients in control group (n=30). There was no significant difference between the groups in terms of pain, depression, anxiety or functional capacity, but the general health perception subscale of SF-36 showed a significant improvement in the intervention group (p=0.041). There was a positive correlation between improvement of disease-specific knowledge and schooling. Conclusions Patients who attended the educational program had significant improvement in disease-specific knowledge and general health perception. No harmful effects on their psychosocial status were noticed. The acquisition of knowledge was also found to be proportional to schooling. Key words Patient education, rheumatoid arthritis, knowledge, quality of life. Clinical and Experimental Rheumatology 2009; 27:

2 Bianca Emilia Lovisi, MD, Rheumatologist Fábio Jennings, MD, Rheumatologist Cláudia Barros Ohashi, MD, Rheumatologist Jamil Natour, MD, Rheumatologist Paula Gabriel Silva, Occupational Therapist Please address correspondence and reprint requests to: Jamil Natour, MD, Division of Rheumatology, UNIFESP, Rua Botucatu 740, São Paulo-SP, Brazil. Received on August 17, 2007; accepted in revised form on June 13, Copyright CLINICAL AND EXPERIMENTAL RHEUMATOLOGY Competing interests: none declared. Introduction Rheumatoid arthritis (RA) is a chronic, progressive disease leading to the loss of functional capacity and, consequently, to social and emotional impairment (1). As with other chronic diseases, there is no curative treatment for rheumatoid arthritis and the course of the disease is often unpredictable. Therefore, educational programs have become an effective complement to traditional medical treatment, providing coping strategies and tools to empower patients to make daily decisions (2). Patient education means any set of planned educational activities designed to improve healthy behavior, and through this, health status and ultimately long-term outcome. An educational program on rheumatic diseases should include comprehensive information about the condition, with all facts presented in a balanced and honest way, in order to reassure patients and support them in their communication with health providers (3). Patient education should lead not only to changes in disease-specific knowledge, but also to changes in behavior and health status (4). To reach these objectives, it is necessary to evaluate the patients needs and meet them with tailor-made initiatives (5). This means that education should be well planned and carefully conceived and provided, considering that the efficacy of the patient s education is determined by the quality of the planning process (6). The rising interest in education results from studies that indicate that education can really contribute to the health status of patients (2, 7-10). It is a low cost, reproducible intervention, exempt from side effects and well accepted by patients, relatives and health providers. Several centers have integrated this approach in their comprehensive clinical care for arthritis patients (11-16). To perform this study, we developed an educational program for patients with rheumatoid arthritis, using as reference, information from literature coupled with the experience of the Rehabilitation Section of the Rheumatology Division of the Federal University de São Paulo (UNIFESP). The strategy of using educational groups was due to the fact that, besides being a low-cost, reproducible method, such groups afford better patient-educator interaction. The objective of this prospective, controlled, randomized study was to evaluate the efficacy of an educational program for patients with rheumatoid arthritis in relation to their knowledge about the disease and to their psychosocial and physical health status. Materals and methods Patients Sixty-four patients with RA consecutively selected from the rheumatology outpatient clinics of Hospital São Paulo and Hospital Geral de Pirajussara, both belonging to UNIFESP, and of Hospital do Servidor Público Estadual de São Paulo, were invited to participate. Inclusion criteria consisted of a diagnosis of RA according to the American College of Rheumatology (ACR) criteria (17), and an age between 18 and 65 years. Exclusion criterion was any previous participation in disease-specific educational programs. Patients from both genders were enrolled and no distinction based on level of education of was made. Study design A randomized, controlled, assessorblind trial. Patients from the intervention group (IG) attended an educational program, while those from the control group (CG) were put on a waiting list for future participation in the program. The study was approved by the Committee of Medical Ethics in Research. All patients freely agreed to participate in the study and signed an informed consent. Sample size Sample size was calculated using the disease-specific knowledge (PKQ) score as the main parameter. With 64 participants, our study had an 80% power to detect a change in knowledge of 4 points between the two groups and allowing a 20% dropout rate. The significance level was set at 5%. Randomization Patients were selected according to the inclusion/exclusion criteria by a single investigator blinded to allocation. After 29

3 signing the informed consent form, subjects were randomized and allocated to the IG and CG by drawing lots. Folded pieces of paper indicating one of the groups were placed in sealed envelops in a container. Another investigator selected the envelops to determine to which group individual subjects would belong. Intervention The educational program offered comprehensive information about rheumatoid arthritis, as refers to etiology, pathogenesis, clinical presentations and management (drugs, rehabilitation and surgery). The language used was simplified to facilitate the comprehension of all participants. The program consisted of six consecutive weekly meetings, each one lasting one hour. The presentations were coordinated by a rheumatologist and by an occupational therapist specialized in rheumatology. Theoretical information was given with the help of visual aids (transparencies and overhead projection). In all of the meetings, the patients were encouraged to actively participate through questions made by the coordinators. Patients relatives were invited to participate in the program. Evaluations Evaluations were performed before the inclusion of the patients in the study (T0) and after 45 (T45), 90 (T90), and 180 days (T180). The assessor was blinded to patient s status, and all the questionnaires were applied orally, during interviews, to overcome the problem posed by the low schooling level of many patients. Outcome variables Demographic-clinical variables: Data referring to age, sex, race, existence of a caregiver, profession, schooling level, and use of disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and steroids, were collected. Disease-specific knowledge: The Brazilian version of the PKQ (Patient Knowledge Questionnaire), consisting of 16 questions, with 80 possible answers, out of which 30 are correct, was used (18, 19) as a knowledge questionnaire about RA. This questionnaire covers four distinct areas. The initial part of the questionnaire deals with general aspects of rheumatoid arthritis, including information about etiology, symptoms and laboratory exams (PKQ-general). The maximum score in this area is 9. The second component of the PKQ (PKQdrugs) involves the medications used for treatment of RA. Its maximum score is 7. The third component is related to the knowledge about exercises (PKQexercises) and allows for a maximum score of 7. The last component covers advice on joint protection and energy conservation (PKQ-JP/EC). Its maximum score is 7. Pain: Pain was evaluated using the visual analogue scale (VAS), varying from 0 to 10 (20, 21). Disability: We used the Brazilian version of the HAQ (Health Assessment Questionnaire), as a specific measure of health status and functional capacity in daily life activities. The tool consists of 20 questions, with results that vary Table I. Demographic-clinical baseline variables for the two groups. from 0 to 3. The bigger the score, the worse the functional capacity (22). Depression: To evaluate depression, the Beck Depression Inventory, which consists of 21 questions, was used. Its score varies from 0 to 63 and it is proportional to the degree of depression (23). Anxiety: Anxiety was evaluated through the State-Trait Anxiety Inventory. This questionnaire evaluates general (trait) and present (state) anxiety. It varies from 1 to 80 points, being proportional to the degree of anxiety (24). Quality of life: We used a generic questionnaire, the SF-36 (Short-form Health Survey), in its Brazilian version (25). This questionnaire covers eight domains, and its score varies from 0 to 100. An increase in the score is proportional to the improvement in quality of life. Statistical analysis Demographic-clinical features were evaluated by descriptive statistical analysis (mean and confidence interval). Pearson s chi-square and Fisher s tests were used to evaluate the homo- Intervention group Control group p-value (n=28) (n=30) Age (yr) mean (SD) (10.50) (9.52) Sex female 92.9% 83.3% male 7.1% 16.7% Race caucasian 50.0% 46.7% non-caucasian 50.0% 53.3% Presence of caregiver 17.9% 23.3% Disease duration mean (SD) 9.43 (9.10) 9.41 (7.95) Schooling Illiterate 7.1% 6.7% yr 32.1% 50.0% yr 39.3% 33.3% yr 14.3% 6.7% >12 yr 7.1% 3.3% DMARD use (*) 92.9% 96.7% NSAID use (**) 46.4% 46.7% Steroid use 71.4% 66.7% *DMARD: disease-modifying anti-rheumatic drugs - methotrexate, chloroquine, leflunomide or sulfasalazine. **NSAID: non-steroidal anti-inflammatory drugs 30

4 geneity between the groups in relation to the categorical variables. Student s t-test was used to check the homogeneity between the groups in relation to the numerical variables. We used the ANOVA test with repeated measures to evaluate the numerical variables (EVA, PKQ, HAQ, BECK, IDATE, SF-36) in comparison between groups and follow-up times. The hypothesis t-test for independent samples was used in the comparison of the differences between baseline (T0), 45 days (T45), 90 days (T90), and 180 days (T180), within the same group. We used Spearman s correlation coefficient, in the evaluation of the correlation between knowledge about the disease and other variables (schooling, age and disease duration). For all statistical tests, the level of significance adopted was p<0,05 or 5%. Results Fifty-eight patients finished the study and were included in the statistical analyses: 28 in the intervention group and 30 in the control group. Four patients in the IG and two controls were lost to follow-up. In these cases, the reason for the incomplete follow-up was noncompliance or failure to complete all the assessments. The groups were homogeneous in relation to all variables at baseline. Both groups were similar regarding demographic characteristics, disease duration, level of education and medication (DMARD, NSAID and corticosteroids) (Table I). Both groups were also considered homogeneous regarding the baseline values obtained in the assessment tests. Tables II and III display the assessment results at the four different time points. Regarding disease-specific knowledge measured by PKQ, a significant improvement was observed in the IG as compared to the CG through the different follow up times (p<0.001). The mean VAS score for pain had baseline values of 6.11 and 6.37 cm in the IG and CG, respectively. These results were maintained in both groups and no statistically significant difference (p=0.555) was observed. Results obtained from HAQ revealed no significant difference Table II. Baseline, 45, 90 and 180 days scores for outcome variables (mean and confidence interval). Comparison between IG and CG. between groups (p=0.913). Similar results were obtained regarding depression as measured by Beck Depression Inventory (p=0.114). No statistically significant difference was observed between the groups regarding either traits (p=0.058) or state of anxiety (p=0.822) (Table II). In the SF-36 domains, functional capacity, physical features, pain, vitality, social features, emotional features, and mental health revealed no statistically significant variations between groups. However, in the general health domain, a significant improvement was observed in the IG as compared to the control group (p=0.041) (Table III). The knowledge questionnaire (PKQ) was also analysed separately, in its four Intervention Group Control Group P (group) mean (95% CI)) mean ( 95% CI)) PKQ <0.001** T ( ) 8.73 ( ) T ( ) 9.57 ( ) T ( ) ( ) T ( ) 9.53 ( ) VAS T ( ) 6.37 ( ) T ( ) 5.63 ( ) T ( ) 5.20 ( ) T ( ) 5.23 ( ) HAQ T ( ) 1,28 ( ) T ( ) 1.20( ) T ( ) 0.98 ( ) T ( ) 1.09 ( ) Beck Depression T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Anxiety trait T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Anxiety state T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) T0: baseline; T45: 45 days; T90: 90 days; T180: 180 days; CI: confidence interval; VAS: visual analogue scale; PKQ: Patient Knowledge Questionnaire; HAQ: Health Assessment Questionnaire; Beck: Beck Depression Inventory; Anxiety-trait: Trait-Anxiety Inventory; Anxiety-state: State-Anxiety Inventory. ANOVA test between groups and follow-up times. *p<0.05. **p <0.001 areas (Table IV). The groups were similar at baseline. However, the IG showed higher scores in all four areas at the follow-up times in relation to CG. A correlation of the PKQ scores with the variables schooling, age and disease duration was performed through the Spearman s linear correlation coefficient. The PKQ in the IG did not show any correlation between baseline (T0) and schooling. In the evaluations made after the educational program, at follow-up times (T45, T90 and T180), a positive correlation was found (Table V). In the CG, a correlation between schooling and the PKQ was not demonstrated. A correlation between schooling and the variables age and disease duration was not found either. 31

5 Table III. Short-form Health Survey (SF36)-domains. Comparison between IG and CG. Discussion This study evaluated the effects of an educational program for patients with rheumatoid arthritis. The most pronounced effect was a considerable increase in knowledge about the disease. Although all the patients were followed by rheumatologists, and several were referred to physical and occupational therapy, initial knowledge about RA was not found to be enough. Researchers state that although disease-specific education cannot assure Intervention group Control group p (group) mean (95% CI) mean (95% CI) Functional capacity T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Physical features T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Pain T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) General health 0.041* T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Vitality T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Social features T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Emotional features T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) Mental health T ( ) ( ) T ( ) ( ) T ( ) ( ) T ( ) ( ) T0: baseline; T45: 45 days; T90: 90 days; T180: 180 days; P (group): shows differences between groups regardless of time; p (time): shows differences between follow-up times within groups. ANOVA test between groups and follow-up times. *p<0.05 compliance with treatment (25), it is evident that patients with insufficient knowledge cannot participate intelligently in their own care (27, 28). The patients in the IG showed a significant increase in the PKQ score after participation in the educational program, and this improvement still held true during follow-up. We found a few studies in the literature in which knowledge about the disease was an outcome variable, and in all of them an improvement was noticed after an educational program was carried out (29-32). In the Helliwell et al. study, the authors also used the PKQ as an instrument for the evaluation of knowledge about RA. (32). HILL et al. (33) used the PKQ, among other tools, to compare patients treated by rheumatologists only, with patients receiving medical care and also followed by nurses specialized in rheumatology. The authors noticed a statistically significant improvement in knowledge about the disease, besides other variables, in the latter group. It must be said that in the group followed by nurses, education was individualized, while in the group treated only by rheumatologists, patients received publications issued by the Arthritis Rheumatism Council and leaflets with information about the drugs used. Although the individual approach is probably more effective, it is more costly, which can make its routine use impossible (3). Concerning knowledge on each component of the PKQ, we noticed a major index of right answers in the PKQ-exercises (37.4%), followed by the PKQ-general (32%) and the PKQdrugs (31.7%). The lowest scores were observed in the PKQ-JP/EC (28.8%). These indices were obtained analyzing the initial means of all participants, regardless of the group, in relation to the score of that component. Jennings et al. (19) showed in their results, bigger knowledge in the component PKQ-exercises and lower scores in the PKQ- JP/EC. Even though the performance was concordant, the aforementioned authors observed higher means in all components of the questionnaire, when compared to the means obtained by the participants of our study. In our study, we did not demonstrate any correlation between knowledge and the variables age and disease duration. A positive correlation was found between the variables schooling and knowledge about the disease, in the IG, after the conclusion of the program. This demonstrates that with individuals attending the educational program, disease-specific knowledge showed a directly proportional variation to the level of schooling, that is, the more years of study the patient has undergone, the 32

6 Table IV. PKQ-score comparison for each component. greater the gain of knowledge will be. Our study did not notice any improvement in pain. Other studies evaluated pain using the VAS as a tool, and showed results in accordance with ours. These studies were controlled and had an educational program, showing similarities with our research (34, 35). In our research, functional capacity measured through the HAQ did not show any difference between the groups. A lack of effect on the functional capacity evaluated through the HAQ Experimental group Control group p (group) mean (95% CI)) mean (95% CI) PKQ- general <0.001** T ( ) 2.80 ( ) T ( ) 3.17 ( ) T ( ) 3.10 ( ) T ( ) 2.83 ( ) PKQ- drugs <0.001** T ( ) 1.83 ( ) T ( ) 1.90 ( ) T ( ) 2.30 ( ) T ( ) 1.90 ( ) PKQ- exercises 0.018* T ( ) 2.30 ( ) T ( ) 2.53 ( ) T ( ) 2.53 ( ) T ( ) 2.57 ( ) PKQ- JP/EC <0.001** T ( ) 1.77 ( ) T ( ) 2.00 ( ) T ( ) 2.50 ( ) T ( ) 2.33 ( ) T0: baseline; T45: 45 days; T90: 90 days; T180: 180 days; CI: confidence interval; PKQ: Patient Knowledge Questionnaire; JP/EC: joint protection/ energy conservation. ANOVA test between groups and follow-up times. *p<0.05. **p<0.001 Table V. Correlation coefficients between PKQ scores and the variables schooling, age and disease duration. Schooling Age Disease duration Intervention group PKQ T PKQ T * PKQ T * PKQ T * Control group PKQ T PKQ T PKQ T PKQ T PKQ: Patient Knowledge Questionnaire; T0: baseline; T45: 45 days; T90: 90 days; T180: 180 days. *significant correlation on level of 5%. was demonstrated in some controlled studies in which educational programs were used (32, 34, 36, 37). In one study that used an educational program with a multidisciplinary approach, a sustained and significant improvement was noticed in the patients who received the educational intervention (38). Concerning the psychosocial status, we noticed a maintenance of depression levels, evaluated by the Beck Inventory; of anxiety levels, evaluated by the Anxiety inventory; and of the emotional features as well as mental health, evaluated by SF-36. Only a tendency towards improvement was identified in anxiety (trait) in the IG. As a possible explanation, confrontation with the fact that there is no cure and the uncertainty about the future can lead to persistent depressive symptoms. However, our study did not demonstrate worsening of the psychosocial status. This shows that information about the disease, its treatment and course, provided through an educational program, did not harmfully affect patients with RA, that is, it did not raise their levels of anxiety or depression. In a controlled study (38), the authors noticed a different result with a significant improvement of depression after an educational program that lasted a year. Despite the good result in the initial evaluations, a return to baseline levels, in five years, was observed. In the evaluation of the effects on physical and psychosocial health status, it should be considered that patient education is given in association with traditional medical care. As a consequence, its effects are always supplementary to this care (7). Although compliance with treatment was not focused as an outcome variable in our study, the literature generally reports low compliance rates with drug therapy in RA (39, 40, 41). We believe that even though the use of drugs, specially disease-modifying ones, was high in our sample (94.8%), compliance with treatment may not have been so expressive. The difficulty to get the drugs from the public providers, together with the low income of the participants of our study, may have led to irregular drug use, influencing treatment results. Another reason for the maintenance of the physical and psychosocial health variables after the educational program might have been the short period of follow-up of our study that did not allow enough time to detect differences in variables such as functional capacity. In conclusion, in accordance with literature data, our study shows that the level of disease-specific knowledge rises significantly after the completion of an educational program. Yet, knowledge does not improve psychosocial and physical health when it is not 33

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