Effectiveness of a group-based intervention to change medication beliefs and improve medication adherence in patients with rheumatoid arthritis: A randomized controlled trial

Objective

To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA).

Methods

Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up.

Results

123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months’ follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: −1.0 (95% CI: −2.0, −0.1)).

Conclusion

This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time.

Practice implications

Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out.     

A randomized controlled trial of an intervention to reduce low literacy barriers in inflammatory arthritis management

Objective

Test the efficacy of educational interventions to reduce literacy barriers and enhance health outcomes among patients with inflammatory arthritis.

Methods

The intervention consisted of plain language information materials and/or two individualized sessions with an arthritis educator. Randomization was stratified by education level. Principal outcomes included adherence to treatments, self-efficacy, satisfaction with care, and appointment keeping. Secondary outcomes included health status and mental health. Data were collected at baseline, six, and twelve months post.

Results

Of the 127 patients, half had education beyond high school and three quarters had disease duration greater than five years. There were no differences in the primary outcome measures between the groups. In mixed models controlling for baseline score and demographic factors, the intervention group showed improvement in mental health score at six and twelve months (3.0 and 3.7 points, respectively), while the control group showed diminished scores (−4.5 and −2.6 points, respectively) (p = 0.03 and 0.01).

Conclusion

While the intervention appears to have had no effect on primary outcomes, further studies with continued attention to literacy are warranted. Study site and disease duration must be considered as participants in this study had higher than average health literacy and had established diagnoses for years prior to this study.

Practice implications

The study offers insight into an application of many of the protocols currently recommended to ameliorate effects of limited literacy.     

Group education for patients with rheumatoid arthritis

Patients with rheumatoid arthritis must learn to adjust their exercise, rest and medication to the varying activity of the disease. Patient education can help patients in making the right decisions about adjustments in their treatment regimen and in attaining “self-management” behaviors. We developed a group education program based on social learning theory and the ‘Arthritis Self Management Course’ developed in the USA by Lorig. Goal of the program is the strengthening of self-efficacy, outcome expectations and self-management behaviors of RA patients which may lead to better health status. The program has been evaluated in an experimental design. We established significant positive effects of the group training on functional disability, joint tenderness, practice of relaxation and physical exercises, self-management behavior, outcome expectations, self-efficacy function and knowledge. After 14 months we still found effects on practice of physical exercises, self-efficacy function and knowledge.     

Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: A randomized controlled trial

ObjectiveTo evaluate the efficacy of shared decision-making (SDM) intervention among patients with lumbar degenerative diseases (LDDs) in terms of decision self-efficacy, control preferences, SDM process, decision satisfaction, and conflict.MethodsA total of 130 outpatients with LDDs recruited from orthopedic or rehabilitation clinics were randomly assigned to the SDM intervention (n = 67) or comparison (n = 63) groups. Patients in the intervention group received decision aids (DAs) with decision coaching and those in controlled group received standard educational materials from a health educator. The primary outcome was decision self-efficacy, and secondary outcomes were control preference, SDM process, conflict, and satisfaction.ResultsThe SDM intervention significantly improved decision self-efficacy (mean difference [MD] = 7.1, 95% confidence interval [CI]: 1.7–12.5, partial η² = 0.05) and reduced conflict (MD = −7.0, 95% CI: −12.2 to −1.9, partial η² = 0.06), especially in patients without family involvement, compared with the health education group. However, no significant between-group differences were observed in other outcomes.ConclusionSDM intervention improved SDM self-efficacy and reduced conflict in patients with LDDs.Practice ImplicationsClinicians can integrate DAs and decision coaching in SDM conversations. SDM intervention seems to engage patients in decision-making, especially those without family involvement.     

Predictors of refusal during a multi-step recruitment process for a randomized controlled trial of arthritis education

Objective

Randomized controlled trials in patient education often have difficulty enrolling vulnerable populations—specifically, older, poorer, and less educated individuals. We undertook a randomized controlled trial (RCT) of an educational intervention for arthritis management, which included strategies to remove literacy-related barriers to participation. This paper reports on the multi-stage recruitment process and assesses whether refusal to participate was related to education, age, gender, working status, or insurance status.

Methods

The recruitment protocol was designed to eliminate literacy-related barriers to participation. Patients were never asked to read or fill out forms. Interactions were oral, using everyday terms and short, clear sentences. Patients who declined during a screening call were considered Stage 1 Refusers. Patients who initially expressed interest but neither completed a baseline questionnaire nor provided consent were considered Stage 2 Refusers. Patients who consented were considered Enrollees. Age, gender, and insurance status were compared between Stage 1 Refusers and Enrollees. A second analysis compared these variables, plus educational attainment and working status, between Stage 2 Refusers, and Enrollees.

Results

Of 408 eligible patients, there were 193 (47.3%) Stage 1 Refusers, 81 (19.9%) Stage 2 Refusers and 134 (32.8%) Enrollees. A higher proportion of Stage 1 Refusers than Enrollees were ≥65 years old (58% vs. 37%, p = .0003). Multivariate analysis, adjusting for gender and insurance status, confirmed the effect of older age on refusal (OR = 2.3 (1.4, 3.6)). There were no significant differences between Stage 2 Refusers and Enrollees.

Conclusion

We found no evidence of refusal to participate due to educational attainment, working status, insurance status, or gender. Older patients were more likely to refuse participation at the first stage of recruitment.

Practice implications

Researchers should continue efforts to increase participation among older patients, particularly when studies are designed to be generalized to an elderly population as is the case with arthritis research. Strategies used in this recruitment protocol designed to remove literacy-related barriers to recruitment may be responsible for the observation that subjects with lower education did not have a higher rate of refusal. Such strategies deserve further study.     

The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial

Objective

The aim of this study was to investigate the effect of an educational programme for patients with polyarthritis compared to usual care.

Methods

Patients with rheumatoid arthritis, psoriatic arthritis and unspecified polyarthritis were randomised to the intervention (n = 71) or usual care (n = 70). The intervention consisted of three group educational sessions followed by one individual educational session. The primary outcomes were a patient's global well-being and arthritis self-efficacy. Secondary outcomes were patient activation, physical and psychological health status, educational needs and disease activity.

Results

After four months the intervention group had significantly better global well-being, 95% CI (2.3–14.1), p = 0.01, and self-efficacy, 95% CI (0.2–8.1), p = 0.04, than the control group. There were also trends for improved disease activity, and a statistically significant improvement in patient activation and pain in the intervention group.

Conclusion

This patient educational programme consisting of group sessions and nurse-delivered individual education has statistically significant benefits for global well-being and maintaining a level of self-efficacy in managing other symptoms in patients with polyarthritis.

Practice implications

This educational programme allows patients to learn from each other in addition to addressing individual educational needs.     

Translating patient education theory into practice: Developing material to address the cardiovascular education needs of people with rheumatoid arthritis

Objective

This paper describes the rationale and design of a theory-informed patient education programme addressing cardiovascular disease for people with rheumatoid arthritis (RA) to illustrate how theory can explicitly be translated into practice.

Methods

A steering group of rheumatologists and psychologists was convened to design the programme. The Common Sense Model, the Theory of Planned Behaviour and the Stages of Change Model were used to underpin the topics and activities in the programme. User involvement was sought. The programme was formatted into a manual and the reading age of the materials was calculated.

Results

A small group 8-week programme was designed. The structure of the patient education programme, including topics, underlying psychological theory as well as behaviour change techniques, is described.

Conclusion

This patient education programme addresses a currently unmet educational need for patients with RA and uses theory to design, not just evaluate, the programme. This will allow both enhanced interpretation of the results when the programme is implemented and replication by other units if successful.

Practice implications

The actual design and detail of education programmes merit wider dissemination to facilitate progress in the process of development and application.     

Effectiveness of question prompt lists in patients with breast cancer: A randomized controlled trial

ObjectivesTo evaluate the effectiveness of a question prompt list (QPL) in decision self-efficacy, decision-making participation, patient–physician communication, decisional conflict or regret, and health status in patients with breast cancer.MethodsA total of 240 patients with breast cancer were randomly assigned to a QPL group or control group (n = 120 each). The intervention and control groups received an additional educational QPL booklet and routine care, respectively.ResultsThe intervention group exhibited significant improvements in decision self-efficacy, perceived patient–physician interactions, and patient–physician communication compared with the control group. Multilevel modeling analyses revealed significant group–time interaction effects on decision self-efficacy (β = 9.99, P < 0.01), perceived patient–physician interactions (β = 8.10, P < 0.01), patient–physician communication (β = 5.02, P < 0.01), and anxiety status (β = ?3.78, P < 0.05). The QPL intervention exerted more favorable effects than routine care, with repeated measurements of the same patients and the data of patients under the care of the same surgeons accounted for.ConclusionsThe QPL intervention exerted multidimensional effects on decision-making outcomes among patients with breast cancer.Practical implicationsClinicians can integrate a QPL into routine care for patients with breast cancer.     

Development and initial validation of a heart disease knowledge questionnaire for people with rheumatoid arthritis

Objective

To develop and validate two parallel versions of the Heart Disease Fact Questionnaire-Rheumatoid Arthritis (HDFQ-RA), a modified and RA-specific version of the HDFQ.

Methods

The questionnaire was composed of generic questions from the original HDFQ with additional RA-specific questions added. Cognitive interviewing was performed and the questionnaire piloted to generate two parallel questionnaires. For psychometric validation, 130 patients with RA completed the questionnaires at baseline and 2 weeks later.

Results

Parallel form reliability of both questionnaires was established; the median score for both questionnaires was 9/13 with no statistical difference in scores. Kuder–Richardson-20 formula was 0.65 and 0.67 for both questionnaires. Test–retest stability showed constant median scores of 9/13 and no statistical difference in scores between baseline and follow-up. Known groups comparison revealed that patients who had self-educated themselves about heart disease, or who were taking CVD medications, had significantly higher scores on the questionnaires.

Conclusion

The two parallel forms of the HDFQ-RA have been shown to be equivalent measures of CVD knowledge and evidence supporting their reliability and validity is presented.

Practice implications

The HDFQ-RA is an appropriate tool for application in clinical and research settings, e.g., assessing novel educational interventions or tracking participants’ progress on an education course.     

Effect of communicating personalized rheumatoid arthritis risk on concern for developing RA: A randomized controlled trial

Objective

To investigate the effect of providing comprehensive personalized risk information on concern for chronic disease development.

The effects of an integrated health education and exercise program in community-dwelling older adults with hypertension: A randomized controlled trial

Objective

The aim of this study was to examine the effectiveness of HAHA (Healthy Aging and Happy Aging) program, which is an integrated health education and exercise program for community-dwelling older adults with hypertension. Methods: Older adults with hypertension from one senior center were randomly allocated to experimental (n = 18) or control group (n = 22). Experimental group received health education, individual counseling and tailored exercise program for 12 weeks. Results: The mean ages were 71 years (experimental group) and 69 (control group). After the intervention, systolic blood pressure of experimental group was significantly decreased than that of control group. Scores of exercise self-efficacy, general health, vitality, social functioning, and mental health in SF-36 were statistically higher than those of control group. Conclusion: The HAHA program was effective in control of systolic blood pressure and improving self-efficacy for exercise and health-related quality of life.     

The influence of biofeedback training on trapezius activity and rest during occupational computer work: a randomized controlled trial

The aim of this study was to investigate effects of biofeedback training on trapezius activity and rest (gaps) during occupational computer work. A randomized controlled trial with 164 computer workers was performed. Two groups working with computer mouse more than 50% (n = 64) and less than 25% (n = 49) of their work time performed five sessions with unilateral electromyographical (EMG) biofeedback from the dominant trapezius during computer work. A third group working with computer mouse more than 50% of their work time (n = 51) served as controls. Bipolar EMG from the bilateral upper trapezius muscles during normal computer work was recorded. Changes in discomfort/pain were not recorded. The biofeedback training reduced activity (P < 0.05), and increased the frequency of short (P < 0.05) and long (P < 0.05) gaps, and the relative rest time (P < 0.05) of the trapezius during computer work. By improving trapezius inactivity during computer work, biofeedback training may have the potential to prevent trapezius myalgia in computer workers.     

Effects of a short-term occupational therapy intervention in an acute geriatric unit. A randomized clinical trial

Objectives

To compare the benefits of a short-term occupational therapy intervention (OTI) when added to the conventional treatment model (CTM) in the functional recovery of patients admitted to an acute geriatric unit (AGU).

Study design

Non-pharmacological randomized clinical trial. 400 patients were randomized to OTI (n = 198) or CTM (n = 202) group. Mean age 83.5. Interventions included needs assessment, iatrogenic prevention, retraining in activities of daily living, and instructions for caregivers in three groups of patients defined a priori (cardiopulmonary disease, stroke, other conditions) 5 days a week, 30–45 min a day.

Main outcome measure

Recovery of ≥10 Barthel index points by discharge. Secondary outcome was the reduction in confusional episodes.

Results

The adjusted relative risk (RR) of functional recovery in the OTI group was 1.16 (95%CI 0.91–1.47). In participants with cardiopulmonary disease was 1.57 (95%CI 1.06–2.32), number needed to treat (NNT) 5. Participants with other conditions assigned to OTI had a reduction in acute confusional episodes; RR 0.48 (95% CI 0.26–0.87), NNT 7.

Conclusions

Although overall there were no significant differences, patients with cardiopulmonary disease or non-stroke pathologies admitted to an AGU, may benefit from a short-term OTI.     

Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial

Objective

To evaluate the efficacy of ongoing group based diabetes self-management education (DSME) for patients with type 2 diabetes.

Methods

146 patients were randomised to either group education or waiting list control. Primary outcomes were A1C and patient activation measured with patient activation measure (PAM).

Results

There were no differences in the primary outcomes between the groups at 12 months, but the control group had an increase in A1C of 0.3% points during follow-up. Diabetes knowledge and some self-management skills improved significantly in the intervention group compared to the control group. A sub group analysis was conducted for the quartile with the highest A1C at baseline (>7.7, n = 18 in both groups). There were significant improvements within the intervention group at 12 month follow-up for both A1C and PAM and a trend for better outcome in the intervention group compared to the control.

Conclusions

The locally developed ongoing diabetes self-management education programs prevented an increase in A1C and can have an effect on A1C in patients with higher A1C level.

Practice implications

Locally developed programs may be less effective than programs developed for studies.     

Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial

Objective

To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund.

Methods

Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence.

Results

Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p < 0.001).

Conclusion

PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account.

Practice implications

This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.     

What you wear does not affect the credibility of your treatment: A blinded randomized controlled study

ObjectiveProfessional appearance is easily modifiable, and might alter the effects of a clinical encounter. We aimed to determine whether professional attire influences a patient’s perception of treatment credibility.MethodsWe performed a single-blind randomized controlled study on 128 patients with acute non-specific low back pain who were about to receive treatment in primary care. The treating clinician was randomly allocated to wear formal attire (experimental condition) or casual attire (control condition) to the consultation. Clinicians provided a standardized briefing on the rationale behind the patient’s forthcoming treatment. Treatment credibility (Credibility and Expectancy Questionnaire) was assessed immediately after this briefing.ResultsAll patients received the experimental or control condition as allocated and provided complete primary outcome data. Formal attire had no effect on perceived treatment credibility (Mean difference between groups 1.2 [95%CI-1.1 to 3.5]). Age was the only significant predictor of treatment credibility; older patients rated treatment credibility higher (Beta = 0.16 [95%CI 0.08 to 0.24]).ConclusionIn a trial setting, whether or not a clinician is formally dressed has no effect on perceptions of treatment credibility in patients with acute low back pain.Practice implicationClinicians should dress comfortably without fear of losing credibility.     

The effects of two health information texts on patient recognition memory: A randomized controlled trial

Objective

To compare the effects of two health information texts on patient recognition memory, a key aspect of comprehension.

Methods

Randomized controlled trial (N = 60), comparing the effects of experimental and control colorectal cancer (CRC) screening texts on recognition memory, measured using a statement recognition test, accounting for response bias (score range −0.91 to 5.34). The experimental text had a lower Flesch–Kincaid reading grade level (7.4 versus 9.6), was more focused on addressing screening barriers, and employed more comparative tables than the control text.

Results

Recognition memory was higher in the experimental group (2.54 versus 1.09, t = −3.63, P = 0.001), including after adjustment for age, education, and health literacy (β = 0.42, 95% CI: 0.17, 0.68, P = 0.001), and in analyses limited to persons with college degrees (β = 0.52, 95% CI: 0.18, 0.86, P = 0.004) or no self-reported health literacy problems (β = 0.39, 95% CI: 0.07, 0.71, P = 0.02).

Conclusion

An experimental CRC screening text improved recognition memory, including among patients with high education and self-assessed health literacy.

Practice implications

CRC screening texts comparable to our experimental text may be warranted for all screening-eligible patients, if such texts improve screening uptake.     

A randomized controlled trial of estrogen treatment in men with mild cognitive impairment

This randomized, placebo-controlled, cross-over study investigated whether estrogen treatment would have a beneficial effect on tests of verbal memory in men with mild cognitive impairment (MCI). Forty-three men newly diagnosed with MCI were administered a battery of neuropsychological tests before randomly receiving 12 weeks of treatment with estrogen or placebo followed by a 12 week cross-over treatment. A significant improvement in the total score, and in two subscale scores of the Buschke Selective Reminding Test occurred following estrogen treatment compared to both pretreatment and post-placebo scores (p < 0.05). However, benefit occurred only in the men who had received estrogen for 12 weeks following 12 weeks of placebo. Although these findings tentatively suggest that treatment with estrogen may improve verbal memory in men with MCI, the fact that the improvement occurred only in the group that received estrogen following 12 weeks of placebo and the absence of improvement on every test of verbal memory administered suggests that these findings need to be replicated using a larger sample size.     

Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial

Background

Personally controlled health records (PCHRs) are accessible over the Internet and allow individuals to maintain and manage a secure copy of their medical data. These records provide a new opportunity to provide customized health recommendations to individuals based on their record content. Health promotion programs using PCHRs can potentially be used in a variety of settings and target a large range of health issues.

Objectives

The aim was to assess the value of a PCHR in an employee health promotion program for improving knowledge, beliefs, and behavior around influenza prevention.

Methods

We evaluated a PCHR-based employee health promotion program using a randomized controlled trial design. Employees at Hewlett Packard work sites who reported reliable Internet access and email use at least once every 2 days were recruited for participation. PCHRs were provided to all participants for survey administration, and tailored, targeted health messages on influenza illness and prevention were delivered to participants in the intervention group. Participants in the control group received messages addressing cardiovascular health and sun protection. The main outcome measure was improvement in knowledge, beliefs, and behavior around influenza prevention. Secondary outcomes were influenza vaccine rates among household members, the impact of cardiovascular health and sun protection messages on the control group, and the usability and utility of the PCHR-based program for employees.

Results

The intervention did not have a statistically significant effect on the influenza knowledge elements we assessed but did impact certain beliefs surrounding influenza. Participants in the intervention group were more likely to believe that the influenza vaccine was effective (OR = 5.6; 95% CI = 1.7-18.5), that there were actions they could take to prevent the flu (OR = 3.2; 95% CI = 1.1-9.2), and that the influenza vaccine was unlikely to cause a severe reaction (OR = 4.4; 95% CI = 1.3-15.3). Immunization rates did not differ between the intervention and control groups. However, participants in the intervention group were more likely to stay home during an infectious respiratory illness compared with participants in the control group (39% [16/41] vs 14% [5/35], respectively; P = .02). The program also succeeded in improving recognition of the signs of heart attack and stroke among participants in the control group. Overall, 78% of participants rated the PCHR as “extremely/very” easy to use, and 73% responded that they would be “extremely/very” likely to participate again in a PCHR-based health promotion system such as this one.

Conclusions

With a small sample size, this study identified a modest impact of a PCHR-based employee health program on influenza prevention and control. Employees found the PCHR acceptable and easy to use, suggesting that it should be explored as a common medium for health promotion in the workplace.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00142077","term_id":"NCT00142077"}}NCT00142077     

The anti-inflammatory effects of statins on patients with rheumatoid arthritis: A systemic review and meta-analysis of 15 randomized controlled trials

Background

Over the past several years, numerous studies investigated the anti-inflammatory effects of statin on patients with RA. However, the findings of the individual studies were often inconsistent or conflicting.