Objectives In two randomised controlled trials, the Plants for Joints (PFJ) multidisciplinary lifestyle intervention reduced signs and symptoms of rheumatoid arthritis (RA), or metabolic syndrome-associated hip or knee osteoarthritis (MSOA) compared with usual care. The current study investigated long-term outcomes.Methods After completion of two 16-week trials in people with (1) RA or (2) MSOA, control groups switched to the active PFJ intervention. At the end of the intervention, all participants were followed up in a 1-year observational extension study. Primary outcomes were 28-joint Disease Activity Score (DAS28) (RA) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (MSOA). Secondary outcomes included body composition, metabolic outcomes, medication changes and intervention adherence. An intention-to-treat analysis with a linear mixed model was used to analyse within-group changes.Results 65 (84%) of 77 RA participants and 49 (77%) of 64 MSOA participants completed the extension study. The effects of the PFJ intervention were replicated in the original control groups and sustained within the RA group a year after intervention completion (mean DAS28 –0.9 points; p<0.001), while in the MSOA group mean WOMAC increased towards but remained well under the starting value (–7.8 points, p<0.001). Improvements in C-reactive protein, waist circumference (RA and MSOA); low-density lipoprotein cholesterol (RA); and weight, haemoglobin A1c, blood pressure (MSOA) were also sustained. Participants had a net decrease of medication, and intervention adherence was largely sustained.Conclusions A year after the PFJ lifestyle intervention, improvements of disease activity and metabolic outcomes within RA and MSOA groups were largely sustained and related to sustained adherence, with a net decrease of medication.Trial registration numbers NL7800, NL7801.
MULTIFILE
Background: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. Methods/design: A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants’ satisfaction. Discussion: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice.
BACKGROUND: Among patients with coronary artery disease (CAD), improvement of lifestyle-related risk factors (LRFs) reduces cardiovascular morbidity and mortality. However, modification of LRFs is highly challenging.OBJECTIVES: This study sought to evaluate the impact of combining community-based lifestyle programs with regular hospital-based secondary prevention.METHODS: The authors performed a randomized controlled trial of nurse-coordinated referral of patients and their partners to 3 widely available community-based lifestyle programs, in 15 hospitals in the Netherlands. Patients admitted for acute coronary syndrome and/or revascularization, with ≥1 LRF (body mass index >27 kg/m(2), self-reported physical inactivity, and/or smoking) were included. All patients received guideline-based usual care. The intervention was based on 3 lifestyle programs for weight reduction, increasing physical activity, and smoking cessation. The primary outcome was the proportion of success at 12 months, defined as improvement in ≥1 qualifying LRF using weight (≥5% reduction), 6-min-walking distance (≥10% improvement), and urinary cotinine (200 ng/ml detection limit) without deterioration in the other 2.RESULTS: The authors randomized 824 patients. Complete data on the primary outcome were available in 711 patients. The proportion of successful patients in the intervention group was 37% (133 of 360) compared with 26% (91 of 351) in the control group (p = 0.002; risk ratio: 1.43; 95% confidence interval: 1.14 to 1.78). In the intervention group, partner participation was associated with a significantly greater success rate (46% vs. 34%; p = 0.03).CONCLUSIONS: Among patients with coronary artery disease, nurse-coordinated referral to a comprehensive set of community-based, widely available lifestyle interventions, with optional partner participation, leads to significant improvements in LRFs. (RESPONSE-2: Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2; NTR3937).
