Introduction: Hip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care. Methods: This study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation. Discussion: After a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants' behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs.
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Patients with coronary artery disease (CAD) are more sedentary compared with the general population, but contemporary cardiac rehabilitation (CR) programmes do not specifically target sedentary behaviour (SB). We developed a 12-week, hybrid (centre-based+home-based) Sedentary behaviour IntervenTion as a personaLisEd Secondary prevention Strategy (SIT LESS). The SIT LESS programme is tailored to the needs of patients with CAD, using evidence-based behavioural change methods and an activity tracker connected to an online dashboard to enable self-monitoring and remote coaching. Following the intervention mapping principles, we first identified determinants of SB from literature to adapt theory-based methods and practical applications to target SB and then evaluated the intervention in advisory board meetings with patients and nurse specialists. This resulted in four core components of SIT LESS: (1) patient education, (2) goal setting, (3) motivational interviewing with coping planning, and (4) (tele)monitoring using a pocket-worn activity tracker connected to a smartphone application and providing vibrotactile feedback after prolonged sedentary bouts. We hypothesise that adding SIT LESS to contemporary CR will reduce SB in patients with CAD to a greater extent compared with usual care. Therefore, 212 patients with CAD will be recruited from two Dutch hospitals and randomised to CR (control) or CR+SIT LESS (intervention). Patients will be assessed prior to, immediately after and 3 months after CR. The primary comparison relates to the pre-CR versus post-CR difference in SB (objectively assessed in min/day) between the control and intervention groups. Secondary outcomes include between-group differences in SB characteristics (eg, number of sedentary bouts); change in SB 3 months after CR; changes in light-intensity and moderate-to-vigorous-intensity physical activity; quality of life; and patients’ competencies for self-management. Outcomes of the SIT LESS randomised clinical trial will provide novel insight into the effectiveness of a structured, hybrid and personalised behaviour change intervention to attenuate SB in patients with CAD participating in CR.
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AimTo evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse‐coordinated transitional care intervention in older cardiac patients to understand and interpret the study results.DesignA mixed‐methods process evaluation based on the Medical Research Council Process Evaluation framework.MethodsQuantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi‐structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data‐analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence.ResultsThe overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in‐hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention.ConclusionAlthough involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non‐significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population.ImpactIn addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients.
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