Mobile health technologies to improve walking distance in people with intermittent claudication.

BACKGROUND: Peripheral arterial disease (PAD) is the obstruction or narrowing of the large arteries of the lower limbs, which can result in impaired oxygen supply to the muscle and other tissues during exercise, or even at rest in more severe cases. PAD is classified into five categories (Fontaine classification). It may be asymptomatic or various levels of claudication pain may be present; at a later stage, there may be ulceration or gangrene of the limb, with amputation occasionally being required. About 20% of people with PAD suffer from intermittent claudication (IC), which is muscular discomfort in the lower extremities induced by exertion and relieved by rest within 10 minutes; IC causes restriction of movement in daily life. Treatment for people with IC involves addressing lifestyle risk factors. Exercise is an important part of treatment, but supervised exercise programmes for individuals with IC have low engagement levels and high attrition rates. The use of mobile technologies has been suggested as a new way to engage people with IC in walking exercise interventions. The novelty of the intervention, low cost for the user, automation, and ease of access are some of the advantages mobile health (mhealth) technologies provide that give them the potential to be effective in boosting physical activity in adults. OBJECTIVES: To assess the benefits and harms of mobile health (mhealth) technologies to improve walking distance in people with intermittent claudication. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL, and also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The most recent searches were carried out on 19 December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in people aged 18 years or over with symptomatic PAD and a clinical diagnosis of IC. We included RCTs comparing mhealth interventions to improve walking distance versus usual care (no intervention or non-exercise advice), exercise advice, or supervised exercise programmes. We excluded people with chronic limb-threatening ischaemia (Fontaine III and IV). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were change in absolute walking distance from baseline, change in claudication distance from baseline, amputation-free survival, revascularisation-free survival. Our secondary outcomes were major adverse cardiovascular events, major adverse limb events, above-ankle amputation, quality of life, and adverse events. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 614 participants with a clinical diagnosis of IC. The duration of intervention of the four included RCTs ranged from 3 to 12 months. Participants were randomised to either mhealth or control (usual care or supervised exercise programme). All four studies had an unclear or high risk of bias in one or several domains. The most prevalent risk of bias was in the area of performance bias, which was rated high risk as it is not possible to blind participants and personnel in this type of trial. Based on GRADE criteria, we downgraded the certainty of the evidence to low, due to concerns about risk of bias, imprecision, and clinical inconsistency. Comparing mhealth with usual care, there was no clear evidence of an effect on absolute walking distance (mean difference 9.99 metres, 95% confidence interval (CI) -27.96 to 47.93; 2 studies, 503 participants; low-certainty evidence). None of the included studies reported on change in claudication walking distance, amputation-free survival, or revascularisation-free survival. Only one study reported on major adverse cardiovascular events (MACE) and found no clear difference between groups (risk ratio 1.37, 95% CI 0.07 to 28.17; 1 study, 305 participants; low-certainty evidence). None of the included studies reported on major adverse limb events (MALE) or above-ankle amputations. AUTHORS' CONCLUSIONS: Mobile health technologies can be used to provide lifestyle interventions for people with chronic conditions, such as IC. We identified a limited number of studies that met our inclusion criteria. We found no clear difference between mhealth and usual care in improving absolute walking distance in people with IC; however, we judged the evidence to be low certainty. Larger, well-designed RCTs are needed to provide adequate statistical power to reliably evaluate the effects of mhealth technologies on walking distance in people with IC.

Harnessing digital health to optimise the delivery of guideline-based cardiac rehabilitation during COVID-19: an observational study.

BACKGROUND: The COVID-19 pandemic accelerated the uptake of digital health interventions for the delivery of cardiac rehabilitation (CR). However, there is a need to evaluate these interventions. METHODS: We examined the impact of an evidence-based, digital CR programme on medical, lifestyle and psychosocial outcomes. Delivered by an interdisciplinary team of healthcare professionals, the core components of this 12-week programme included lifestyle modification, medical risk factor management, psychosocial and behavioural change support. To support self-management, patients were provided with a Fitbit, a home blood pressure (BP) monitor and an interactive workbook. Patients received access to a bespoke web-based platform and were invited to attend weekly, online group-based supervised exercise sessions and educational workshops. Outcomes were assessed at baseline, end of programme and at 6-month follow-up. RESULTS: Over a 3-month period, 105 patients (88% with coronary heart disease) were referred with 74% (n=77) attending initial assessment. Of these, 97% (n=75) enrolled in the programme, with 85% (n=64) completing the programme, 86% (n=55) of completers attended 6-month follow-up. Comparing baseline to end of programme, we observed significant improvements in the proportion of patients meeting guideline-recommended targets for physical activity (+68%, p<0.001), BP (+44%, p<0.001) and low-density lipoprotein cholesterol (+27%, p<0.001). There were significant reductions in mean weight (-2.6 kg, p<0.001). Adherence to the Mediterranean diet score improved from 5.2 to 7.3 (p<0.001). Anxiety and depression levels (Hospital Anxiety and Depression score) both reduced by more than 50% (p<0.001). The majority of these improvements were sustained at 6-month follow-up. CONCLUSION: Outcomes from this study suggest that interdisciplinary digital CR programmes can be successfully implemented and help patients achieve guideline recommended lifestyle, medical and therapeutic targets.

Monitoring and Evaluation of Patient Engagement in Health Product Research and Development: Co-Creating a Framework for Community Advisory Boards.

PURPOSE: While patient engagement is becoming more customary in developing health products, its monitoring and evaluation to understand processes and enhance impact are challenging. This article describes a patient engagement monitoring and evaluation (PEME) framework, co-created and tailored to the context of community advisory boards (CABs) for rare diseases in Europe. It can be used to stimulate learning and evaluate impacts of engagement activities. METHODS: A participatory approach was used in which data collection and analysis were iterative. The process was based on the principles of interactive learning and action and guided by the PEME framework. Data were collected via document analysis, reflection sessions, a questionnaire, and a workshop. RESULTS: The tailored framework consists of a theory of change model with metrics explaining how CABs can reach their objectives. Of 61 identified metrics, 17 metrics for monitoring the patient engagement process and short-term outcomes were selected, and a "menu" for evaluating long-term impacts was created. Example metrics include "Industry representatives' understanding of patients' unmet needs;" "Feeling of trust between stakeholders;" and "Feeling of preparedness." "Alignment of research programs with patients' needs" was the highest-ranked metric for long-term impact. CONCLUSIONS: Findings suggest that process and short-term outcome metrics could be standardized across CABs, whereas long-term impact metrics may need to be tailored to the collaboration from a proposed menu. Accordingly, we recommend that others adapt and refine the PEME framework as appropriate. The next steps include implementing and testing the evaluation framework to stimulate learning and share impacts.

A Cross-Sectional Analysis of Physical Activity Patterns, Aerobic Capacity and Perceptions about Exercise among Male Farmers in the Mid-West Region of Ireland.

In Ireland, farmers have been identified as a high-risk population, with higher rates of cardiovascular disease (CVD) and overall mortality, compared with the general population. Farming has always been considered a physically active lifestyle. However, in recent times, with the increased use of technology and machinery, farmers may not be completing as much physical activity as before. There is a lack of research on physical activity patterns, fitness, and perception about exercise among farmers. Physical activity patterns were assessed using ActivPAL3 micro monitors for a duration of 7 consecutive days. Aerobic capacity was measured using a validated sub-maximal exercise test to calculate Metabolic Equivalent Task (MET) levels. The Exercise Benefits and Barriers Scale (EBBS) questionnaire was used to explore perceived benefits and barriers towards exercise. Farmers completed a mean (standard deviation) of 16,452 (5,170) steps and 124 (43) minutes of moderate-vigorous intensity physical activity (MVPA) daily. The volume of weekly MVPA was largely accumulated in bouts lasting <10 minutes, with only 17.89% completing bouts of ≥10 minutes. Daily sitting time was 8.26 hours. Farmers are fit, have positive perceptions about exercise, and complete large quantities of physical activity, but not in a CVD protective pattern. CVD risk can be reduced in this population by encouraging them to sit less and engage in MVPA in bouts of ≥10 minutes, in line with current guidelines.

Improved Quality of Life, Fitness, Mental Health and Cardiovascular Risk Factors with a Publicly Funded Bariatric Lifestyle Intervention for Adults with Severe Obesity: A Prospective Cohort Study.

BACKGROUND: Lifestyle modification is the cornerstone of management for patients with severe and complicated obesity, but the effects of structured lifestyle programmes on quality of life, anxiety and depression scores and cardiovascular risk factors are not well-described. We sought to describe changes in self-reported quality of life and mental health-related outcomes as well as cardiovascular risk factors in patients completing a 10-week multidisciplinary lifestyle-modification programme. METHODS: We conducted a prospective cohort study of all patients referred from our bariatric service who completed the programme between 2013 and 2019. In addition to weight, body mass index (BMI), blood pressure, HbA1c, lipid profile and functional capacity, we quantified health-related quality of life using the Dartmouth COOP Questionnaire and the European Quality of Life Questionnaire Visual Analogue Scale (EQVAS) and mental health using the Hospital Anxiety and Depression Scale (HADS). RESULTS: Of 1122 patients who started the programme, 877 (78.2%) completed it and were included in per protocol analyses. Mean age was 47.3 ± 11.9 years, 66.9% were female, 34.8% were in full- or part-time employment and 69.4% were entitled to state-provided medical care. BMI decreased from 47.0 ± 7.8 to 46.2 ± 7.8 kg m-2 and weight decreased from 131.6 ± 25.5 to 129.5 ± 25.4 kg (both p < 0.001). There were significant reductions in anxiety and depression scores and improvements in all Dartmouth COOP domains. The EQVAS score increased from 52 ± 22 to 63 ± 19 (p < 0.001). Small but statistically significant reductions in LDL cholesterol, systolic blood pressure and HBA1c were also observed. CONCLUSIONS: Adults with severe and complicated obesity completing a specialised bariatric lifestyle-modification programme showed significant improvements in self-reported mental health and quality of life, in addition to reductions in cardiovascular risk factors.

Identifying the active ingredients of cardiac rehabilitation: A behaviour change technique and qualitative analysis.

OBJECTIVES: Despite evidence that cardiac rehabilitation (CR) can be effective, the active ingredients or behaviour change techniques (BCTs) constituting effective CR remain unclear. There is also a lack of research surrounding patient and facilitator perceptions of active ingredients. This study sought to identify the active ingredients of a community-based CR programme and explore patient and facilitator perceptions of the active ingredients. DESIGN: A multimethod design conducted in two stages, a BCT coding stage and a qualitative stage. METHODS: The BCT coding stage involved the observation and audio recording of ten sessions from a community-based CR programme and the collection of programme materials. Data were coded using the BCT Taxonomy version 1 (Ann Behav Med, 46, 2013, 81). During the qualitative stage, six focus groups were carried out separately with patients (n = 16) and facilitators (n = 4). Qualitative data were analysed using an inductive thematic analysis. RESULTS: The BCT coding phase identified 34 BCTs, many of which were highlighted by patients and facilitators. Patients and facilitators felt the group effort, motivation provided by facilitators, individualized care, knowledge gained, acceptance, and fear reduction enabled change. The majority of BCTs identified in the qualitative stage were also identified in the BCT coding stage, excluding a component related to self-acceptance. Facilitators felt the programme was limited by duration and inadequate psychological support. CONCLUSIONS: The study provides a comprehensive overview of objectively coded BCTs and perceived active ingredients of CR. The findings can be used to inform future refinement and improvement of CR.

The role of public health nurses in risk factor modification within a high-risk cardiovascular disease population in Ireland - a qualitative analysis.

BACKGROUND/AIMS: Health promotion for cardiovascular disease risk factors management is essential to secondary prevention of cardiovascular disease events. In Ireland, post-cardiac rehabilitation patients are discharged into the care of community public health nurses, who have a health promotion role. Little is known of the public health nurses' perceptions or knowledge surrounding their role in cardiovascular disease risk factor management. Underpinned by a constructivist viewpoint, this study aims to generate empirical evidence on the phenomenon directly from public health nurses' encounters within the context of the current health service. METHODS: This qualitative cross-sectional analysis involved face-to-face, semi-structured interviews with a purposeful sample of 17 public health nurses. Interviews were audio-recorded, transcribed, subjected to thematic content analysis and subsequently reported incorporating verbatim quotes. RESULTS: A significant gap exists between evidence-based guidelines for cardiovascular disease prevention and current practices. Variations in public health nurses' training, experience and knowledge result in inconsistent practices, and public health nurses feel this is specialised area for which they are not equipped. The changing public health nurse role and increasing workloads result in prioritisation of other nursing duties over health promotion. Ineffective systems for care delivery and a lack of community-based rehabilitation programmes also negatively impact on secondary prevention practices. CONCLUSIONS: Findings support the need to develop a community cardiovascular disease specialist role to effectively support ongoing cardiovascular disease risk factor management. Evaluation of the mechanisms of current service delivery is required to ensure a quality-assured equitable service, in line with community needs and current evidence-based guidelines for practice. A quantitative triangulation study is recommended.