Development and evaluation of a home-based exercise intervention for frail older people

Background: Frailty is common and is associated with important adverse health outcomes. There is evidence that exercise may influence the biological mechanisms of frailty and improve adverse outcomes. This thesis describes the development and evaluation of the Home-Based Older People's Exercise (HOPE) programme - a home-based exercise intervention for frail older people. Methods: The MRC framework for the development and evaluation of complex interventions was used to develop and evaluate the HOPE programme. The development process synthesised information from four key domains: a systematic literature review; a process of intervention modelling work incorporating multiperspective focus group meetings; a review of behaviour change techniques and a review of international exercise guidelines. Following development, the HOPE programme was evaluated in a pilot randomised controlled trial. The primary outcome was mobility, measured using the Timed-Up-and-Go test (TUGT). Secondary outcomes included activities of daily living (ADL), quality of life and depression. Results: The systematic review identified preliminary evidence that exercise may improve outcomes for frail older people. A grounded theory analysis of the multiperspective focus group meetings identified the important challenges faced by frail older people, along with motivators and barriers to exercise. The results were synthesised into the HOPE programme, which is a 12 week home-based exercise intervention. 60 participants were recruited to the HOPE trial. Mean age was 78 years. Baseline characteristics were similar in the two groups. There was a nonsignificant trend towards an improved outcome in the intervention group (mean adjusted between group difference in TUGT 16.7s, 95% CI -33.3, 66.6s). There were no differences in any of the secondary outcomes. Discussion: The HOPE trial has provided valuable process, resource, management and scientific data to guide the development of a future definitive RCT and has provided important information to help inform future research involving frail older people

Innovative, Scalable and Affordable Interventions for the Treatment of Low Back Pain

The overall aim of the thesis was to investigate innovative, scalable and affordable interventions for the management of low back pain. Chapter Two shows an increasing online public interest in musculoskeletal conditions from 2008, with low back and neck pain being the ones with the highest annual increase (nearly 7%). Chapter Three reviews the use of text messages in the management of musculoskeletal pain. Text messages improved medication adherence compared to usual care and pain, function, quality of life and treatment adherence when added to comprehensive interventions and compared to control. Chapter Four describes the development process of the TEXT4myBACK intervention, which is a self-management text message intervention for people with low back pain. Chapter Five presents the protocol of the randomised controlled trial assessing the effect of the TEXT4myBACK intervention on function of people with low back pain compared to control. Chapter Six explores participants’ experience with the TEXT4myBACK intervention, including its acceptance, usefulness and behaviour-change ability. Chapter Seven proposes a methodology to aid the interpretation of the clinical significance of the TEXT4myBACK trial’s findings. It shows that people need to improve at least 9.4 points on a 0-30 function scale to consider self-management worthwhile. As pain management is complex and influenced by several factors including families, Chapter Eight reviews the effects of family-based interventions on health outcomes of people with musculoskeletal pain. It found that family-based interventions improve pain and disability compared to individual-focused interventions and pain compared to usual care. Chapter Nine explores the feasibility of a telephone health coaching intervention with or without an exercise buddy for people with low back pain compared to usual care and data collection approaches through a pilot and feasibility study. The thesis findings may be used to 1) guide the development of educational and text message interventions for musculoskeletal pain; 2) aid the interpretation of the clinical relevance of the TEXT4myBACK intervention’s effects through a responder analysis; 3) optimise the approaches of future randomised controlled trials including family members or exercise buddies for low back pain

Changing behaviour, ‘more or less’: Investigating whether there is a basis for designing different interventions for implementation and deimplementation.

Background: The process of decreasing ineffective or harmful healthcare (deimplementation) may require different approaches than those used to promote uptake of new procedures (implementation) but research into different approaches is currently lacking. It has not been determined if there is a theoretical and evidence-based rationale for designing different interventions for implementation and de-implementation. Objectives: The objectives of this thesis were to: 1) Investigate whether there is a theoretical basis for identifying different mechanisms of change by which behaviour might increase versus decrease; 2) Assess whether predictors of health professional behaviour differ depending on whether behaviour was one clinicians should implement or behaviours clinicians should de-implement; and 3) Identify the Behaviour Change Techniques of published implementation and de-implementation interventions to determine if there is a difference between the techniques reported in these interventions. Methods: Study 1 used Critical Interpretive Synthesis to investigate whether a theoretical rationale exists for identifying different mechanisms of change by which interventions may work for implementation and de-implementation. Study 2 investigated whether the theoretical constructs commonly used to predict health professional behaviour differ based on whether the behaviours should be implemented or de-implemented. It was an exploratory study involving secondary analysis on 13 existing questionnaire datasets from a variety of healthcare professional groups in primary care settings in the United Kingdom and Canada. Study 3 involved the classification and frequency of Behaviour Change Techniques in implementation and de-implementation interventions from selected Cochrane Effective Practice and Organisation of Care systematic reviews. Findings from these three studies were interpreted using the concurrent triangulation approach to report on the key findings. Results: Operant Learning Theory (OLT) proposes different approaches to increasing and decreasing behaviour changes and therefore implementation and de-implementation interventions (Studies 1 & 3), despite a number of commonly used theories being poor predictors of behaviours for implementation and de-implementation (Study 2). Additionally, whilst the range of techniques was limited, the technique Behaviour substitution was frequently used to decrease health professionals’ behaviours (Study 3) and also identified as a strategy commonly used to decrease behaviour in general (Study 1). Conclusion: Whilst the findings suggest that OLT may be promising in developing different interventions for implementation and de-implementation, how best to use these OLT principles is unclear. In instances whereby Behaviour substitution is part of a de-implementation intervention, it is not clear how best to identify the substitute behaviour. Additional investigation is required to better inform the design of implementation and de-implementation interventions

Combined Nutrition and Exercise Interventions in Community Groups

Diet and physical activity are two key modifiable lifestyle factors that influence health across the lifespan (prevention and management of chronic diseases and reduction of the risk of premature death through several biological mechanisms). Community-based interventions contribute to public health, as they have the potential to reach high population-level impact, through the focus on groups that share a common culture or identity in their natural living environment. While the health benefits of a balanced diet and regular physical activity are commonly studied separately, interventions that combine these two lifestyle factors have the potential to induce greater benefits in community groups rather than strategies focusing only on one or the other. Thus, this Special Issue entitled “Combined Nutrition and Exercise Interventions in Community Groups” is comprised of manuscripts that highlight this combined approach (balanced diet and regular physical activity) in community settings. The contributors to this Special Issue are well-recognized professionals in complementary fields such as education, public health, nutrition, and exercise. This Special Issue highlights the latest research regarding combined nutrition and exercise interventions among different community groups and includes research articles developed through five continents (Africa, Asia, America, Europe and Oceania), as well as reviews and systematic reviews

A phenomenological investigation of patients' lived experiences of medicines adherence: a novel perspective for future intervention development

Approximately 50% of medications are not used as prescribed, this phenomenon is known as non-adherence. The literature concerning this phenomenon focuses on reasons medicines are not taken, dissecting experiences to identify mechanisms that act as barriers and facilitators to using medicines as prescribed. Theoretical frameworks and models have been developed that conceptualise the phenomenon, enabling interventions to be established to improve medicines use. However these interventions have yet to demonstrate sustainable improvements in adherence. A novel perspective of the adherence phenomenon may direct future intervention development that will lead to improved adherence. This project evaluated current literature concerning the adherence phenomenon; concluding that a largely ‘biomedical perspective’ had been taken to understanding patients’ medicines use and that further work was needed that approached the phenomenon from with a novel outlook. A systematic review and thematic synthesis was conducted of evidence that, through phenomenological methods, rejected previously held beliefs and concluded that adherence was experienced by patients as an interaction between the patient’s and the medicine’s identity. The systematic review identified a gap in the literature that described adherence from patients’ lived experiences across different disease states. Using phenomenology, empirical research included forty-one interviews that explored patients’ experiences of medicines use across five disease areas, namely cardiovascular disease, gout, chronic obstructive pulmonary disease, cancer and diabetes. This uncovered a novel description of the phenomenon as a construct of social interaction between the patient, their product and wider society (embodied as family and friends, healthcare professionals, the media and policy). Three focus groups were conducted to validate these findings and locate patients’ perspectives of interventions within this novel description. Analyses from these focus groups identified that current adherence interventions represented micro-social interactions between the patient and the product, with few interventions developed that utilise patients’ interactions with wider society. These works are synthesised to present new directions for future intervention development that might seek to utilise patients’ interactions with friends, family, healthcare professionals and policy to improve adherence

Beliefs and behaviours for preventing occupational health problems among the second-hand clothing sellers in southern Thailand

AimThe overarching aims of this study were to explore what second hand clothing sellers understand about their occupational health risks and how they might minimise and prevent these risks and secondly to explore if this understanding influences to their preventive health behaviours.BackgroundPrevious work I noticed that the sellers were exposed to health risks from working processes such as dust from clothes, UV exposure and heavy lifting without using personal protective equipment such as mask, hat and sunglasses, although these health risks can be protected against by cheap materials and preventive health behaviours to deal with the health risks are not complicated. In the light of the problems as outlined earlier, it is necessary to investigate why these workers are exposed to health threats from a working environment without sufficient protection. It is vital to understand the threats by exploring the understandings of the workers of work exposures, their beliefs, and examine how such understandings may have a role in directions for any preventive health behaviours.Theoretical frameworkHealth Belief Model (HBM) focusing on health beliefs including preventive health behaviour was adopted as a theoretical framework to guide the assimilation of existing evidence and to frame the qualitative ethnographic study.Methodology and methodsEthnographic research methods, underpinned by an interpretative paradigm, were applied to obtain rich, culturally embedded information. Participant observation along with note-taking and photographs as well as ethnographic interviews were contemporaneously conducted over a six months period in Yala province, a district located in the southern border province of Thailand. Ethnographic data analysis based on the principle of HBM theory was utilised to analyse in-depth data from interview transcripts and sets this against a backdrop of detailed observation.ResultThe most significant findings of the present study are as follows: Cues to action which produce information and knowledge are the most important component influencing the other components of HBM according to findings from this market context. It seems that personal indirect experience is highly impactful for behaviour change and is most important for health promotion strategy for second-hand clothing sellers. Perceived barriers (especially discomfort for using personal protective equipment) was the most important component affecting negative working behaviours of second-hand clothing sellers. Limitations to access to information and context specific knowledge of second-hand clothing sellers is considered the most influential cause underpinning the occurrence of inadequate health beliefs and observations of negative work behaviour of second-hand clothing sellers. While the findings may not be surprising, they do add to further insight about the application of the HBM to this unregulated work context, and furthermore provide indicative directions for informing health promotion strategy that is tailored to the context of the market.ConclusionPromotion of knowledge and theoretically informed discussion of beliefs including self-efficacy are considered as indications for health promotion strategy for the sellers

Akzeptanz und Wirksamkeit von Telemedizin- Anwendungen in der medizinischen Regelversorgung am Beispiel des Diabetes mellitus, der Hypertonie und Dyslipidämien

Das Potential von Telemedizin-Anwendungen, die eine medizinische Konsultation von Patient:innen über eine geographische Distanz hinweg ermöglichen, reicht von der Schaffung eines gerechten Zugangs zu Versorgungsangeboten für alle Patient:innen über eine Optimierung medizinischer Versorgungsprozesse bis hin zu einer Verbesserung krankheitsbezogener Outcomes. Um dieses Potential erfüllen zu können, ist es zwingend notwendig, dass für diese Anwendungen der Nachweis sowohl der klinischen Wirksamkeit als auch der Passfähigkeit in das jeweilige Versorgungssetting, in dem sie genutzt werden sollen, erbracht wird. Eine Dimension der Passfähigkeit ist die Akzeptanz der Leistungserbringenden und Patient:innen, die beide per defintionem Endnutzer:innen einer Telemedizinanwendung sind. Die Zielstellung der vorliegenden Arbeit war es daher, Akzeptanz und Wirksamkeit von Telemedizin-Anwendungen wissenschaftlich zu untersuchen. Um die Erkenntnisse der Promotionsschrift in den wissenschaftlichen Kontext der Beforschung von Telemedizin-Anwendungen einzuordnen, wurden zudem zukünftige Forschungsbedarfe auf dem Gebiet der Telemedizin systematisch erhoben und priorisiert. Um diese Ziele zu erreichen, kam ein breites Methodenspektrum zum Einsatz. Zur Erhebung von theoriebasierten Prädiktoren für die Akzeptanz von Telemedizin-Anwendungen durch Patient:innen und Leistungserbringende wurde ein Systematic Review durchgeführt. Zudem wurden die Erwartungen und Wünsche ruandischer Patient:innen mit Diabetes an eine Selbstmanagement-App in qualitativen Interviews erhoben, um den ersten Prototypen einer entsprechenden App auf diese Zielgruppe zuschneiden zu können. Ebenfalls in qualitativen Interviews wurde anschließend untersucht, inwieweit dieser Prototyp den Nutzer:innenerwartungen entsprach. Die Wirksamkeit von Telemedizin-Anwendungen wurde in einem Umbrella Review bestehender Systematic Reviews und Metaanalysen anhand der drei chronischen Krankheitsbilder Diabetes mellitus, Hypertonie und Dyslipidämie exemplarisch untersucht, wobei die verfügbare Evidenz außerdem einer ausführlichen Qualitätsprüfung (GRADE Assessment) unterzogen wurde. Zu guter Letzt wurden von Autor:innen publizierter Systematic Reviews und Metaanalysen genannte zukünftige Forschungsbedarfe auf dem Gebiet der Telemedizin im Rahmen einer qualitativen Inhaltsanalyse kategorisiert und in einen quantitativen Online-Fragebogen überführt. Dieser wurde in den Social Media-Kanälen, auf Webseiten und in Rundschreiben verschiedener Fachgesellschaften auf dem Gebiet der Diabetes-Versorgung, Evidenzbasierten Medizin und Ergotherapie sowie unter Akteuer:innen der Gesundheitsversorgungsplanung verteilt, um zukünftige Forschungsbedarfe auf Sicht von Wissenschaftler:innen, Leistungserbringenden und Entscheidungsträger:innen des Gesundheitssystems zu priorisieren. Diese Kombination qualitativer und quantitativer Forschungsmethoden entspricht einem Mixed Methods-Design. Die Ergebnisse zeigten, dass Telemedizin-Anwendungen von Patient:innen und Leistungserbringenden dann akzeptiert wurden, wenn sie diese für nützlich für das Krankheitsmanagement bzw. die Patient:innenversorgung hielten und sie leicht zu bedienen sind. Für Patient:innen spielte zudem die Akzeptanz durch das soziale Umfeld eine wichtige Rolle. Die entsprechenden theoriebasierten Prädiktoren waren in den betrachteten Studien am häufigsten signifikant und erzielten hohe Effektstärken. Modelle der Technikakzeptanz, insbesondere das Technology Assessment Model und seine Erweiterung, die Unified Theory of Acceptance and Use of Technology, sind klassischen Verhaltenstheorien, aus denen heraus sie entwickelt wurden, in ihrer Erklärungskraft hinsichtlich der Akzeptanz von Telemedizin-Anwendungen, gemessen anhand der Varianzaufklärung, überlegen. Die an den Interviews teilnehmenden ruandischen Patient:innen mit Diabetes wünschten sich von einer App für das Diabetes-Selbstmanagement vor allem, dass diese ihnen Informationen zu Krankheitsverlauf, Symptomen, Warnsignalen für Komplikationen sowie gesundheitsförderlichen Verhaltensweisen (Ernährung und Bewegung) in übersichtlicher, leicht verständlicher Form darböte. Zudem sollte die App eine Reminder-Funktion mit Bezug auf Selbsttestung des Blutzuckerwerts, Medikamenteneinnahme und sportlicher Aktivität beinhalten. Der erste Prototyp der App wurde insbesondere aufgrund des Erkenntnisgewinns zu den oben genannten Themen und der umgesetzten niedrigschwelligen Erinnerungen für das Diabetes-Selbstmanagement im Alltag durch die Nutzer:innen positiv bewertet. Allerdings bemängelten sie die fehlende Option zum sozialen Austausch mit anderen Patient:innen und die rein text- und bildbasierte anstelle einer interaktiven Informationsvermittlung. Für Patienten mit Diabetes konnten signifikante, klinisch relevante Reduktionen des HbA1c durch Telemedizinanwendungen festgestellt werden, wobei Patient:innen mit einer kürzlich erfolgten Diagnose und jene mit einem erhöhten Baseline-HbA1c (> 8 % mmol/l) mehr von der Nutzung profitierten. Interventionen, die Feedback zu den von Patient:innen selbst gemessenen Werten durch Leistungserbringende ermöglichtem, führten zu größeren klinischen Effekten, wobei für die Art des Feedbacks (Telefon, SMS, automatisiert oder manuell) kein Unterschied zu beobachten war. Signifikante – jedoch klinisch nicht relevante – Reduktionen des Blutdrucks bei Patient:innen mit Hypertonie konnten festgestellt werden. Der Einsatz von Telemedizin-Anwendungen hatte keinen signifikanten klinischen Effekt auf die LDL- , HDL-c-, Triglycerid- und Total Cholesterol-Werte bei Patient:innen mit Diabetes. Anwendungen, die ausschließlich auf Dyslipidämien ohne Komorbiditäten abstellten, wurden in den eingeschlossenen Reviews und Meta-Analysen nicht untersucht. Die Qualitätsprüfung der eingeschlossenen Übersichtsarbeiten zeigte teils gravierende Mängel insbesondere der Metaanalysen auf. So waren vor allem das Risiko für Verzerrungspotential in den jeweils gepoolten Effektschätzern, vor allem aufgrund fehlender Verblindung sowohl der Studienteilnehmenden als auch der –assessor:innen, und die Heterogenität der verglichenen Interventionen, Studienpopulationen und Interventionsdauern hoch. Forschende auf dem Gebiet der Telemedizin sowie Leistungserbringende und Entscheidungsträger:innen des Gesundheitswesens priorisierten insbesondere die systematische Entwicklung und Evaluation von Implementierungsstrategien, den Zuschnitt von Telemedizin-Anwendungen auf klar definierte Zielgruppen und den Datenschutz als zukünftige Forschungsbedarfe auf dem Gebiet der Telemedizin. Gemeinsam belegen die Ergebnisse die Relevanz theoriegeleitet entwickelter Implementierungsstrategien, die die Nutzer:innenakzeptanz berücksichtigen und die potentiellen Nutzer:innengruppen in den Entwicklungsprozess von Telemedizin-Anwendungen mit einbeziehen. Die klinische Wirksamkeit von Telemedizin-Anwendungen ist zwar für einzelne Krankheitsbilder, insbesondere den Diabetes, nachweisbar, sollte aber anhand methodisch robuster Studiendesigns bestätigt werden, die dem multimodalen Charakter digitaler Interventionen Rechnung tragen. Subgruppenanalysen zur Identifikation von Patient:innengruppen, die besonders vom Einsatz von Telemedizin profitieren sowie die Identifikation von wirksamen Anwendungskomponenten sollten in Evaluationsstudien umgesetzt werden. Das erwartete Potential von Telemedizin-Anwendungen war ursächlich für die Beschleunigung der Zulassung Digitaler Gesundheitsanwendungen (DiGA) im deutschen Gesundheitssystem, die im Jahr 2020 gesetzlich beschlossen wurde und seitdem durch das BfArM in einem Fast Track-Verfahren umgesetzt wird. DiGA entsprechen aufgrund ihrer Zweckbestimmung, einen patient:innenrelevanten Nutzen durch den Einsatz digitaler Anwendungen zu generieren, in weiten Teilen der Telemedizin-Definition und sollen nach einer Testphase von nur einem Jahr in die Regelversorgung übernommen werden. Die Ergebnisse der Promotionsschrift sind somit von Relevanz für die zukünftige Ausgestaltung des BfArM-Fast Tracks zur Zulassung von DiGA

A theory-based investigation of patient and healthcare professional behaviours linked to optimal removal of short-term urinary catheters

Ph. D. ThesisCatheter-associated urinary tract infections (CAUTIs) are among the most prevalent healthcare-acquired infections. Prolonged catheter duration increases CAUTI risk by 5% per day. The average duration of postoperative short-term urinary catheterisation in the UK remains higher than recommended standards. Implementation of early catheter removal guidance is likely influenced by patient and healthcare professional (HCP) factors. This research investigates behavioural determinants (barriers and enablers) of prolonged catheter duration using the theoretical domains framework (TDF). Study 1 (literature review) highlighted that existing interventions and current guidance on catheter removal focus on either limiting the use of urinary catheters or on early catheter removal. A combination of strategies appears more effective than a singular strategy, but sustained improvement over time remains unclear. Current UK guidelines on the timing of catheter removal were non-specific. Two TDF-based interview studies explored barriers and enablers to prolonged catheter duration with hospital-based HCPs (doctors, nurses and ancillary staff) (Study 2) and with hospitalised/catheterised patients (Study 3). For HCPs, several key barriers to catheter removal practice were identified, for example, low motivation to remove catheters promptly due to competing demands; poor knowledge of removal guidance and evidence-based practice. Key enablers for HCPs included being highly skilled at removing catheters; the use of handover notes, reminders and daily task lists; and having senior and specialised colleagues as role models. Patient barriers to engaging with HCPs were, for example, perceived inability to manage without a catheter/dependence on the catheter, environmental and resource factors such as the lack of accessible toilets and staff assistance with toileting, staff attitudes, and ward culture. Patient enablers were: motivation to engage to speed-up hospital discharge and social support from the family. A range of modifiable barriers linked to HCP and patient-related behaviours were identified which may help explain the prolonged duration of short-term urinary catheters. A behaviour change intervention targeting these barriers whilst strengthening the enablers may reduce catheter duration and subsequently CAUTIs.National Institute for Health Research (NIHR