scholarly journals A theory-based multicomponent intervention to reduce occupational sedentary behaviour in professional male workers: protocol for a cluster randomised crossover pilot feasibility study

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Gail Helena Nicolson ◽  
Catherine Hayes ◽  
Catherine Darker
Keyword(s):  
Pilot Study ◽  
Sedentary Behaviour ◽  
Controlled Trial ◽  
Significant Risk ◽  
Current Evidence ◽  
Physical Work ◽  
Workplace Intervention ◽  
Behaviour Change Techniques ◽  
Multicomponent Intervention ◽  
Cluster Randomised

Abstract Background Prolonged sitting, a significant risk factor for increased morbidity and mortality, is accumulated mostly in the workplace. There is limited research targeting specific at-risk populations to reduce occupational sedentary behaviour. A recent study found that professional males have the longest workplace sitting times. Current evidence supports the use of multi-level interventions developed using participative approaches. This study’s primary aims are to test the viability of a future definitive intervention trial using a randomised pilot study, with secondary aims to explore the acceptability and feasibility of a multicomponent intervention to reduce workplace sitting. Methods Two professional companies in Dublin, Ireland, will take part in a cluster randomised crossover pilot study. Office-based males will be recruited and randomised to the control or the intervention arms. The components of the intervention target multiple levels of influence including individual determinants (via mHealth technology to support behaviour change techniques), the physical work environment (via provision of an under-desk pedal machine), and the organisational structures and culture (via management consultation and recruitment to the study). The outcomes measured are recruitment and retention, minutes spent sedentary, and physical activity behaviours, work engagement, and acceptability and feasibility of the workplace intervention. Discussion This study will establish the acceptability and feasibility of a workplace intervention which aims to reduce workplace SB and increase PA. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of this intervention in a definitive cluster randomised controlled trial.

scholarly journals The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

2021 ◽  
Author(s):  
Lisa Hynes ◽  
Andrew W Murphy ◽  
Nigel Hart ◽  
Collette Kirwan ◽  
Sarah Mulligan ◽  
...  
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Medication Reviews ◽  
Randomised Controlled

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

scholarly journals A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
D. E. Patton ◽  
J. J. Francis ◽  
E. Clark ◽  
F. Smith ◽  
C. A. Cadogan ◽  
...  
Keyword(s):  
Pilot Study ◽  
Process Evaluation ◽  
Behaviour Change ◽  
Older Patients ◽  
Controlled Trial ◽  
Theoretical Domains Framework ◽  
Self Report ◽  
Community Pharmacies ◽  
Behaviour Change Techniques ◽  
Limited Effectiveness

Abstract Background Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. Methods As part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3–4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient’s underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention’s mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive. Discussion Using pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients’ adherence behaviour and guide further refinement of the intervention and study procedures. Trial registration This study is registered at ISRCTN: 10.1186/ISRCTN73831533

scholarly journals Increasing physical activity in older adults using STARFISH, an interactive smartphone application (app); a pilot study

2017 ◽  
Vol 4 ◽  
pp. 205566831769623 ◽  
Author(s):  
Lorna Paul ◽  
Stephen Brewster ◽  
Sally Wyke ◽  
Angus K McFadyen ◽  
Naveed Sattar ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Pilot Study ◽  
Controlled Trial ◽  
Objective Measure ◽  
Smartphone Application ◽  
Behaviour Change Techniques ◽  
Self Monitoring ◽  
Steps Per Day ◽  
Randomised Controlled

Background Increasing physical activity in older adults has preventative and therapeutic health benefits. We have developed STARFISH, a smartphone application, to increase physical activity. This paper describes the features of STARFISH, presents the views of older users on the acceptability and usability of the app and reports the results of a six week pilot study of the STARFISH app in older adults. Methods The operationalisation of the behaviour change techniques (BCTs) within the STARFISH app was mapped against the BCT Taxonomy of Michie et al. Sixteen healthy older adults (eight women and eight men; age 71.1 ± 5.2 years) used the app, in groups of four, for six weeks. Focus groups explored the user experience and objective measure of steps per day recorded. Results Participants were very positive about using the STARFISH app, in particular the embedded BCTs of self-monitoring, feedback and social support (in the form of group rewards). Objective step data, available for eight participants, showed that step counts increased by an average of 14% ( p = 0.077, d = 0.56). Conclusion The STARFISH app was acceptable and straightforward to use for older adults. STARFISH has potential to increase physical activity in older adults; however, a fully powered randomised controlled trial is required.

scholarly journals SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial

2021 ◽  
Vol 2 ◽  
Author(s):  
Shobhana Nagraj ◽  
Stephen H. Kennedy ◽  
Vivekananda Jha ◽  
Robyn Norton ◽  
Lisa Hinton ◽  
...  
Keyword(s):  
Decision Support ◽  
Pilot Study ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Rural India ◽  
Cluster Randomised ◽  
Randomised Controlled

Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy.Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods.Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03968952.

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