scholarly journals Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Marian C Brady ◽  
David J Stott ◽  
John Norrie ◽  
Campbell Chalmers ◽  
Bridget St George ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Healthcare Intervention ◽  
Randomised Controlled

scholarly journals The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041891
Author(s):  
André Kratzer ◽  
Jennifer Scheel ◽  
Karin Wolf-Ostermann ◽  
Annika Schmidt ◽  
Katrin Ratz ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mixed Methods ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Complex Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
People With Dementia ◽  
Randomised Controlled

IntroductionShared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs.Methods and analysisBased on the UK Medical Research Council framework ‘Developing and evaluating complex interventions’, a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ (‘m’=motor training; ‘k’=cognitive training; ‘+’=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020.Ethics and disseminationAll procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations.Trial registration numberISRCTN89825211.

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

scholarly journals Lay Health Trainers Supporting Self-Management amongst Those with Low Heath Literacy and Diabetes: Lessons from a Mixed Methods Pilot, Feasibility Study

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Bernadette Bartlam ◽  
Trishna Rathod ◽  
Gillian Rowlands ◽  
Joanne Protheroe
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Structured Interview ◽  
Health Care Practitioner ◽  
Self Management ◽  
Baseline Survey ◽  
Ageing Population ◽  
Randomised Controlled

This article reports a mixed methods process evaluation of a pilot feasibility randomised controlled trial comparing a Lay Health Trainer (LHT) intervention and usual care for those with poorly controlled Type 2 Diabetes Melitus (T2DM). Set in a deprived area in the UK, this research explores patient and health care practitioner (HCP) views on whether a structured interview between a patient and a Lay Health Trainer (LHT), for the purpose of developing a tailored self-management plan for patients, is acceptable and likely to change health behaviours. In doing so, it considers the implications for a future, randomised controlled trial (RCT). Participants were patients, LHTs delivering the intervention, service managers, and practice nurses recruiting patients to the study. Patients were purposively sampled on their responses to a baseline survey, and semistructured interviews were conducted within an exploratory thematic analysis framework. Findings indicate that the intervention is acceptable to patients and HCPs. However, LHTs found it challenging to work with older patients with long-term and/or complex conditions. In order to address this, given an ageing population and concomitant increases in those with such health needs, LHT training should develop skills working with these populations. The design of any future RCT intervention should take account of this.

scholarly journals Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e031819
Author(s):  
Marijn C Verwijs ◽  
Stephen Agaba ◽  
Marie Michele Umulisa ◽  
Mireille Uwineza ◽  
Adrien Nivoliez ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Sexual Risk ◽  
Controlled Trial ◽  
Vaginal Infections ◽  
Pilot Randomised Controlled Trial ◽  
Steady Partner ◽  
Face To Face ◽  
Male Clients ◽  
Randomised Controlled

ObjectivesTo evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.DesignRepeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.SettingResearch clinic in Kigali, Rwanda.ParticipantsRwandan women with high sexual risk.InterventionsWomen diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.Outcome measuresAdherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).ResultsMost women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.ConclusionsHigh-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.Trial registration numberNCT02459665.

scholarly journals A randomised controlled trial of a complex intervention to reduce children’s exposure to secondhand smoke in the home

2017 ◽  
Vol 27 (2) ◽  
pp. 155-162 ◽  
Author(s):  
Elena Ratschen ◽  
Rebecca Thorley ◽  
Laura Jones ◽  
Magdalena Opazo Breton ◽  
Juliette Cook ◽  
...  
Keyword(s):  
Air Quality ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Nicotine Dependence ◽  
Complex Intervention ◽  
Secondhand Smoke ◽  
Controlled Trial ◽  
Cigarette Consumption ◽  
Salivary Cotinine ◽  
Randomised Controlled

ObjectivesExposing children to secondhand tobacco smoke (SHS) causes significant harm and occurs predominantly through smoking by caregivers in the family home. We report a trial of a complex intervention designed to reduce secondhand smoke exposure of children whose primary caregiver feels unable or unwilling to quit smoking.DesignAn open-label, parallel, randomised controlled trial.SettingDeprived communities in Nottingham City and County, EnglandParticipantsCaregivers resident in Nottingham City and County in England who were at least 18 years old, the main caregiver of a child aged under 5 years living in their household, and reported that they were smoking tobacco inside their home.InterventionsWe compared a complex intervention combining personalised feedback on home air quality, behavioural support and nicotine replacement therapy for temporary abstinence with usual care.Main outcomesThe primary outcome was change in air quality in the home, measured as average 16–24  hours levels of particulate matter of  < 2.5  µm diameter (PM2.5), between baseline and 12 weeks. Secondary outcomes included changes in maximum PM2.5, proportion of time PM2.5 exceeded WHO recommended levels of maximum exposure of 25  µg/mg3, child salivary cotinine, caregivers’ cigarette consumption, nicotine dependence, determination to stop smoking, quit attempts and quitting altogether during the intervention.ResultsArithmetic mean PM2.5 decreased significantly more (by 35.2 %; 95%  CI 12.7% to 51.9 %) in intervention than in usual care households, as did the proportion of time PM2.5 exceeded 25  µg/mg3, child salivary cotinine concentrations, caregivers’ cigarette consumption in the home, nicotine dependence, determination to quit and likelihood of having made a quit attempt.ConclusionsBy reducing exposure to SHS in the homes of children who live with smokers unable or unwilling to quit, this intervention offers huge potential to reduce children’s’ tobacco-related harm.Trial registration numberISRCTN81701383.This trial was funded by the UK National Institute for Health Research (NIHR): RP-PG-0608-10020

scholarly journals Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028427 ◽  
Author(s):  
Charilaos Lygidakis ◽  
Jean Paul Uwizihiwe ◽  
Per Kallestrup ◽  
Michela Bia ◽  
Jeanine Condo ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Integrated Management ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Chronic Patients ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionIn Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction.Methods and analysisThis is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.Ethics and disseminationEthics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT03376607; Pre-results.

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