scholarly journals How feasible are lifestyle modification programs for disease prevention in general practice?

2012 ◽  
Vol 18 (2) ◽  
pp. 129 ◽  
Author(s):  
Heike Schütze ◽  
Elizabeth F. Rix ◽  
Rachel A. Laws ◽  
Megan Passey ◽  
Mahnaz Fanaian ◽  
...  
Keyword(s):  
General Practice ◽  
Vascular Disease ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Lifestyle Changes ◽  
Health Providers ◽  
Structured Interviews ◽  
Lifestyle Modification Program

Vascular disease is a leading cause of death and disability. While it is preventable, little is known about the feasibility or acceptability of implementing interventions to prevent vascular disease in Australian primary health care. We conducted a cluster randomised controlled trial assessing prevention of vascular disease in patients aged 40–65 by providing a lifestyle modification program in general practice. Interviews with 13 general practices in the intervention arm of this trial examined their views on implementing the lifestyle modification program in general practice settings. Qualitative study, involving thematic analysis of semi-structured interviews with 11 general practitioners, four practice nurses and five allied health providers between October 2009 and April 2010. Providing brief lifestyle intervention fitted well with routine health-check consultations; however, acceptance and referral to the program was dependent on the level of facilitation provided by program coordinators. Respondents reported that patients engaged with the advice and strategies provided in the program, which helped them make lifestyle changes. Practice nurse involvement was important to sustaining implementation in general practice, while the lack of referral services for people at risk of developing vascular disease threatens maintenance of lifestyle changes as few respondents thought patients would continue lifestyle changes without long-term follow up. Lifestyle modification programs to prevent vascular disease are feasible in general practice but must be provided in a flexible format, such as being offered out of hours to facilitate uptake, with ongoing support and follow up to assist maintenance. The newly formed Medicare Locals may have an important role in facilitating lifestyle modification programs for this target group.

scholarly journals The iHealth-T2D study: Statistical analysis plan for a cluster randomised controlled trial with intensive family-based lifestyle modification programme to reduce type 2 diabetes risk amongst South Asians

2020 ◽  
Author(s):  
Mirthe Muilwijk ◽  
Marie Loh ◽  
Sara Mahmood ◽  
Saranya Palaniswamy ◽  
Samreen Siddiqui ◽  
...  
Keyword(s):  
Lifestyle Modification ◽  
South Asians ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Statistical Analysis Plan ◽  
Link Type ◽  
Family Based ◽  
Randomised Controlled

AbstractBackgroundSouth Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high-costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.MethodsThe iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. A total of 3,682 South Asian men and women with age between 40-70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥95cm in Sri Lanka, or ≥100cm in India, Pakistan and UK) and/or prediabetes (HbA1c ≥6.0%)] were included in the trial. Here we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after three years of follow-up after enrolment to the study, and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after one and three years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.DiscussionThe iHealth-T2D trial will provide evidence whether an intensive family-based lifestyle modification programme in South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/; ClinicalTrials.govNCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.

Process evaluation of a community-based diabetes prevention program in China: the Pathway to Health (PATH)

2019 ◽  
Vol 34 (5) ◽  
pp. 521-531
Author(s):  
Mark A Strand ◽  
Meizi He ◽  
Ryan Johnson ◽  
Judith Perry ◽  
Zenong Yin
Keyword(s):  
Process Evaluation ◽  
Program Implementation ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Study Participant ◽  
Diabetes Prevention Program ◽  
Work And Family ◽  
Lifestyle Changes ◽  
Family Responsibilities

Abstract High prevalence of diabetes and prediabetes has emerged as a concern in China. The Pathway to Health Program was designed to prevent type 2 diabetes onset in prediabetic women in a north China urban community. This process evaluation of a randomized controlled trial analysed participant surveys at the 6- and 12-month assessment times, participant weekly logs, class attendance records and post-study participant focus group results. The reported levels of participant engagement in physical activity (PA)-related behaviors were higher than diet-related behaviors at the 6-month assessment. The engagement in both PA- and diet-related behaviors declined during the 6-month follow-up period. Step counts from the participants’ pedometers indicated an increase in PA in the first 6 months of the intervention. Study participants expressed high levels of satisfaction with the intervention and increased their scores on diabetes-related knowledge. Conflicts with work and family responsibilities were the main barriers for missing health lessons, likely contributing to minimal weight loss. There was good fidelity in program implementation. Intensive lifestyle modification programs are difficult to sustain once the program is complete. A more structured 6-month follow-up phase may have provided needed support to enable participants to maintain their lifestyle changes.

Pharmacists in general practice: a qualitative process evaluation of the General Practice Pharmacist (GPP) study

2020 ◽  
Vol 37 (5) ◽  
pp. 711-718
Author(s):  
Oscar James ◽  
Karen Cardwell ◽  
Frank Moriarty ◽  
Susan M Smith ◽  
Barbara Clyne
Keyword(s):  
General Practice ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Qualitative Approach ◽  
Structured Interviews ◽  
Practice Staff ◽  
Practice Nurses ◽  
Practice Team ◽  
Prescribing Quality ◽  
Descriptive Qualitative

Abstract Background There is some evidence to suggest that pharmacists integrated into primary care improves patient outcomes and prescribing quality. Despite this growing evidence, there is a lack of detail about the context of the role. Objective To explore the implementation of The General Practice Pharmacist (GPP) intervention (pharmacists integrating into general practice within a non-randomized pilot study in Ireland), the experiences of study participants and lessons for future implementation. Design and setting Process evaluation with a descriptive qualitative approach conducted in four purposively selected GP practices. Methods A process evaluation with a descriptive qualitative approach was conducted in four purposively selected GP practices. Semi-structured interviews were conducted, transcribed verbatim and analysed using a thematic analysis. Results Twenty-three participants (three pharmacists, four GPs, four patients, four practice nurses, four practice managers and four practice administrators) were interviewed. Themes reported include day-to-day practicalities (incorporating location and space, systems and procedures and pharmacists’ tasks), relationships and communication (incorporating GP/pharmacist mode of communication, mutual trust and respect, relationship with other practice staff and with patients) and role perception (incorporating shared goals, professional rewards, scope of practice and logistics). Conclusions Pharmacists working within the general practice team have potential to improve prescribing quality. This process evaluation found that a pharmacist joining the general practice team was well accepted by the GP and practice staff and effective interprofessional relationships were described. Patients were less clear of the overall benefits. Important barriers (such as funding, infrastructure and workload) and facilitators (such as teamwork and integration) to the intervention were identified which will be incorporated into a pilot cluster randomized controlled trial.

scholarly journals Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045444
Author(s):  
Sophie Ansems ◽  
Marjolein Berger ◽  
Patrick van Rheenen ◽  
Karin Vermeulen ◽  
Gina Beugel ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Cluster Randomised Controlled Trial ◽  
Referral Rate ◽  
Faecal Calprotectin ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionChildren with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.Methods and analysisIn this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.Ethics and disseminationThe Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.Trial registration numberThe Netherlands Trial Register: NL7690 (Pre-results)

scholarly journals Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035895
Author(s):  
Danielle Mazza ◽  
Natalie Amos ◽  
Cathy J Watson ◽  
Kevin McGeechan ◽  
Marion Haas ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Accord Study ◽  
Contraceptive Choice ◽  
Long Acting ◽  
Randomised Controlled

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.

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