scholarly journals Cardiac rehabilitation after acute coronary syndrome comparing adherence and risk factor modification in a community-based shared care model versus hospital-based care in a randomised controlled trial with 12 months of follow-up

2016 ◽  
Vol 16 (4) ◽  
pp. 334-343 ◽  
Author(s):  
Jannik B Bertelsen ◽  
Jens Refsgaard ◽  
Helle Kanstrup ◽  
Søren P Johnsen ◽  
Ina Qvist ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Care Model ◽  
Community Based ◽  
Risk Factor Modification ◽  
Coronary Syndrome ◽  
Shared Care Model ◽  
Model Versus ◽  
Randomised Controlled ◽  
Factor Modification

scholarly journals Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial)

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Raymond Javan Chan ◽  
Jon Emery ◽  
Katharine Cuff ◽  
Laisa Teleni ◽  
Camilla Simonsen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
General Practitioners ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Shared Care ◽  
Care Model ◽  
Follow Up Care ◽  
Shared Care Model ◽  
Randomised Controlled

Abstract Background Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up. Methods We describe a protocol for a phase II, randomised controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early-stage breast cancer will be randomised to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e. EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer centre specialists (i.e. surgeons and oncologists) and general practitioners. The primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy—Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events. Discussion The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12619001594112. Registered on 19 November 2019

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial

PLoS Medicine ◽  
2019 ◽  
Vol 16 (10) ◽  
pp. e1002936 ◽  
Author(s):  
Eik Dybboe Bjerre ◽  
Thomas Hindborg Petersen ◽  
Anders Bojer Jørgensen ◽  
Christoffer Johansen ◽  
Peter Krustrup ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Community Based ◽  
Randomised Controlled

scholarly journals Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047067
Author(s):  
Pushpanjali Shakya ◽  
Archana Shrestha ◽  
Biraj Man Karmacharya ◽  
Abha Shrestha ◽  
Bård Eirik Kulseng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetes Prevention ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Community Based ◽  
Prevention Education ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionEvidence suggests that diabetes burden can be reduced by implementing early lifestyle intervention programmes in population with pre-diabetes in high-income countries. However, little is known in developing nations like Nepal. This study aims to assess effectiveness of community-based Diabetes Prevention Education Program (DiPEP) on haemoglobin A1c (HbA1c) level, proportion of pre-diabetes reverting to normoglycaemia, diet, physical activity, weight reduction, diabetes knowledge and health literacy after 6 months of follow-up. Furthermore, we will also conduct qualitative studies to explore experiences of participants of intervention sessions and perception of healthcare workers/volunteers about DiPEP.Methods and analysesThis is a community-based two-arm, open-label, cluster randomised controlled trial. We will randomise 14 clusters into intervention arm and control arm. Estimated total sample size is 448. We will screen individuals without diabetes, aged 18–64 years, and permanent residents of study sites. HbA1c test will be only performed if both Indian Diabetes Risk Score and random blood sugar value are ≥60 and 140–250 mg/dL, respectively. At baseline, participants in intervention arm will receive DiPEP package (including intensive intervention classes, diabetes prevention brochure, exercise calendar and food record booklet), and participants in control arm will be provided only with diabetes prevention brochure. The change in outcome measures will be compared between intervention to control arm after 6 months of follow-up by linear mixed models. Also, we will conduct individual interviews among participants and healthcare workers as part of a qualitative study. We will use thematic analysis to analyse qualitative data.Ethics and disseminationRegional Committee for Medical and Health Research Ethics, Norway; Nepal Health Research Council, Nepal and Institutional Review Committee, Kathmandu University School of Medical Sciences have approved the study. The DiPEP package can be implemented in other communities of Nepal if it is effective in preventing diabetes.Trial registration numberNCT04074148, 2019/783.

scholarly journals An Application of PRECIS-2 to Evaluate Trial Design in a Pilot Cluster Randomised Controlled Trial of a Community-based Smoking Cessation Intervention for Women Living in Disadvantaged Areas of Ireland

2021 ◽  
Author(s):  
Catherine Darker ◽  
Kirsty Loudon ◽  
Nicola O'Connell ◽  
Stefania Castello ◽  
Emma Burke ◽  
...  
Keyword(s):  
Trial Design ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Cluster Randomised Controlled Trial ◽  
Community Based ◽  
Team Members ◽  
Disadvantaged Communities ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background “We Can Quit2” (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of ‘We Can Quit’ (WCQ), a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised ‘enhanced usual care’ offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under ‘real world’ conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT).Methods The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: Eligibility, Recruitment, Setting, Organisation, Flexibility-Delivery, Flexibility-Adherence, Follow-up, Primary Outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. Results Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Recruitment to trial was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. Conclusions PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. Trial registration: This trial is registered with the ISRCTN registry (No. 74721694), available at https://doi.org/10.1186/ISRCTN74721694

scholarly journals The effect of the Continuous Care Model on treatment adherence in patients with myocardial infarction: a randomised controlled trial

2020 ◽  
Vol 25 (1) ◽  
pp. 54-65
Author(s):  
Mohammad Ali Zakeri ◽  
Zohreh Khoshnood ◽  
Mahlagha Dehghan ◽  
Farokh Abazari
Keyword(s):  
Myocardial Infarction ◽  
Randomised Controlled Trial ◽  
Treatment Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Care Model ◽  
Continuous Care ◽  
Randomised Controlled

Background Adherence to treatment is one of the behaviours associated with successful outcomes following a myocardial infarction, which leads to successful treatment in the disease. Aims This study aimed to investigate the effect of the Continuous Care Model (CCM) on treatment adherence in patients with myocardial infarction. Methods This was a randomised controlled trial performed on 82 patients with myocardial infarction. Convenience sampling was used to select the participants, and then they were allocated into two groups by the stratified random method. In the intervention group, a CCM was implemented. In the intervention group, 4–6 educational sessions (1–2 h) were conducted during one month in the form of spoken questions and answers about the presented subjects. The control group received routine care. A questionnaire of demographic information and treatment adherence was completed by samples in the two groups, intervention and control, before and immediately after training and after follow-up. Results The results of this study showed that treatment adherence was significantly higher in the intervention group than in the control group immediately after training and after the follow-up phase (three months) ( p < 0.001). Also, diet, drug and physical activity adherence were significantly higher in the intervention group than in the control group immediately after training and after follow-up ( p < 0.001). Conclusions Implementation of CCM led to an increase in adherence to the treatment in patients with myocardial infarction. Therefore, it is suggested that this model could be used as a nursing intervention to increase treatment adherence in cardiac-rehabilitation programmes.

scholarly journals Implementing a Nurse-Enabled, Integrated, Shared-Care Model Involving Specialists and General Practitioners in Breast Cancer Post-Treatment Follow-Up: A Study Protocol for a Phase II Randomised Controlled Trial (The EMINENT Trial)

2020 ◽  
Author(s):  
Raymond Chan ◽  
Jon Emery ◽  
Katharine Cuff ◽  
Laisa Teleni ◽  
Camilla Simonsen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
General Practitioners ◽  
Controlled Trial ◽  
Shared Care ◽  
Trial Registration ◽  
Cancer Center ◽  
Care Model ◽  
Follow Up Care ◽  
Shared Care Model

Abstract Background: Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer center specialists and community-based general practitioners for early breast cancer post-treatment follow-up.Methods: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early stage breast cancer will be randomized to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e., EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer center specialists (i.e., surgeons and oncologists) and general practitioners. Primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy-Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity and sedentary behaviors; financial toxicity; adherence; health resource utilization; and adverse events.Discussion: The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system.Trial registration: Trial registration: Australia and New Zealand Clinical Trials Registry, ACTRN12619001594112). Registered 19 November 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378690&isReview=true.

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