scholarly journals Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial

2013 ◽  
Vol 13 (1) ◽  
Author(s):  
Domingo Orozco-Beltran ◽  
◽  
Esther Ruescas-Escolano ◽  
Ana Isabel Navarro-Palazón ◽  
Alberto Cordero ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Health Care Organization ◽  
Care Organization ◽  
Multifactorial Intervention ◽  
Organization Model ◽  
Randomized Controlled

scholarly journals A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Julie Redfern ◽  
Genevieve Coorey ◽  
John Mulley ◽  
Anish Scaria ◽  
Lis Neubeck ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Risk Factor ◽  
Digital Health ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88–1.20] p = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97–2.03] p = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control, p = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control, p = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.

scholarly journals Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care (Preprint)

2018 ◽  
Author(s):  
Susan Fletcher ◽  
Janine Clarke ◽  
Samineh Sanatkar ◽  
Peter Baldwin ◽  
Jane Gunn ◽  
...  
Keyword(s):  
Mental Health ◽  
Primary Care ◽  
Health Care ◽  
General Practice ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Web Based ◽  
Recruitment Methods ◽  
Face To Face ◽  
Randomized Controlled

BACKGROUND E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. OBJECTIVE This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. METHODS Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. RESULTS Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. CONCLUSIONS Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice.

scholarly journals Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Gina Agarwal ◽  
Jessica Gaber ◽  
Julie Richardson ◽  
Dee Mangin ◽  
Jenny Ploeg ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Self Management ◽  
Diabetes Diagnosis ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of “Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management” (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Methods Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants—patients of an interprofessional primary care team—were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Results Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n = 20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. Conclusions Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. Trial registration ClinicalTrials.gov, NCT02715791. Registered 22 March 2016—retrospectively registered.

scholarly journals Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial

10.2196/17351 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e17351
Author(s):  
Jordi Piera-Jiménez ◽  
Marjolein Winters ◽  
Eva Broers ◽  
Damià Valero-Bover ◽  
Mirela Habibovic ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
The Netherlands ◽  
Controlled Trial ◽  
Cost Effectiveness Ratio ◽  
Cardiac Health ◽  
Randomized Controlled ◽  
New Generation

Background During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques. Objective This study aimed to provide evidence to understand the financial consequences of implementing the “Do Cardiac Health: Advanced New Generation Ecosystem” (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease. Methods The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities). Results The Do CHANGE 2 intervention was less costly in Spain (incremental cost was −€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan. Conclusions In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention. Trial Registration ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305

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