scholarly journals Text messages for primary prevention of cardiovascular disease: the TextMe2 randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e036767
Author(s):  
Harry Klimis ◽  
Aravinda Thiagalingam ◽  
Clara K Chow

IntroductionMobile health may be an effective means of delivering customised individually directed health promotion interventions for cardiovascular disease (CVD) primary prevention. The aim of this study is to evaluate the effectiveness of a lifestyle-focused text messaging programme for primary CVD prevention.Methods and analysisSingle-blind randomised controlled trial with 6 months’ follow-up in 246 patients with moderate-high absolute cardiovascular risk and without coronary heart disease recruited from a rapid access cardiology clinic. Participants will be randomised to receive either usual care or TextMe2 (text message-based prevention programme). The TextMe2 programme provides support, motivation and education on five topics: diet, physical activity, smoking, general cardiovascular health and medication adherence, and is delivered in four text messages per week over 6 months. The primary outcome is change in the proportion of patients who have three or more of five key modifiable risk factors that are uncontrolled (low-density lipoprotein >2.0 mmol/L, systolic blood pressure >140 mm Hg, body mass index >24.9 kg/m2, physical activity (less than the equivalent of 150 min of moderate intensity each week), current smoker). Secondary outcomes are changes in single biomedical risk factors, behavioural risk factors, quality of life, depression/anxiety scores, medication adherence, cardiovascular health literacy and hospital readmissions/representations. Analysis will be according to the intention-to-treat principle and full statistical analysis plan developed prior to data lock.Ethics and disseminationThis study has been approved by the Western Sydney Local Health District Human Research Ethics Committee at Westmead (AU/RED/HREC/17/WMEAD/186). Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12618001153202.

2018 ◽  
Vol 52 (4) ◽  
pp. 1800063 ◽  
Author(s):  
Ane Arbillaga-Etxarri ◽  
Elena Gimeno-Santos ◽  
Anael Barberan-Garcia ◽  
Eva Balcells ◽  
Marta Benet ◽  
...  

There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease (COPD). We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients.This randomised controlled trial (NCT01897298) allocated 407 COPD patients from primary and hospital settings 1:1 to usual care (n=205) or Urban Training (n=202). Urban Training consisted of a baseline motivational interview, advice to walk on urban trails designed for COPD patients in outdoor public spaces and other optional components for feedback, motivation, information and support (pedometer, calendar, physical activity brochure, website, phone text messages, walking groups and a phone number). The primary outcome was 12-month change in steps·day−1 measured by accelerometer.Efficacy analysis (with per-protocol analysis set, n=233 classified as adherent to the assigned intervention) showed adjusted (95% CI) 12-month difference +957 (184–1731) steps·day−1 between Urban Training and usual care. Effectiveness analysis (with intention-to-treat analysis set, n=280 patients completing the study at 12 months including unwilling and self-reported non-adherent patients) showed no differences between groups. Leg muscle pain during walks was more frequently reported in Urban Training than usual care, without differences in any of the other adverse events.Urban Training, combining behavioural strategies with unsupervised outdoor walking, was efficacious in increasing physical activity after 12 months in COPD patients, with few safety concerns. However, it was ineffective in the full population including unwilling and self-reported non-adherent patients.


2018 ◽  
Vol 78 (2) ◽  
pp. 226-237 ◽  
Author(s):  
Susan L Dunn ◽  
Lorraine B Robbins ◽  
Sandi W Smith ◽  
Rajiv Ranganathan ◽  
Holli A DeVon ◽  
...  

Objective: Hopelessness is present in 27% of patients with ischaemic heart disease (IHD), can persist for 12 months and is associated with lack of physical activity (PA). No interventions have been tested to increase PA in IHD patients who report hopelessness. This study evaluated the feasibility of conducting a randomised controlled trial to investigate the effectiveness of the Heart Up! intervention, designed to reduce hopelessness through enhanced PA in IHD patients. It was hypothesised that increased PA would be identified in the intervention group. Setting: Patients were recruited from a large teaching hospital in the Midwestern USA. Data collection occurred in the patient’s home at 1 and 8 weeks after hospital discharge. Methods: A three-group design was used. Eligible patients were randomised to (1) motivational social support (MSS) from a nurse, (2) MSS from a nurse with social support from a significant other support (SOS) or (3) control. MSS-only and MSS-SOS recipients received motivational interviewing followed by 6 weeks of social support text messages from a nurse. MSS-SOS participants additionally received social support text messages from a significant other. Control participants received the usual care. Feasibility outcomes included recruitment and retention rates, patient acceptability and patient satisfaction. An accelerometer measured PA. Results: Of the 156 patients screened for the study, 43 met the inclusion criteria. Of eligible patients, 69.8% ( n = 30) enrolled and 67% ( n = 20) completed the study. Patients in the MSS and MSS-SOS groups expressed satisfaction with the intervention components (86% with motivational interviewing, 77% with nurse texts and 100% with significant other texts). Although differences were not statistically significant, a medium effect size for change in PA was identified in the MSS-SOS group compared to the other two groups. Conclusion: Study findings demonstrate the feasibility of the Heart Up! intervention and support testing its efficacy in a randomised controlled trial.


BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018302 ◽  
Author(s):  
Xiqian Huo ◽  
Erica S Spatz ◽  
Qinglan Ding ◽  
Paul Horak ◽  
Xin Zheng ◽  
...  

IntroductionMobile health interventions have the potential to promote risk factor management and lifestyle modification, and are a particularly attractive approach for scaling across healthcare systems with limited resources. We are conducting two randomised trials to evaluate the efficacy of text message-based health messages in improving secondary coronary heart disease (CHD) prevention among patients with or without diabetes.Methods and analysisThe Cardiovascular Health And Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study are multicentre, single-blind, randomised controlled trials of text messaging versus standard treatment with 6 months of follow-up conducted in 37 hospitals throughout 17 provinces in China. The intervention group receives six text messages per week which target blood pressure control, medication adherence, physical activity, smoking cessation (when appropriate), glucose monitoring and lifestyle recommendations including diet (in CHAT-DM). The text messages were developed based on behavioural change techniques, using models such as the information-motivation-behavioural skills model, goal setting and provision of social support. A total sample size of 800 patients would be adequate for CHAT Study and sample size of 500 patients would be adequate for the CHAT-DM Study. In CHAT, the primary outcome is the change in systolic blood pressure (SBP) at 6 months. Secondary outcomes include a change in proportion of patients achieving a SBP <140 mm Hg, low-density lipoprotein cholesterol (LDL-C), physical activity, medication adherence, body mass index (BMI) and smoking cessation. In CHAT-DM, the primary outcome is the change in glycaemic haemoglobin (HbA1C) at 6 months. Secondary outcomes include a change in the proportion of patients achieving HbA1C<7%, fasting blood glucose, SBP, LDL-C, BMI, physical activity and medication adherence.Ethics and disseminationThe central ethics committee at the China National Center for Cardiovascular Disease and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. Results will be disseminated via usual scientific forums including peer-reviewed publications.Trial registration numberCHAT (NCT02888769) and CHAT-DM (NCT02883842); Pre-results.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e036780
Author(s):  
Daniel Mcintyre ◽  
Aravinda Thiagalingam ◽  
Clara Chow

IntroductionPatients with cardiovascular disease (CVD) frequently attend outpatient clinics and spend a significant amount of time in waiting rooms. Currently, this time is poorly used. This study aims to investigate whether providing CVD and cardiopulmonary resuscitation (CPR) education to waiting patients in a cardiology clinic of a large referral hospital improves motivation to change health behaviours, CPR knowledge, behaviours and clinic satisfaction post clinic, and whether there is any impact on reported CVD lifestyle behaviours or relevant CPR outcomes at 30 days.Methods and analysisRandomised controlled trial with parallel design to be conducted among 330 patients in the waiting room of a chest pain clinic in a tertiary referral hospital. Intervention (n=220) participants will receive a tablet-delivered series of educational videos catered to self-reported topics of interest (physical activity, blood pressure, diet, medications, smoking and general health) and level of health knowledge. Control (n=110) participants will receive usual care. In a substudy, intervention participants will be randomised 1:1 to receive an extra video on CPR or no extra video. The primary outcome will be the proportion of intervention and control participants who report high motivation to improve physical activity, diet and blood pressure monitoring at end of clinic. The primary outcome of the CPR study will be confidence to perform CPR post clinic. Secondary analysis will examine impact on clinic satisfaction, lifestyle behaviours, CPR knowledge and willingness to perform CPR post clinic and at 30-day follow-up.Ethics and disseminationEthics approval has been received from the Western Sydney Local Health District Human Research Ethics Committee. All patients will provide informed consent via a tablet-based eConsent framework. Study results will be disseminated via the usual channels including peer-reviewed publications and presentations at national and international conferences.Trial registration numberANZCTR12618001725257.


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