scholarly journals A Randomised Controlled Trial to Test the Effectiveness of Planning Strategies to Improve Medication Adherence in Patients with Cardiovascular Disease

2016 ◽  
Vol 9 (1) ◽  
pp. 106-129 ◽  
Author(s):  
Carine Meslot ◽  
Aurélie Gauchet ◽  
Martin S. Hagger ◽  
Nikos Chatzisarantis ◽  
Audrey Lehmann ◽  
...  
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.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e055930
Author(s):  
Constance P Fontanet ◽  
Niteesh K Choudhry ◽  
Wendy Wood ◽  
Ted Robertson ◽  
Nancy Haff ◽  
...  

IntroductionMedication adherence for patients with chronic conditions such as gout, a debilitating form of arthritis that requires daily medication to prevent flares, is a costly problem. Existing interventions to improve medication adherence have only been moderately effective. Habit formation theory is a promising strategy to improve adherence. The cue-reward-repetition principle posits that habits are formed by repeatedly completing an activity after the same cue and having the action rewarded every time. Over time, cues become increasingly important whereas rewards become less salient because the action becomes automatic. Leveraging the cue-reward-repetition principle could improve adherence to daily gout medications.Methods and analysisThis three-arm parallel randomised controlled trial tests an adaptive intervention that leverages the repetition cue-reward principle. The trial will began recruitment in August 2021 in Boston, Massachusetts, USA. Eligible patients are adults with gout who have been prescribed a daily oral medication for gout and whose most recent uric acid is above 6 mg/dL. Participants will be randomised to one of three arms and given electronic pill bottles. In the two intervention arms, participants will select a daily activity to link to their medication-taking (cue) and a charity to which money will be donated every time they take their medication (reward). Participants in Arm 1 will receive reminder texts about their cue and their charity reward amount will be US$0.50 per day of medication taken. Arm 2 will be adaptive; participants will receive a US$0.25 per adherent-day and no reminder texts. If their adherence is <75% 6 weeks postrandomisation, their reward will increase to US$0.50 per adherent-day and they will receive reminder texts. The primary outcome is adherence to gout medications over 18 weeks.Ethics and disseminationThis trial has ethical approval in the USA. Results will be published in a publicly accessible peer-reviewed journal.Trial registration numberNCT04776161


2021 ◽  
Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
James McVeigh ◽  
Andrew Mamo ◽  
Joseph Magdy ◽  
...  

BACKGROUND This is the first randomised controlled trial (RCT) of a mobile health intervention that combines telemonitoring and educational components for both acute coronary syndrome (ACS) and heart failure (HF) inpatients to prevent readmission. OBJECTIVE Objective: To evaluate the feasibility, efficacy and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care – TCC) plus usual care in patients being discharged from hospital after an ACS or HF admission, in comparison to usual care alone. METHODS Methods: In this pilot, 2-centre RCT, a smartphone app-based model of care (TeleClinical Care – TCC) was applied at discharge. The primary endpoint was the incidence of unplanned 30-day readmissions. Secondary endpoints included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure and physical activity daily, plus usual care. The devices automatically transmitted recordings to the patient’s smartphone and then subsequently to a central server. Abnormal readings were flagged by email to a monitoring team. Control participants received usual care. RESULTS Results: 164 hospital inpatients were randomised at the time of discharge (TCC n=81, control n = 83, mean age 61.5 years, 79% male, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P = .97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 vs. 41 readmissions, P = 0.015), including cardiac readmissions (11 vs. 25, P = .025), and higher rates of cardiac rehabilitation completion (39% vs. 18%, P = .025) and medication adherence (75% vs. 50%, P = .002). The average usability rating of the app was 4.5/5. The intervention cost AUD $6,028 per cardiac readmission saved. When modelled in a mainstream clinical setting, however, enrolment of 237 patients was projected to have the same healthcare expenditure compared to usual care, and enrolment of 500 patients was projected to save approximately AUD $100,000. CONCLUSIONS Conclusion: TCC was feasible and safe for ACS and HF inpatients. The incidence of 30-day readmissions was similar, however long-term benefits were demonstrated including fewer total readmissions over 6 months, improved medication adherence and improved cardiac rehabilitation completion. CLINICALTRIAL The study was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618001547235).


BMJ ◽  
2016 ◽  
pp. i2647 ◽  
Author(s):  
Chris Salisbury ◽  
Alicia O’Cathain ◽  
Clare Thomas ◽  
Louisa Edwards ◽  
Daisy Gaunt ◽  
...  

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