Dataset Information

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial.

ABSTRACT: Background: Poor medication adherence is a limitation in the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs. Purpose: To examine the process and effect of a nurse-led, web-based intervention based on behavioral change strategies to improve medication adherence in patients with CVD. Patients and methods: In this single-center, prospective, controlled clinical trial, cardiovascular patients were assigned to usual care, usual care plus a personalized website, or usual care plus a personalized website and personal consultations. Primary outcome was the level of adherence to cardiovascular medication. Data collection occurred between October 2011 and January 2015. Results: In total, 419 patients were randomized. Just 77 patients logged on the website and half of the invited patients attended the group consultation. Due to the limited use of the website, we combined the results of usual care and the usual care plus website group in one group (usual care) and compared these with the results of the group which received the nurse intervention (intervention group). No significant difference in adherence between the usual care group and the intervention group was observed. The adherence level in the usual care group was 93%, compared to 89% in the intervention group (p=0.08). 29% (usual care) and 31% (intervention group) of the patients showed a low adherence according to the Modified Morisky Scale® (p-value=0.94). The mean necessity concern differential was 3.8 with no differences between the two studied groups (mean 3.8 vs mean 3.9, p-value =0.86). Conclusion: Our intervention program did not show an effect. This could indicate that structured usual care provided to all cardiovascular patients already results in high medication adherence or that shortly after a cardiovascular event adherence is high. It could also indicate that the program did not have enough impact because there was not enough compliance with the intervention protocol. Trial registration: ID number NCT01449695, approved May 2011.

SUBMITTER: Sieben A

PROVIDER: S-EPMC6537037 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial.

Sieben Angelien A van Onzenoort Hein Aw HA van Dulmen Sandra S van Laarhoven Cjhm C Bredie Sebastian Jh SJ

Patient preference and adherence 20190523

Background: Poor medication adherence is a limitation in the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs. Purpose: To examine the process and effect of a nurse-led, web-based intervention based on behavioral change strategies to improve medication adherence in patients with CVD. Patients and methods: In this single-center, prospective, controlled clinical trial, cardiovascular patients were assigned to usual c ...[more]

PMID: 31213778

Similar Datasets

Project description:BackgroundNearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral "nudges" using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.MethodsThe Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.DiscussionThe primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment.Trial registrationClinicalTrials.gov NCT03973931 . Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

Project description:BackgroundMobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease.ObjectiveThis study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks.MethodsA two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks.ResultsParticipants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups.ConclusionsText4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398.International registered report identifier (irrid)RR2-10.1186/s13063-018-2468-z.

Project description:BackgroundStroke is a major cause of morbidity and mortality, especially in low and middle income countries. Medical management is the mainstay of therapy to prevent recurrence of stroke. Current estimates are that only 1 in 6 patients have perfect adherence to medication schedules. Using SMS (Short Messaging Service) as reminders to take medicines have been used previously for diseases such as diabetes and HIV with moderate success. We aim to explore the effectiveness and acceptability of SMS in increasing adherence to medications in patients with stroke.MethodsThis will be a randomized, controlled, assessor blinded single center superiority trial. Adult participants with access to a cell phone and a history of stroke longer than 1 month on multiple risk modifying medications will be selected from Neurology and Stroke Clinic. They will be randomized into two parallel groups in a 1:1 ratio via block technique with one group receiving the standard of care as per institutional guidelines while the parallel group receiving SMS reminders for each dose of medicine in addition to the standard of care. In addition intervention group will receive messages for lifestyle changes, medication information, risk factors and motivation for medication adherence. These will bemodeled on Social Cognitive Theory and Health Belief Model and will be categorized by Michies Taxonomy of Behavioral Change Communication. Patient compliance to medicines will be measured at baseline and then after 2 months in each group by using the Morisky Medication Adherence Scale. The change in compliance to medication regimen after the intervention and the difference between the two groups will be used to determine the effectiveness of SMS reminders as a tool to increase medication compliance. The acceptability of the SMS will be determined by a tool designed for this study whose attributes are based Rogers Diffusion of innovation theory. A sample size of 86 participants in each arm will be sufficient to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % between the two groups; using an attrition rate of 15 %, 200 participants in all will be randomized.DiscussionThe SMS for Stroke Study will provide evidence for feasibility and effectiveness of SMS in improving post stroke medication adherence in an LMIC setting.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT01986023 11 /11/2013.

Project description:BackgroundOlder patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity.MethodsThe study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients' diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention.DiscussionThis study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients' adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings.Trial registrationThe trial is registered at ChiCTR.org.cn ( ChiCTR2000030011 ; date February 19, 2020).

Project description:Introduction/objectivesAdherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important that interventions are developed to address this important health behavior issue. The aim of the present study was to design and evaluate a theory-based intervention to improve the medication adherence (primary outcome) among rheumatoid arthritis patients.MethodsThe study adopted a pre-registered randomized controlled trial design. Rheumatoid arthritis patients were recruited from two University teaching hospitals in Qazvin, Iran from June 2018 to May 2019 and randomly assigned to either an intervention group (n = 100) or a treatment-as-usual group (n = 100). The intervention group received a theory-based intervention designed based on the theoretical underpinnings of the health action process approach (HAPA). More specifically, action planning (making detailed plans to follow medication regimen), coping planning (constructing plans to overcome potential obstacles that may arise in medication adherence), and self-monitoring (using a calendar to record medication adherence) of the HAPA has been used for the treatment. The treatment-as-usual group received standard care.ResultsData analysis was conducted based on the principle of intention to treat. Using a linear mixed-effects model (adjusted for age, sex, medication prescribed, and body mass index), the results showed improved medication adherence scores in the intervention group (loss to follow-up = 16) compared to the treatment-as-usual group (loss to follow-up = 12) at the 3-month (coefficient = 3.9; SE = 0.8) and 6-month (coefficient = 4.5; SE = 0.8) follow-up. Intervention effects on medication adherence scores were found to be mediated by some of the theory-based HAPA variables that guided the study.ConclusionThe results of the present study support the use of a theory-based intervention for improving medication adherence among rheumatoid arthritis patients, a group at-risk of not adhering to medication regimens. TRIAL REGISTRATION (IN IRANIAN REGISTRY OF CLINICAL TRIALS): irct.ir, IRCT20180108038271N1 Key Points • Theoretical underpinnings of the health action process approach are useful to improve medication adherence for RA patients.

Dataset Information

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial.

Publications

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets