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Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Only one-third of hypertensive patients achieve and maintain blood-pressure control. This is attributed to low treatment adherence and has a negative impact on clinical outcomes. Adherence is multidimensional and involves aspects both related to patient characteristics and to the chronic nature of the disease. In this context, motivational interviewing has been proposed as an approach to foster patients' motivations to change their behavior for the benefit of their own health, thus providing more lasting behavioral changes. DESIGN AND METHODS:Single-center, parallel, randomized controlled trial with outcome-assessor blinding. This study will select adult patients (n?=?120) diagnosed with hypertension who receive regular follow-up in a specialized outpatient clinic. Patients will be randomly allocated across two groups: the intervention group will have appointments focused on motivational interviewing, while the control group will have traditional appointments. Patients will be monitored face-to-face, once monthly for six months. The primary outcomes will be a reduction of at least 8?mmHg in systolic blood pressure and changes in mean blood pressure measured by 24-h ambulatory blood pressure monitoring. Secondary outcomes include improvement of adherence to a low-sodium diet, adherence to self-care behaviors, regular use of antihypertensive medications, increase or maintenance of physical activity, weight reduction, evaluation of changes in daytime sleepiness, and cessation of smoking. DISCUSSION:This study shows an intervention strategy that will be tested and, if effective, warrant replication in monitoring of other chronic diseases. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02892929 . Registered on 24 August 2016.

SUBMITTER: Silveira LCJ

PROVIDER: S-EPMC6617897 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial.

Silveira Luana Claudia Jacoby LCJ Aliti Graziella Badin GB Da Silva Elisabeth Meyer EM Pimentel Ravi Pereira RP Gus Miguel M Rabelo-Silva Eneida Rejane ER

Trials 20190709 1

<h4>Background</h4>Only one-third of hypertensive patients achieve and maintain blood-pressure control. This is attributed to low treatment adherence and has a negative impact on clinical outcomes. Adherence is multidimensional and involves aspects both related to patient characteristics and to the chronic nature of the disease. In this context, motivational interviewing has been proposed as an approach to foster patients' motivations to change their behavior for the benefit of their own health, ...[more]

PMID: 31288854

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Project description:BackgroundThe nonpharmacological approach to diabetic control in patients with diabetes focuses on a healthy diet, physical activity, and self-management. Therefore, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns and include brief advice and counseling services. Within this context, motivational interviewing (MI) has proven to be effective in changing health behaviors for specific cases. However, stronger evidence is needed on the effectiveness of MI in treating chronic pathologies such as diabetes.ObjectiveThis study will obtain preliminary data on the impact of a nurse-led MI intervention in improving glycemic control, as well as clinical, psychosocial, and self-care outcomes for individuals with type 2 diabetes mellitus when compared with usual care, with the aim of improving diabetic control in patients with diabetes.MethodsAn open, two-arm, parallel, randomized controlled, pilot exploratory trial will be performed. Two government outpatient clinics in the New Territories West Cluster in Hong Kong will be involved. In total, 20 to 25 participants will be invited in each arm. Intervention participants will receive face-to-face MI interventions in addition to their usual care from the clinic. Control participants will only receive usual care. Outcomes are assessed at baseline, 6 months, and 12 months. The primary outcome measure is glycated hemoglobin levels. Secondary outcomes include blood pressure, BMI, hip and waist circumference, fasting blood, and psychosocial and self-care measures.ResultsThis study is currently underway with funding support from the Hong Kong College of Family Physician Research Seed Fund 2017.ConclusionsMI skills constitute the main strategies primary care nurses use on their patients. Having economical, simple, effective, and applicable techniques is essential for primary care professionals to help their patients change their lifestyle and improve their health. This study will provide scientific evidence on the effectiveness of MI. It will be performed with strict control over the data collection, ensuring the maintenance of therapeutic integrity.Trial registrationCentre for Clinical Research and Biostatistics CUHK_CCRB00614; https://tinyurl.com/v9awzk6.International registered report identifier (irrid)DERR1-10.2196/15709.

Project description:Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition.A sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation.This trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline.ClinicalTrials.gov NCT01188018.

Project description:BackgroundIt is known that making people change their habits is challenging. It is crucial to identify the most effective approach that general practitioners (GPs) should use to help their patients change unhealthy habits. The objective this study was to assess the efficacy of a multifactorial intervention based on Motivational Interviewing performed by general practitioners to enhance lipid levels in patients with dyslipidemia, as compared to standard care.MethodsA multicenter, controlled, randomized, cluster, two-parallel arm trial with a 12-month follow-up conducted in 25 community health centers of the Spanish. 38 GPs and 227 primary care patients with uncontrolled dyslipidemia were included in the trial. GPs performed an intervention based either on Motivational Interviewing (MI) or standard practice. Lipid levels were measured, and the control degree was analyzed based on the criteria of clinical guidelines.Results107 were assigned to the Experimental Group (EG) and 120 to the Control Group (CG). An overall improvement was achieved in total cholesterol levels (Mean Difference -MD- = -19.60; 95 % CI: -15.33 at -23.87 mg/dl; p < 0.001), LDL-cholesterol levels (MD = -13.78; 95 % CI: -9.77 at -17.79 mg/dl; p < 0.001) and triglycerides (MD = -19.14; CI 95 %: -11.29 at -26.99 mg/dl; p < 0.001). No differences were found between the two groups. However, when we assessed the degree of lipid control by combining cholesterol <200 mg/dl and LDL-cholesterol < 130 mg/dl parameters, it was observed that a higher percentage of patients achieved target figures in the EG versus CG (13.1 % vs. 5.0 %; adjusted OR = 5.77, 95 % CI: 1.67-19.91).ConclusionA Motivational Interviewing-based approach conducted by Primary Care physicians aimed at patients with dyslipidemia, achieved a significant reduction in all lipid parameters, cardiovascular risk, weight reduction and the adherence to the Mediterranean diet, similar to that obtained with the usual intervention and superior in the proportion of patients achieving combined lipid control goals and the level of physical exercise.Trial registrationthe trial is registered in ClinicalTrials.gov ( NCT01282190 ; January 21, 2011).

Project description:BACKGROUND:General medical hospitals provide care for a disproportionate share of patients who misuse substances. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance misuse. OBJECTIVE:To determine the effectiveness of three strategies for implementing motivational interviewing for substance misuse with general medical inpatients. DESIGN:Type 3 hybrid effectiveness-implementation randomized controlled trial (Clinical Trials.gov: NCT01825057). PARTICIPANTS:Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital. INTERVENTIONS:Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition). MAIN MEASURES:Primary outcomes were the percentage of study-eligible patients who received an interview for substance misuse and the integrity (adherence, competence) of the interviews. The secondary outcome was the percent of patient statements within the interviews that indicated motivation for reducing substance misuse. KEY RESULTS:20.5% of patients in the consult condition received an interview, compared to 0.8% (Hedge's g?=?1.49) and 3.0% (Hedge's g?=?1.26) in the respective workshop only and apprenticeship conditions (p?<?0.001). Motivational interviews in the consult condition were performed with more fundamental motivational interviewing adherence and competence than the other conditions. Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions. CONCLUSIONS:Providers' ability to place an order to have experts from the consultation-liaison service deliver a motivational interview was a more effective implementation strategy than a workshop or apprenticeship method for ensuring motivational interviewing is available to medical inpatients who misuse substances. TRIAL REGISTRY:NCT01825057.

Dataset Information

Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial.

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Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial.

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