Dataset Information

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

ABSTRACT:

Background

Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system-based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control.

Objective

The mGlide randomized controlled trial is a National Institutes of Health-funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison.

Methods

We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis.

Results

To date, we have randomized 107 participants (54 intervention, 53 control).

Conclusions

This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations.

Trial registration

Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271.

International registered report identifier (irrid)

DERR1-10.2196/25424.

SUBMITTER: Lakshminarayan K

PROVIDER: S-EPMC7870345 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

Lakshminarayan Kamakshi K Murray Thomas A TA Westberg Sarah M SM Connett John J Overton Val V Nyman John A JA Culhane-Pera Kathleen A KA Pergament Shannon L SL Drawz Paul P Vollbrecht Emily E Xiong Txia T Everson-Rose Susan A SA

JMIR research protocols 20210125 1

<h4>Background</h4>Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system-based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control.<h4>Objective</h4>The mGlide randomized controlled trial is a Natio ...[more]

PMID: 33492231

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Project description:BackgroundIn the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP's safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence.ObjectiveThe goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior.MethodsThis study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60).ResultsInstitutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing.ConclusionsThis app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings.Trial registrationClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr.International registered report identifier (irrid)DERR1-10.2196/18640.

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Project description:BACKGROUND:High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. OBJECTIVE:This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. METHODS:In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. RESULTS:The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. CONCLUSIONS:This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. TRIAL REGISTRATION:ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/11282.

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Dataset Information

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

Similar Datasets

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