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Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Hypertension is the premier modifiable risk factor for recurrent stroke. In sub-Saharan Africa (SSA) where the stroke burden is escalating, little is known about the role of behavioral interventions in enhancing blood pressure (BP) control after stroke. Our objective is to test whether an m-Health technology-enabled, nurse-led, multilevel integrated approach is effective in improving BP control among Ghanaian stroke patients within 1 month of symptom onset compared with standard of care. METHODS:This two-arm cluster randomized controlled feasibility pilot trial will involve 60 recent-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated into four clusters of 15 patients each per physician: two clusters in the intervention arm and two in the control arm. Patients in the intervention arm will receive a simple pillbox, a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake under nurse guidance for 3 months. Tailored motivational text messages will be delivered based upon levels of adherence to the medication intake. Both groups will be followed up for 6 months to compare BP control at months 3, 6 and 9 as primary outcome measure. Physicians assessing BP control will be blinded to arms into which patients are allocated. Secondary outcome measures will include medication adherence scores and Competence and Autonomous Self-regulation Scale scores. A qualitative study is planned after follow-up to explore the lived experiences of participants in the intervention arm. DISCUSSION:A feasible and preliminarily effective intervention would lead to a larger more definitive efficacy/effectiveness randomized controlled trial powered to look at clinical events, with the potential to reduce stroke-related morbidity and mortality in a low- to middle-income country. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02568137 , registered on 13 July 2015.

SUBMITTER: Sarfo FS

PROVIDER: S-EPMC5011977 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial.

Sarfo Fred Stephen FS Treiber Frank F Jenkins Carolyn C Patel Sachin S Gebregziabher Mulugeta M Singh Arti A Sarfo-Kantanka Osei O Saulson Raelle R Appiah Lambert L Oparebea Eunice E Ovbiagele Bruce B

Trials 20160905 1

<h4>Background</h4>Hypertension is the premier modifiable risk factor for recurrent stroke. In sub-Saharan Africa (SSA) where the stroke burden is escalating, little is known about the role of behavioral interventions in enhancing blood pressure (BP) control after stroke. Our objective is to test whether an m-Health technology-enabled, nurse-led, multilevel integrated approach is effective in improving BP control among Ghanaian stroke patients within 1 month of symptom onset compared with standa ...[more]

PMID: 27596244

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Project description:BACKGROUND:The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically. OBJECTIVE:The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient's transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions. METHODS:The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers' Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers' burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors' functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel. RESULTS:Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021. CONCLUSIONS:This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke. TRIAL REGISTRATION:ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/21799.

Project description:BackgroundSubstantial effort has been undertaken to improve the recruitment and retention of participants in stroke trials. African Americans are disproportionately under-represented in stroke clinical trials as well as clinical trials for other chronic disease conditions. To circumvent barriers to recruitment, clinical trial recruitment strategies used to recruit African Americans have focused on different aspects of community engagement.PurposeThis study examined a community-engaged, multi-phased tailored approach to recruiting African Americans with stroke. The recruitment approach described was designed to support the Community Based Intervention under Nurse Guidance after Stroke (CINGS) trial, part of the Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM) Center established to explore stroke disparities.MethodsA multiple-phased recruitment approach was undertaken and involved a recruitment planning phase and a recruitment phase. The recruitment planning phase involved the use of focus groups designed to explore barriers and facilitators of stroke recovery. The active recruitment phase included multiple strategies with ongoing evaluation.ResultsInformation gained from focus groups offered insights into strategies critical to recruiting African Americans with stroke for behavioral research during the early recovery period. Strategies to enhance the identification of and recruitment of potential participants included use of: a) a hospital system stroke database, b) system-wide friendly visits/warm handoff approaches, c) electronic health record, d) associated external sites and e) protocol adjustments.ConclusionsDeveloping tailored approaches to curtail barriers to research participation is critical for increasing the probability of reaching African American study participant recruitment and retention goals. Research teams may require training in community-engagement research strategies essential for obtaining achieving target recruitment goals.

Project description:BackgroundStroke survivors are at a substantially higher risk for adverse vascular events driven partly by poorly controlled vascular risk factors. Mobile health interventions supported by task shifting strategies have been feasible to test in small pilot trials in low-income settings to promote vascular risk reduction after stroke. However, real-world success and timely implementation of such interventions remain challenging, necessitating research to bridge the know-do gap and expedite improvements in stroke management. The Phone-based Interventions under Nurse Guidance after Stroke (PINGS-II) is a nurse-led mHealth intervention for blood pressure control among stroke survivors, currently being assessed for efficacy in a hybrid clinical trial across 10 hospitals in Ghana compared with usual care. This protocol aims to assess implementation outcomes such as feasibility, appropriateness, acceptability, fidelity, cost and implementation facilitators and barriers of the PINGS-II intervention.Methods and analysisThis study uses descriptive mixed methods. Qualitative data to be collected include in-depth interviews and FGDs with patients who had a stroke on the PINGS-II intervention, as well as key informant interviews with medical doctors and health policy actors (implementation context, barriers and facilitators). Data will be analysed by thematic analysis. Quantitative data sources include structured questionnaires for clinicians (feasibility, acceptability and appropriateness), and patients who had a stroke (fidelity and costs). Analysis will include summary statistics like means, medians, proportions and exploratory tests of association including χ2 analysis.Ethics and disseminationEthics approval was obtained from the Committee for Human Research Publication and Ethics at the Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. Voluntary written informed consent will be obtained from all participants. All the rights of the participants and ethical principles guiding scientific research shall be adhered to. Findings from the study will be presented in scientific conferences and published in a peer-reviewed scientific journal. A dissemination meeting will be held with relevant agencies of the Ghana Ministry of Health, clinicians, patient group representatives, and non-governmental organisations.

Project description:BACKGROUND:Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)-based interventions can help individuals quit smoking. OBJECTIVE:The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. METHODS:A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change-enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments' current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. RESULTS:Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. CONCLUSIONS:Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. TRIAL REGISTRATION:ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/12511.

Project description:BACKGROUND:Heavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown. METHODS/DESIGN:We will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (?4 drinks for women; ?5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months. DISCUSSION:This study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change. TRIAL REGISTRATION:Clinicaltrials.gov NCT01688245.

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Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial.

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Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial.

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