Dataset Information

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial.

ABSTRACT:

Background and purpose

Stroke exacts an immense toll in sub-Saharan Africa where there are few resources, and stroke prevention research is limited. The aim of this study is to test the feasibility and preliminary efficacy of an m-Health technology-enabled, nurse-guided intervention in improving blood pressure (BP) control among Ghanaian stroke patients within 1 month of symptom onset.

Methods

We conducted a 2-arm cluster pilot randomized controlled trial involving 60 recent stroke survivors encountered within a single tertiary medical system in Ghana. Subjects in the intervention arm (n=30) received a Blue-toothed UA-767Plus BT BP device and smartphone for monitoring and reporting BP measurements and medication intake for 3 months compared with standard of care (n=30). Primary outcome measure was systolic BP <140 mm Hg at month 3; secondary outcomes included medication adherence and autonomous self-regulation. Analysis accounting for clustering was made using generalized linear mixed model by intention to treat.

Results

Mean±SD age was 55±13 years, 65% male. Systolic BP <140 mm Hg at month 3 was found in 20/30 subjects (66.7%) in the intervention arm versus 14/30 subjects (46.7%) in the control arm (P=0.12). Medication possession ratio scores at month 3 were better in the intervention (0.88±0.40) versus control (0.64±0.45) arm (P=0.03). One subject in control arm died from a recurrent hemorrhagic stroke.

Conclusions

It is feasible to conduct an m-Health-based, nurse-guided BP control intervention among recent stroke patients in sub-Saharan Africa. We observed a potential signal of efficacy with the intervention, which will need to be tested in a future large definitive study.

Clinical trial registration

URL: https://www.clinicaltrials.gov. Unique identifier: NCT02568137.

SUBMITTER: Sarfo F

PROVIDER: S-EPMC5742065 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Publications

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial.

Sarfo Fred F Treiber Frank F Gebregziabher Mulugeta M Adamu Sheila S Patel Sachin S Nichols Michelle M Awuah Dominic D Sakyi Asumadu A Adu-Darko Nyantakyi N Singh Arti A Tagge Raelle R Carolyn Jenkins J Ovbiagele Bruce B

Stroke 20171208 1

<h4>Background and purpose</h4>Stroke exacts an immense toll in sub-Saharan Africa where there are few resources, and stroke prevention research is limited. The aim of this study is to test the feasibility and preliminary efficacy of an m-Health technology-enabled, nurse-guided intervention in improving blood pressure (BP) control among Ghanaian stroke patients within 1 month of symptom onset.<h4>Methods</h4>We conducted a 2-arm cluster pilot randomized controlled trial involving 60 recent strok ...[more]

PMID: 29222227

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Project description:BackgroundHypertension 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.MethodsThis 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.DiscussionA 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 registrationClinicalTrials.gov Identifier: NCT02568137 , registered on 13 July 2015.

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:Despite the increasing breast cancer incidence and mortality rates, Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States. Mobile health (mHealth), defined as the delivery of health care information or services through mobile communication devices, has been utilized to successfully improve a variety of health outcomes.This study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women, an underserved community.Using a randomized controlled trial design, 120 Korean American women aged 40 to 77 years were recruited and randomly assigned to either the mMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group (n=60) to receive a printed brochure. Outcome measures included knowledge, attitudes, and beliefs about breast cancer screening, readiness for mammography, and mammogram receipt. The feasibility and acceptability of the mMammogram intervention was also assessed.The intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines (P=.01). The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group. A significantly higher proportion of women who received the mMammogram intervention (75%, 45/60) completed mammograms by the 6-month follow-up compared with the control group (30%, 18/60; P<.001). In addition, the intervention group rated satisfaction with the intervention (P=.003), effectiveness of the intervention (P<.001), and increase of knowledge on breast cancer and screenings (P=.001) significantly higher than the control group.A mobile phone app-based intervention combined with health navigator service was a feasible, acceptable, and effective intervention mechanism to promote breast cancer screening in Korean American immigrant women. A flexible, easily tailored approach that relies on recent technological advancements can reach underserved and hard-to-recruit populations that bear disproportionate cancer burdens.Clinicaltrials.gov NCT01972048; https://clinicaltrials.gov/show/NCT01972048 (Archived by WebCite at https://clinicaltrials.gov/archive/NCT01972048/2013_10_29).

Project description:IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysisThis is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.Trial registration numberChiCTR2100050853.

Project description:Valid, reliable behavioral data and contextually meaningful interventions are necessary for improved health outcomes. Ecological Momentary Assessment and Intervention (EMAI), which collects data as behaviors occur to deliver real-time interventions, may be more accurate and reliable than retrospective methods. The rapid expansion of mobile technologies in low-and-middle-income countries allows for unprecedented remote data collection and intervention opportunities. However, no previous studies have trialed EMAI in sub-Saharan Africa. We assessed EMAI acceptability and feasibility, including participant retention and response rate, in a prospective, parallel group, randomized pilot trial in Rakai, Uganda comparing behavioral outcomes among adults submitting ecological momentary assessments (EMA) versus EMAI. After training, participants submitted EMA data on five nutrition and health risk behaviors over a 90-day period using a smartphone-based application utilizing prompt-based, participant-initiated, and geospatial coordinate data collection, with study coordinator support and incentives for >50% completion. Included behaviors and associated EMAI-arm intervention messages were selected to pilot a range of EMAI applications. Acceptability was measured on questionnaires. We estimated the association between high response rate and participant characteristics and conducted thematic analysis characterizing participant experiences. Study completion was 48/50 participants. Median prompt response rate was 66.5% (IQR: 60.0%-78.6%). Prior smartphone app use at baseline (aPR 3.76, 95%CI: 1.16-12.17, p = 0.03) and being in the intervention arm (aPR 2.55, 95% CI: 1.01-6.44, p = 0.05) were significantly associated with the top response rate quartile (response to >78.6% of prompts). All participants submitted self-initiated reports, covering all behaviors of interest, including potentially sensitive behaviors. Inconsistent phone charging was the most reported feasibility challenge. In this pilot, EMAI was acceptable and feasible. Response rates were good; additional strategies to improve compliance should be investigated. EMAI using mobile technologies may support improved behavioral data collection and intervention approaches in low and middle-income settings. This approach should be tested in larger studies.

Dataset Information

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial.

Background and purpose

Methods

Results

Conclusions

Clinical trial registration

Publications

PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke): Interim Results of a Pilot Randomized Controlled Trial.

Similar Datasets

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