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A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial.

ABSTRACT: A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention's effectiveness. This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962.

SUBMITTER: Payne Riches S

PROVIDER: S-EPMC8569539 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. The country needs novel, large-scale, and sustainable interventions to improve hypertension control. We report the 12 month follow-up results of a cluster randomized feasibility trial in Hung Yen province, Vietnam, which evaluated the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" and a didactic intervention. METHODS:The storytelling intervention included stories in the patients' own words about coping with hypertension and didactic content about the importance of healthy lifestyle behaviors in controlling elevated blood pressure levels. The didactic intervention included only didactic content, which were general recommendations for managing several important risk factors for hypertension and other non-communicable diseases. The storytelling intervention was delivered by two DVDs three months apart; the didactic intervention included only one DVD. The trial was conducted in patients with poorly controlled hypertension from 4 communes (communities), which were equally randomized to the two interventions. RESULTS:The mean age of the 160 patients was 66 years and 54% were men. Between baseline enrollment and the 12 month follow-up, mean systolic blood pressure declined by 10.8 mmHg (95% CI: 6.5-14.9) in the storytelling group and by 5.8 mmHg (95% CI: 1.6-10.0) in the didactic content group. The storytelling group also experienced more improvement in several health behaviors, including increased levels of physical activity and reduced consumption of salt and alcohol. CONCLUSIONS:We observed considerable long-term beneficial effects of both interventions, especially of our storytelling intervention, among patients with inadequately controlled hypertension. A large scale randomized trial should more systematically compare the short and long-term effectiveness of the two interventions in controlling hypertension. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02483780.

Project description:BACKGROUND:Videoconferencing-based treatments have shown great potential in increasing engagement and compliance by decreasing the barriers of time and distance. In general, employees tend to experience a lot of stress, but find it difficult to visit a clinic during office hours. OBJECTIVE:The purpose of this study was to investigate the effectiveness of a mobile videoconference-based intervention for stress reduction and resilience enhancement in employees. METHODS:In total, 81 participants were randomly allocated to one of the three conditions: mobile videoconferencing, in-person, and self-care; of these, 72 completed the study. All participants underwent assessment via self-reported questionnaires before, immediately after, and 1 month after the intervention. Intervention lasted for 4 weeks and consisted of elements of cognitive behavioral therapy, positive psychology, and meditation. Changes in clinical variables regarding stress and resilience across time were compared between treatment conditions. RESULTS:There were significant condition × time effects on variables measuring perceived stress, resilience, emotional labor, and sleep, demonstrating significantly differential effects across time according to treatment condition. Moreover, there were significant effects of condition on perceived stress and occupational stress. There were no significant differences in any variable between the mobile videoconferencing and in-person conditions at 1 month after the intervention. CONCLUSIONS:Results indicate that both mobile videoconferencing and in-person interventions were comparably effective in decreasing stress and enhancing resilience. Further studies with a larger sample size and a longer follow-up period are warranted to investigate the long-term effect of mobile videoconferencing interventions. TRIAL REGISTRATION:ClinicalTrials.gov identifier NCT03256682; https://clinicaltrials.gov/ct2/show/NCT03256682 (Archived by WebCite at http://www.webcitation.org/71W77bwnR).

Project description:BackgroundThe adherence to cardiac rehabilitation is low. Social media has been used to improve motivation and cardiac rehabilitation completion, but the authors did not find Facebook interventions for these purposes in the literature.ObjectiveThe purpose of this study was to determine the feasibility of the Cardiac Rehabilitation Facebook Intervention (Chat) for affecting changes in exercise motivation and need satisfaction and adherence to cardiac rehabilitation.MethodsThe Behavioral Regulation in Exercise Questionnaire-3 and Psychological Need Satisfaction for Exercise were used to measure motivation and need satisfaction (competence, autonomy, and relatedness) before and after the Chat intervention. To support need satisfaction, the intervention included educational posts, supportive posts, and interaction with peers. The feasibility measures included recruitment, engagement, and acceptability. Groups were compared using analysis of variance and Kruskal-Wallis tests. Paired t tests were used to assess motivation and need satisfaction change, and Pearson or Spearman correlations were used for continuous variables.ResultsA total of 32 participants were lost to follow-up and 22 were included in the analysis. Higher motivation at intake (relative autonomy index 0.53, 95% CI 0.14-0.78; P=.01) and change in need satisfaction-autonomy (relative autonomy index 0.61, 95% CI 0.09-0.87; P=.02) were associated with more completed sessions. No between-group differences were found. Engagement included "likes" (n=210) and "hits" (n=157). For acceptability, mean scores on a 1 (not at all) to 5 (quite a bit) Likert scale for feeling supported and in touch with providers were 4.6 and 4.4, respectively.ConclusionsAcceptability of the Chat group was high; however, intervention feasibility could not be determined due to the small sample size. Those with greater motivation at intake completed more sessions, indicating its importance in cardiac rehabilitation completion. Despite challenges with recruitment and engagement, important lessons were learned.Trial registrationClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813.International registered report identifier (irrid)RR2-10.2196/resprot.7554.

Project description:BackgroundAs people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission.ObjectiveThis study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore.MethodsWe conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device-Medication Event Monitoring System (MEMS)-and a mobile app-MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention.ResultsAll participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results.ConclusionsAlthough MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app-assisted intervention RCTs in the future.Trial registrationClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648.

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.

Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:BackgroundSuboptimal 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.ObjectiveThe 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.MethodsWe 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.ResultsTo date, we have randomized 107 participants (54 intervention, 53 control).ConclusionsThis 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 registrationClinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271.International registered report identifier (irrid)DERR1-10.2196/25424.

Project description:BACKGROUND:The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. OBJECTIVE:This study aims to evaluate an MTH intervention among insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes-glycated hemoglobin (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviors, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients' perceptions of, and experience, using it. METHODS:A mixed-method design consisting of a 9-month, two-arm, parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months, and 9 months. Additional intervention fidelity data, such as participants' MTH transmissions and contacts with the MTH nurse during the study, were also recorded. RESULTS:Data collection for both the quantitative and qualitative components of this study has ended and data analysis is ongoing. A total of 86 participants were enrolled into the study. Out of 86 participants, 45 (52%) were randomized to the intervention group and 36 (42%) to the control group. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. We expect to publish complete study results in 2015. CONCLUSIONS:The range of data collected in this study will allow for a comprehensive evaluation of processes and outcomes. The early results presented suggest that MTH usage decreases over time and that MTH participants would benefit from attending more than one training session. TRIAL REGISTRATION:ClinicalTrials.gov NCT00922376; http://clinicaltrials.gov/ct2/show/NCT00922376 (Archived by WebCite at http://www.webcitation.org/6Vu4nhLI6).

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A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial.

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