scholarly journals The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration

2019 ◽  
Vol 30 (5) ◽  
pp. 890-903 ◽  
Author(s):  
Laura M. Dember ◽  
Eduardo Lacson ◽  
Steven M. Brunelli ◽  
Jesse Y. Hsu ◽  
Alfred K. Cheung ◽  
...  
Keyword(s):  
Usual Care ◽  
Care Delivery ◽  
Clinical Care ◽  
Pragmatic Trial ◽  
Intervention Group ◽  
Time Trial ◽  
Hospitalization Rate ◽  
Maintenance Hemodialysis ◽  
Session Duration ◽  
Cluster Randomized

BackgroundData from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established.MethodsTo develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients.ResultsThe trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care.ConclusionsAlthough a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

scholarly journals Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

2021 ◽  
Author(s):  
Michele Heisler ◽  
Jennifer Burgess ◽  
Jeffrey Cass ◽  
John F. Chardos ◽  
Alexander B. Guirguis ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Usual Care ◽  
Health Systems ◽  
Pragmatic Trial ◽  
Veterans Affairs ◽  
Control Group ◽  
Shared Medical Appointments ◽  
Site Cluster ◽  
Cluster Randomized

Abstract Objective To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements. Research Design and Methods A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs. Results Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group. Conclusions Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention. Trial Registration ClinicalTrials.gov ID NCT02132676

scholarly journals Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Duc A. Ha ◽  
Oanh T. Tran ◽  
Hoa L. Nguyen ◽  
Germán Chiriboga ◽  
Robert J. Goldberg ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Practice Change ◽  
Control Measures ◽  
Care Providers ◽  
Effective Prevention ◽  
Multi Media ◽  
Cluster Randomized

Abstract Background Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design. Methods Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a “storytelling intervention,” which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well. Discussion Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam. Trial registration ClinicalTrials.gov NCT03590691. Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.

Changing the Obesogenic Environment to Improve Cardiometabolic Health in Residential Patients with a Severe Mental Illness: ELIPS, a Randomized Controlled Trial

2017 ◽  
Vol 41 (S1) ◽  
pp. S267-S268 ◽  
Author(s):  
F. Jörg ◽  
A. Looijmans ◽  
A. Stiekema ◽  
L. Van der Meer ◽  
R. Schoevers ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Controlled Trial ◽  
Clinical Care ◽  
Pragmatic Trial ◽  
Intervention Group ◽  
Cardiometabolic Health ◽  
Control Group ◽  
Obesogenic Environment ◽  
Randomized Controlled ◽  
Small Change

IntroductionThe life expectancy of severe mentally ill (SMI) patients is shortened up to 30 years, due to cardiometabolic diseases, partly caused by unhealthy lifestyles behaviors. In residential facilities, adopting a healthy lifestyle is hampered by the obesogenic environment; an obesity promoting environment.ObjectiveTo determine, the effectiveness of a 12 month lifestyle intervention addressing the obesogenic environment to improve cardiometabolic health of SMI residential patients.MethodsThe effectiveness of lifestyle interventions in psychiatry (ELIPS) trial is a multi-site, cluster randomized controlled pragmatic trial. Twenty-nine sheltered and long-term clinical care teams serving SMI patients in the Netherlands were randomized into intervention (n = 15) or control (n = 14) arm, including 736 patients (73% psychotic disorder, 63% male, 48 ± 13 years). The intervention aimed to improve the obesogenic environment using a small change approach with a focus on nutrition and physical activity. Primary outcome was waist circumference (WC) after three and twelve month's intervention. Secondary outcomes were BMI and metabolic syndrome.ResultsGeneral linear mixed models adjusted for age, gender, housing facility and antipsychotic medication showed that WC significantly decreased with 1.51 cm (95%CI = −2.99;−0.04, Cohen's d = 0.07) in the intervention group compared to control group after three months and tended to remain lower with 1.28 cm (95%CI = −2.79; 0.23, Cohen's d = 0.06) after twelve months. Metabolic syndrome Z-score decreased after three months with 0.225 SD (95% CI = −0.4038;−0.096, Cohen's d = 0.20), mainly due to lower fasting glucose and WC. No significant effects were found on BMI.ConclusionA small change approach targeting the obesogenic environment of SMI residential patients reduces cardiometabolic risk.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Screening and patient-tailored care for emotional and cognitive problems compared to care as usual in patients discharged home after ischemic stroke (ECO-stroke): a protocol for a multicenter, patient-blinded, cluster randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
J. P. L. Slenders ◽  
R. M. Van den Berg-Vos ◽  
C. M. van Heugten ◽  
J. M. A. Visser-Meily ◽  
S. M. A. A. Evers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Emotional Problems ◽  
Clinical Effectiveness ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke. Methods / design A multicenter, patient-blinded, cluster randomized controlled trial will be performed. Centers will be randomized (1:1) to the intervention group or the usual care group. Patients (> 18 years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included. In the intervention group, patients will receive a short, individualized, semi-structured consultation by specialized nurses in addition to usual care. This consultation includes 1) screening for cognitive and emotional problems, 2) screening for restrictions in participation, 3) promotion of self-management strategies and 4) a decision tool for referral to rehabilitation services. The intervention will be performed approximately 6 weeks after the stroke at the neurology outpatient clinics and will take approximately 60 min. The control group will receive care as usual. Both groups will be followed-up at 6 weeks, 3 months and 12 months after stroke. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months. A cost-effectiveness analysis and process evaluation will be performed alongside. Discussion This trial is the first to evaluate clinical effectiveness, cost-effectiveness and implementation of screening and patient-tailored care for cognitive and emotional problems compared to care as usual in patients discharged home after ischemic stroke. Potentially, this will improve the outcomes for patients with frequently occurring cognitive and emotional problems after stroke. Trial registration Netherlands Trial Register: NL7295, registered 25 September 2018

scholarly journals Effectiveness of a multidisciplinary BIOPSYCHOSOCIAL intervention for non-specific SUBACUTE low back pain in a working population: a cluster randomized clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Romina Raczy Mas ◽  
Tomàs López-Jiménez ◽  
Enriqueta Pujol-Ribera ◽  
María Isabel Fernández-San Martín ◽  
Jenny Moix-Queraltó ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Care ◽  
Intervention Group ◽  
Control Group ◽  
Low Back ◽  
Working Population ◽  
Multidisciplinary Intervention ◽  
Biopsychosocial Intervention ◽  
Cluster Randomized

Abstract Background Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2–12 weeks), non-specific LBP. Methods Longitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18–65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used. Results Of the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12. Conclusions A multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life. Trial registration ISRCTN21392091 (17 oct 2018) (Prospectively registred).

scholarly journals Conquering Hypertension in Vietnam- Solutions at Grassroots Level: Study Protocol of a Cluster Randomized Controlled Trial

2020 ◽  
Author(s):  
Duc Ha ◽  
Oanh Tran ◽  
Hoa Nguyen ◽  
Robert Goldberg ◽  
German Chiriboga ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Practice Change ◽  
Control Measures ◽  
Care Providers ◽  
Epidemiologic Transition ◽  
Effective Prevention ◽  
Cluster Randomized

Abstract Background Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster-randomized trial design. MethodsSixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home BP self-monitoring; and (3) a “storytelling intervention”, which consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.DiscussionResults from this full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.Trial registration: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).Protocol version: 6. Date: 08/15/2019

Decision aids for localized prostate cancer: Initial outcomes from NCI Community Oncology Research Program Alliance Research Base Cancer Care Delivery Research (CCDR) Protocol - A191402CD - A Cluster-Randomized Trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24176-e24176
Author(s):  
Jon Charles Tilburt ◽  
Joel E Pacyna ◽  
Daniel G. Petereit ◽  
Judith Salmon Kaur ◽  
Bruce D. Rapkin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Usual Care ◽  
Care Delivery ◽  
Decision Aids ◽  
Clinical Stage ◽  
Cluster Randomized Trial ◽  
Relative Effect ◽  
Oncology Research ◽  
Cluster Randomized ◽  
Cluster Correlation

e24176 Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .

scholarly journals Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030788 ◽  
Author(s):  
Tobias Stenlund ◽  
André Nyberg ◽  
Sara Lundell ◽  
Karin Wadell
Keyword(s):  
Usual Care ◽  
Behaviour Change ◽  
Primary Healthcare ◽  
Healthcare Professionals ◽  
Management Strategies ◽  
Pragmatic Trial ◽  
Intervention Group ◽  
Self Management ◽  
Ethical Review ◽  
Web Based

IntroductionThe use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context.Methods and analysisThe overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessments, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants’ PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up.Ethics and disseminationEthical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274-31. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations.Trial registration numberNCT03746873

scholarly journals Study Protocol: Partners at Meals Telehealth Intervention for Caregivers of Persons With Dementia

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 278-278
Author(s):  
Suparna Qanungo ◽  
Elaine Amella Krug ◽  
Kelly Martin ◽  
Martina Mueller ◽  
Mohan Madisetti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Study Protocol ◽  
Controlled Trial ◽  
Intervention Group ◽  
Train The Trainer ◽  
Telehealth Intervention ◽  
Alzheimer's Caregiving ◽  
Cluster Randomized

Abstract Background: As the aging population continues to increase, it is estimated that persons with dementias (PWDs) will reach 13 million by 2050. Lack of caregiver skills related to mealtime planning and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional outcomes for PWDs, leading to social isolation, and negatively impacting their home stay. The aim of this study protocol is to test the effectiveness of a train-the-trainer program in which non-paid volunteers in respite care centers deliver a telehealth mealtime intervention for caregivers of PWDs, Partners at Meals. The program is based on the C3P Model of Changing the Place, People and Person. Methods: A cluster-randomized controlled trial with parallel mixed methods evaluation processes is being conducted. Caregivers and PWD dyads, receiving respite services are randomized to receive Partners at Meals or enhanced-usual-care for six months. Within the intervention group, dyads are partnered with a C3P-trained volunteer who works with caregivers to devise monthly mealtime plans. Under enhanced-usual-care, dyads receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer’s caregiving. Primary outcomes include weight, calorie, protein and fluid intake of the PWDs and quality of life of the caregiver. Respite center administrators, program directors, volunteers and caregivers are evaluated for intervention fidelity, acceptability and sustainability. Implications: In this trial, we lay the groundwork to examine effectiveness and sustainability of a train-the-trainer telehealth program that could be widely disseminated for managing mealtimes in-the-home, while promoting quality of life of both the caregiver and PWDs.

scholarly journals Conquering Hypertension in Vietnam- Solutions at Grassroots Level: Study Protocol of a Cluster Randomized Controlled Trial

2020 ◽  
Author(s):  
Duc Ha ◽  
Oanh Tran ◽  
Hoa Nguyen ◽  
Robert Goldberg ◽  
German Chiriboga ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Health Care Providers ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Practice Change ◽  
Control Measures ◽  
Care Providers ◽  
Effective Prevention ◽  
Cluster Randomized

Abstract BackgroundVietnam has been experiencing an epidemiologic transition to that of a low-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster-randomized trial design. MethodsSixteen communities will be randomized to either an intervention (8 communities) or comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services; (2) home blood pressure (BP) self-monitoring; and (3) a “storytelling intervention.”. which consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voice. The storytelling intervention will be delivered by DVD, with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.DiscussionResults from this full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.Trial registration: ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).Protocol version: 6. Date: 08/15/2019

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