Pharmacist intervention program to enhance hypertension control: a randomised controlled trial

Abstract Background Exclusive breastfeeding for the first 6 months of life is the optimal way to feed infants. However, recent studies suggest that exclusive breastfeeding rates in China remain low and are well below the recommended target. There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices. WeChat, the most widely used social networking platform in China, has shown some potential to promote health behaviours. We thus hypothesised that a breastfeeding intervention program delivered via WeChat would achieve at least a 10% increase in exclusive breastfeeding prevalence at 6 months compared to the control group. Methods A two-arm, parallel, multicentre randomised controlled trial of 1000 pregnant women will be conducted at four maternity hospitals of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 28–30 weeks of gestation, and randomly allocated to either the intervention group (participants receive breastfeeding-related information from WeChat) or the control group (participants receive non-breastfeeding information from WeChat) using a central randomisation system on a 1:1 ratio at each participating site. The primary outcomes are exclusive breastfeeding rate and full breastfeeding rate at 6 months postpartum. All randomised participants will be included in the outcome analyses with missing data being imputed based on the best-case and worst-case scenarios. Multilevel mixed regression models will be used in the primary analyses to assess the effectiveness of intervention program on the breastfeeding rates. Discussion This trial uses the most widely used social media program as a means of delivering messages to mothers to increase exclusive breastfeeding in China. Increasing exclusive breastfeeding will contribute to meeting the health and environmental goals of the Sustainable Development Guidelines. Trial registration ClinicalTrials.gov, NCT04499404. Registered 5 August 2020—Retrospectively registered, https://clinicaltrials.gov/show/NCT04499404

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Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study

BMJ Open ◽

10.1136/bmjopen-2018-022317 ◽

2018 ◽

Vol 8 (8) ◽

pp. e022317 ◽

Cited By ~ 1

Author(s):

Abdul Salam ◽

Ruth Webster ◽

Anushka Patel ◽

Pavithra Godamunne ◽

Arunasalam Pathmeswaran ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Process Evaluation ◽

Healthcare Professionals ◽

Antihypertensive Drugs ◽

Controlled Trial ◽

Uncontrolled Hypertension ◽

Hypertension Control ◽

Framework Analysis ◽

Middle Income ◽

Randomised Controlled

IntroductionGlobally, the prevalence of uncontrolled hypertension is high, particularly in low- and middle-income countries. There is a critical need for strategies to improve hypertension control. The early use of a fixed low-dose combination of three antihypertensive drugs (triple pill) has the potential to significantly improve hypertension control. TheTRIple Pill vs.Usual careManagement forPatients with mild-to- moderateHypertension (TRIUMPH) randomised controlled trial (RCT) is designed to test the effects of this strategy compared with usual care in patients with mild-to-moderate hypertension. This paper reports the protocol of a process evaluation of the TRIUMPH RCT. The objectives are to understand factors related to implementation of the intervention, mechanisms of effect, contextual factors that underpin the effectiveness of the triple pill strategy and the potential barriers and facilitators to implementing the strategy in clinical practice.Methods and analysisFace-to-face semistructured in-depth interviews with a purposive sample of TRIUMPH RCT participants and healthcare professionals in Sri Lanka will be conducted. Healthcare professionals will include physicians and their staff who were involved in conducting the TRIUMPH RCT. Interviewees will be recruited sequentially until thematic saturation is achieved. Interviews will be audio recorded, transcribed verbatim and analysed in NVivo using framework analysis methods.Ethics and disseminationThe TRIUMPH RCT and process evaluation have received approval from the relevant Ethics Review Committee. All participants will be asked to provide written consent before participation. Findings from the study will be disseminated through publications and conference presentations.Trial registration numberACTRN12612001120864 , SLCTR/2015/020 ; Pre-results.

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Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial protocol

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20190258 ◽

2019 ◽

Vol 6 (1) ◽

pp. 23

Author(s):

Hosam Alzahrani ◽

Martin Mackey ◽

Emmanuel Stamatakis ◽

Marina B. Pinheiro ◽

Debra Shirley

Keyword(s):

Physical Activity ◽

Low Back Pain ◽

Back Pain ◽

High Risk ◽

Randomised Controlled Trial ◽

Intervention Program ◽

Controlled Trial ◽

Low Back ◽

Walking Intervention ◽

Randomised Controlled

Background: The lifetime prevalence of low back pain (LBP) has been reported to be as high as 84% worldwide. Around 23% of the population has chronic non-specific LBP. Despite the potential health benefits of walking, few studies have investigated its effectiveness in people with non-specific LBP. The primary objective is to examine the efficacy of a Fitbit facilitated walking intervention in people with LBP with medium or high risk of chronicity in reducing disability and pain. The secondary objective is to investigate the efficacy of a Fitbit facilitated walking intervention in increasing physical activity levels in people with LBP.Methods: This prospective, randomised controlled trial will involve 68 participants. This study will recruit participants who are aged 18 years or over, have been diagnosed with non-specific LBP with medium or high risk of chronicity and classified as physically inactive. Participants will be randomised into two groups: usual physiotherapy care (n=34) and usual physiotherapy care plus Fitbit facilitated walking intervention program (n=34). The treatment duration will be 8 weeks. Primary outcomes for this study are disability and pain. Secondary outcomes include physical activity level and walking steps, depression, fear of movement and pain catastrophising. The outcomes will be assessed at baseline, post-intervention and 26 weeks post-randomisation follow-up.Conclusions: The results of this study will provide empirical evidence on the efficacy of a Fitbit facilitated walking intervention program, when added to usual care, in a clinical setting for improving disability and pain, and other clinical outcomes in people with LBP.Trial Registration: Australian New Zealand clinical trials registry (Number ACTRN12617001404314).

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