Targets and self management for the control of blood pressure in stroke and other at-risk groups (TASMIN-SR): a randomised controlled trial

2012 ◽  
Author(s):  
Emma Bray
Keyword(s):  
Blood Pressure ◽  
At Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Risk Groups ◽  
Self Management ◽  
Randomised Controlled

scholarly journals Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention (SNAP-HT)

2020 ◽  
Author(s):  
Alexandra Elspeth Cairns ◽  
Katherine L. Tucker ◽  
Carole Crawford ◽  
Richard J. McManus ◽  
John Powell
Keyword(s):  
Blood Pressure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Blood Pressure Monitoring ◽  
Controlled Trial ◽  
Mixed Methods Study ◽  
Self Management ◽  
Normalisation Process Theory ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.

scholarly journals Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention

2019 ◽  
Author(s):  
Alexandra Elspeth Cairns ◽  
Katherine L. Tucker ◽  
Carole Crawford ◽  
Richard J. McManus ◽  
John Powell
Keyword(s):  
Blood Pressure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Blood Pressure Monitoring ◽  
Controlled Trial ◽  
Mixed Methods Study ◽  
Self Management ◽  
Normalisation Process Theory ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated that adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with both a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.

Effectiveness of a family nurse‐led programme on accuracy of blood pressure self‐measurement: A randomised controlled trial

2021 ◽  
Author(s):  
Valentina Simonetti ◽  
Dania Comparcini ◽  
Marco Tomietto ◽  
Daniele Pavone ◽  
Maria Elena Flacco ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness–implementation randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e048350
Author(s):  
Monika Kastner ◽  
Julie Makarski ◽  
Leigh Hayden ◽  
Jemila S Hamid ◽  
Jayna Holroyd-Leduc ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Disease ◽  
Randomised Controlled Trial ◽  
Disease Management ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Management Tool ◽  
Self Management ◽  
Plain Language ◽  
Randomised Controlled

IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Swāsthya, an integrated chronic condition management programme for families of patients with hypertension and diabetes mellitus: a study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M D Saju ◽  
Bindiya M Varghese ◽  
Lorane Scaria ◽  
Anuja Maria Benny ◽  
Shilpa V Yohannan ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Social Cohesion ◽  
Chronic Conditions ◽  
Chronic Condition ◽  
Controlled Trial ◽  
Risk Groups ◽  
Care Model ◽  
Randomised Controlled

Abstract Background Kerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, thus compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management. This paper describes the protocol of our study that aims to examine the effectiveness and sustainability of an integrated care model for the management of chronic conditions and their risk factors through a family-based intervention. The proposed care model targets to modify systems and processes that predispose to chronic conditions by enhancing social cohesion and social networks, preventing lifestyle risks, developing iterative cognitive interventions, and engaging the family into customised treatment adherence strategies navigated by community health social workers (CHSWs). Methods A cluster randomised controlled trial (RCT) in selected participants will be conducted involving additional assessments prior to the baseline assessment. The assessment will identify and categorise patients into four risk groups, namely behavioural, social, cognitive, and multiple, based on dominant risks identified. Eligible participants will be randomly allocated (at a ratio of 1:1) into the intervention or control arm. The intervention arm will receive social, behavioural, and cognitive or multiple interventions corresponding to the identified risk groups, whereas the control arm will receive general intervention. Both the groups will be followed up at 6 months and 12 months post baseline to measure outcomes. The primary outcome will be the control of HTN and DM, and secondary outcomes include decreased depression and anxiety and improved functioning, social cohesion, and social network linkages. The sustainability and scalability of this intervention will be assessed through cost effectiveness, acceptability, and user friendliness of the integrated approach by performing a qualitative evaluation. Discussion This RCT will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by CHSWs. Such a model is not currently considered in the management of chronic conditions in Kerala. Trial registration Trial has been prospectively registered on Clinical Trial Registry of India- CTRI/2020/12/029474 on 1st December 2020.

A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

1995 ◽  
Vol 2 (4) ◽  
pp. 211-218 ◽  
Author(s):  
Jenny Bowman ◽  
Rob Sanson-Fisher ◽  
Catherine Boyle ◽  
Stephanie Pope ◽  
Sally Redman
Keyword(s):  
At Risk ◽  
Randomised Controlled Trial ◽  
Pap Smear ◽  
Controlled Trial ◽  
Self Report ◽  
Health Clinic ◽  
Control Group ◽  
Screening Attendance ◽  
Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

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