Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol

Background: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. Methods: A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy. Results: 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]). Conclusions: Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.

Download Full-text

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

BMJ Open ◽

10.1136/bmjopen-2017-020762 ◽

2018 ◽

Vol 8 (3) ◽

pp. e020762 ◽

Cited By ~ 2

Author(s):

Samantha Sabo ◽

Catalina Denman Champion ◽

Melanie L Bell ◽

Elsa Cornejo Vucovich ◽

Maia Ingram ◽

...

Keyword(s):

Risk Factors ◽

Primary Care ◽

Cardiovascular Risk ◽

Randomised Trial ◽

Cvd Risk ◽

Cluster Randomised ◽

Primary Care Health ◽

Care Health ◽

Diabetic Population ◽

The University

IntroductionNorthern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system.Methods and analysisThe Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors.Ethics and disseminationThis work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials.Trial registration numberNCT0280469; Pre-results.

Download Full-text

Supervised treatment in outpatients for schizophrenia plus (STOPS+): protocol for a cluster randomised trial of a community-based intervention to improve treatment adherence and reduce the treatment gap for schizophrenia in Pakistan

BMJ Open ◽

10.1136/bmjopen-2019-034709 ◽

2020 ◽

Vol 10 (6) ◽

pp. e034709

Author(s):

Thomas Andrew Shepherd ◽

Zia Ul-Haq ◽

Mian Ul-Haq ◽

Muhammad Firaz Khan ◽

Adil Afridi ◽

...

Keyword(s):

Primary Care ◽

Treatment Adherence ◽

Low Income ◽

Tertiary Care ◽

Randomised Trial ◽

Ethical Review ◽

Treatment Gap ◽

Community Based ◽

Level Of Functioning ◽

Cluster Randomised

IntroductionThere is a significant treatment gap, with only a few community-based services for people with schizophrenia in low-income and middle-income countries. Poor treatment adherence in schizophrenia is associated with poorer health outcomes, suicide attempts and death. We previously reported the effectiveness of supervised treatment in outpatients for schizophrenia (STOPS) for improving treatment adherence in patients with schizophrenia. However, STOPS was evaluated in a tertiary care setting with no primary care involvement, limiting its generalisability to the wider at-risk population. We aim to evaluate the effectiveness of STOPS+ in scaling up the primary care treatment of schizophrenia to a real-world setting.Methods and analysisThe effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design. We aim to recruit 526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to STOPS+ intervention and enhanced treatment as usual arms. Participants will be followed-up for 12 months postrecruitment. The sample size is estimated for two outcomes (1) the primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen measured using a validated measure. An intention-to-treat approach will be used for the primary analysis.Ethics and disseminationEthical approval has been obtained from Keele University Ethical Review Panel (ref: MH-190017) and Khyber Medical University Ethical Review Board (ref: DIR-KMU-EB/ST/000648). The results of the STOPS+ trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers.Trial registration numberISRCTN93243890.

Download Full-text

Effects of an electronic software ‘prompt’ with healthcare professional training on cardiovascular and renal complications in a multi-ethnic population with Type 2 Diabetes and Microalbuminuria (The GP Prompt study): results of a pragmatic cluster randomised trial.

10.2337/figshare.12114174.v1 ◽

2020 ◽

Author(s):

Andrew Willis ◽

Winston Crasto ◽

Laura J Gray ◽

Helen Dallosso ◽

Ghazala Waheed ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Cardiovascular Risk ◽

Odds Ratio ◽

Cardiovascular Events ◽

Primary Outcome ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

Background: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes (T2DM) and microalbuminuria. The effects of using an electronic “Prompt” with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. Methods: A multi-centre, cluster-randomised trial among primary care practices across Leicestershire, UK. Primary outcome was proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80mmHg, respectively) and total cholesterol (<3.5mmol/l) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c<58 mmol/mol (<7.5%), changes in prescribing, change in albumin-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality and coding accuracy. Results: 2721 individuals from 22 practices, mean age 63 years, 41% female, 62% from Black and Minority Ethnic groups, completed two years follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the pre-specified outcome of total cholesterol <4.0 mmol (Odds Ratio 1.24(1.05,1.47),p=0.01) increased with intensive intervention compared to control. Coding for microalbuminuria increased relative to control (Odds Ratio 2.05 (1.29, 3.25), p< 0.01]). Conclusions: Greater improvements in composite cardiovascular risk factor control with this intervention compared to standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies including patient education and healthcare professional engagement, in the management of T2DM.

Download Full-text