scholarly journals Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033920
Author(s):  
Aida Farhana Suhaimi ◽  
Normala Ibrahim ◽  
Kit-Aun Tan ◽  
Umi Adzlin Silim ◽  
Gaye Moore ◽  
...  
Keyword(s):  
Mental Health ◽  
Diabetes Mellitus ◽  
Primary Care ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Well Being ◽  
Patients With Diabetes ◽  
Biopsychosocial Intervention ◽  
Randomised Controlled ◽  
Primary Healthcare Clinics

IntroductionPeople with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia’s first OHP was developed under the name ‘Pohon Sihat’ (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus.Methods and analysisThis biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.Ethics and disseminationThis study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.Trial registration numberNCT03601884.

Telemedicine consultation for patients with diabetes mellitus: a cluster randomised controlled trial

2017 ◽  
Vol 24 (6) ◽  
pp. 385-391 ◽  
Author(s):  
Ajay Sood ◽  
Sharon A Watts ◽  
Julie K Johnson ◽  
Stacey Hirth ◽  
David C Aron
Keyword(s):  
Diabetes Mellitus ◽  
Primary Care ◽  
Health Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Telemedicine Consultation ◽  
Patients With Diabetes ◽  
Randomised Controlled

Introduction There is a widening discrepancy between the increasing number of patients with diabetes mellitus and the health care resources available to manage these patients. Telemedicine has been used in a number of instances to improve and deliver health care where traditional care delivery methods may encounter difficulty. We conducted a cluster randomised controlled trial of telemedicine consultation to manage patients with diabetes mellitus. Methods Eleven primary care centres attached to one Veteran Administration tertiary care centre were randomised to provide patients with diabetes consultation referral either by usual consultation in diabetes clinic or telemedicine consultations via videoconference. Results Altogether, 199 patients were managed by telemedicine consultation and 83 by usual consultation. Patients in both groups showed a small decrease in haemoglobin A1c, with no statistical difference between the groups (telemedicine consultation −1.01% vs usual consultation −0.68%, p = 0.19). Surveys of patients and semi-structured interviews with primary care providers showed better response and satisfaction with telemedicine consultations. Discussion This study shows similar clinical outcomes as measured by glycaemic control for patients with diabetes mellitus having a specialist consultation using real-time telemedicine consultation as compared to in-clinic consultation. Telemedicine consultation was also associated with better patient and primary care provider satisfaction.

scholarly journals E-healthcare for diabetes mellitus type 2 patients – a randomised controlled trial in Slovenia

2017 ◽  
Vol 56 (3) ◽  
pp. 150-157 ◽  
Author(s):  
Rade Iljaž ◽  
Andrej Brodnik ◽  
Tatjana Zrimec ◽  
Iztok Cukjati
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Nurse Practitioners ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Patients With Diabetes ◽  
Randomised Controlled ◽  
Interventional Group

Abstract Background Telemonitoring and web-based interventions are increasingly used in primary-care practices in many countries for more effective management of patients with diabetes mellitus (DM). A new approach in treating patients with diabetes mellitus in family practices, based on ICT use and nurse practitioners, has been introduced and evaluated in this study. Method Fifteen Slovene family practices enrolled 120 DM patients treated only with a diet regime and/or tablets into the study. 58 of them were included into the interventional group, and the other 62 DM patients into the control group, within one-year-long interventional, randomised controlled trial. Patients in the control group had conventional care for DM according to Slovenian professional guidelines, while the patients in the interventional group were using also the eDiabetes application. Patients were randomised through a balanced randomisation process. Results Significant reductions of glycated haemoglobin (HbA1c) values were found after 6 and 12 months among patients using this eDiabetes application (p<0.05). Among these patients, a significant correlation was also found between self-monitored blood pressure and the final HbA1c values. Diabetic patients’ involvement in web-based intervention had only transient impact on their functional health status. Conclusion This eDiabetes application was confirmed to be an innovative approach for better self-management of DM type 2 patients not using insulin. Both a significant reduction of HbA1c values and a significant correlation between the average self-measured blood pressure and the final HbA1c values in the interventional group were found. Nurse practitioners – as diabetes care coordinators – could contribute to better adherence in diabetes e-care.

scholarly journals School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029044 ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Implementation Evaluation ◽  
Cluster Randomised ◽  
Parallel Group ◽  
Randomised Controlled

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

scholarly journals Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol forMySweetHeart Trial, a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e020462 ◽  
Author(s):  
Antje Horsch ◽  
Leah Gilbert ◽  
Stefano Lanzi ◽  
Justine Gross ◽  
Bengt Kayser ◽  
...  
Keyword(s):  
Mental Health ◽  
Diabetes Mellitus ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Link Type ◽  
Health Need ◽  
Randomised Controlled

IntroductionGestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the mother or the child and take place either during or after pregnancy, while their results are inconsistent. To increase efficacy of intervention, the multifactorial origins of GDM and the tight link between mental and metabolic as well as maternal and child health need to be heeded. This calls for an interdisciplinary transgenerational approach starting in, but continuing beyond pregnancy.Methods and analysisThis randomised controlled trial will assess the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention aimed at improving the metabolic and mental health of 200 women with GDM and their offspring. Women with GDM at 24–32 weeks gestational age who understand French or English, and their offspring and partners can participate. The intervention components will be delivered on top of usual care during pregnancy and the first year postpartum. Metabolic and mental health outcomes will be measured at 24–32 weeks of pregnancy, shortly after birth and at 6–8 weeks and 1 year after childbirth. Data will be analysed using intention-to-treat analyses. TheMySweetHeart Trialis linked to theMySweetHeart Cohort(clinicaltrials.gov/ct2/show/NCT02872974).Ethics and disseminationWe will disseminate the findings through regional, national and international conferences and through peer-reviewed journals.Trial registration numberNCT02890693; Pre-results.

Perceived acceptability and experience of COPe-support - a digital psychoeducation and peer support intervention: Interview study with carers supporting individuals with psychosis (Preprint)

2021 ◽  
Author(s):  
Rachel Batchelor ◽  
Sarah Gulshan ◽  
Halpana Shritharan ◽  
Elen Williams ◽  
Claire Henderson ◽  
...  
Keyword(s):  
Mental Health ◽  
Computer Literacy ◽  
Care Delivery ◽  
Controlled Trial ◽  
Scale Up ◽  
Well Being ◽  
Online Chat ◽  
Loved One ◽  
Self Confidence ◽  
Randomised Controlled

BACKGROUND Digital mental health interventions offer a novel, accessible and self-paced approach to care delivery to family carers, i.e., relatives and close friends who support a loved one with psychosis. We co-produced COPe-support, a psychoeducational intervention delivered via an enriched online environment with network support from professionals and peers. In addition to rigorous investigation of the effectiveness of COPe-support on carers’ wellbeing and mental health outcomes, it is imperative to understand carers’ experiences in using the digital intervention and its associated online implementation and facilitation strategies. OBJECTIVE This study aimed to explore (1) carers’ experience and perceived acceptability of COPe-support and its different components, and (2) how they found engagement with COPe-support affected their own wellbeing and caregiving. METHODS We conducted a qualitative study, individually interviewing 35 carers after their use of COPe-support for 8 months through an online randomised controlled trial across England. A semi-structured guide with open-ended questions was used to explore carers’ experience and perceived acceptability of the intervention, and their ideas to improve the provision. All interviews were conducted remotely through mobile phone or internet communication media, audio-recorded, and transcribed verbatim. We used the thematic analysis framework approach to analyse the data. RESULTS Three key themes were identified: (i) remote, flexible and personalised, (ii) impacts on well-being and outlook on caregiving, and (iii) future implementation and integration with existing services. Overall, carers identified COPe-support as a helpful resource for themselves and for their caregiving role. Participants’ experiences, usage and activity on COPe-support varied a great deal and differed amongst carers of various ages and level of computer literacy. CONCLUSIONS Carers found COPe-support a flexible source of knowledge and support from professionals and peers which they can personalise to suit their own needs and convenience. Participants described gaining self-confidence, hope, and a sense of connectivity with others in a similar situation which helped ameliorate isolation and perceived stigma. Most importantly, COPe-support promoted self-care in the carers themselves. While nearly all participants had a positive experience with COPe-support and supported its wider implementation as a beneficial adjunctive support resource for carers in the future, they suggested some improvements. These include having more graphics and visual-audio content materials, improving the navigation and building in more interactional and customisation options to suit various users’ style (e.g. emoji reactions, live online chat, opting in-and-out of updates and choosing frequency of reminders). Any future scale-up of such an intervention should also consider factors pertinent to reaching more carers and integrating the digital resource with other conventional services. CLINICALTRIAL Current Controlled Trials registration ISRCTN 89563420.

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